Venous ThromboembolismFAST&THROMBINNCT06418633
Variations in the Hemostatic System Induced by a Standardized Walking Test
A study testing 60-minute walking test, Static blood test and Post-effort blood test in people with Venous Thromboembolism, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
Two groups of patients will be compared: One group of patients with a history of venous thromboembolic disease and one group without. Both groups will be subjected to a walking test and with electrocardiogram measurements and blood tests. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- 60-minute walking test, Static blood test and Post-effort blood test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteFrance
- Study dates
- 11 Feb 2025to 1 Apr 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who have given written informed consent.
- Patients who are affiliated to or beneficiaries of a social security scheme.
- Patients with a personal history of provoked venous thromboembolism, venous thrombosis and/or pulmonary embolism, with the last attack dating back to more than 6 months, and whose clinical phenotype did not justify long-term antithrombotic drug prophylaxis.
- Definition of provoked venous thromboembolism : The clinical criteria used to classify venous thromboembolism as provoked are :
- First year of combined oestrogen-progestogen oral contraception, or contraception using an oestrogen-impregnated vaginal ring or transcutaneous synthetic oestrogen patch.
- Hormonal stimulation for oocyte retrieval
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- Pregnancy and 6 weeks post-partum
- Surgery
- Trauma
- Immobilisation in plaster or splint
- Outbreak of acute infectious disease
- Acute flare-up of inflammatory disease
- Prolonged air travel lasting at least 4 hours
- Prolonged strict bed rest lasting at least 3 consecutive days.
- Subjects with no personal history of venous thromboembolism
- Subjects with no family history of venous thromboembolism in first-degree relatives
- Subjects of the same sex and age with a tolerance of +/- 5 years in relation to the matched case.
Who cannot join
- Patients who are physically unable to perform the 60-minute walking test, for any reason, in particular cardiovascular contraindications to exercise (recent acute coronary syndrome unstable angina, rhythm disorders, tight aortic stenosis, cardiac heart failure, acute myocarditis, pericarditis or endocarditis endocarditis, poorly controlled hypertension, pre-stress blood pressure > 200/110 mmHg, recent stroke or transient ischemic attack).
- Patients on anticoagulant or antithrombotic treatment, ongoing or discontinued within the last month.
- Patients treated for pulmonary embolism who remain dyspneic after anticoagulant treatment and requiring a work-up for pulmonary hypertension.
- Last surgery dating back to less than 3 months.
- Known chronic morbidities: diabetes mellitus, chronic inflammatory or infectious disease, heart failure, renal insufficiency, hepatic insufficiency or arterial thrombosis dating back to less than 3 months.
- For women: treatment containing synthetic or natural estrogen, in progress or discontinued for less than a month
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- Pregnancy within the last year.
- Difficult venous access.
- Regular practice of an intensive sporting/physical activity, such as running, tennis, cycling etc. of more than 3 hours per week.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Nîmes
Nîmes, Occitanie, 30029
Antonia PEREZ MARTIN, Pr., +33 4 66 68 33 13, antonia.prezmartin@chu-nimes.fr
About this study
Official title: Variations in the Hemostatic System Induced by a Standardized Walking Test: Controls vs. Cases With a History of Non-anticoagulated Venous Thromboembolic Disease
Two groups of patients will be compared: One group of patients with a history of venous thromboembolic disease and one group without. Both groups will be subjected to a walking test and with electrocardiogram measurements and blood tests.
Read the detailed description
Induced venous thromboembolism is a situation in which venous thromboembolic disease is triggered by an acute event that activates hemostasis: surgery, trauma, infectious or inflammatory outbreak, etc., a situation in which the risk of spontaneous recurrence, in the absence of a new provoking circumstance, is low, leading to the suggestion, not of long-term thromboprophylaxis, but simply the transient prevention of an event when there is a new clinical event likely to activate hemostasis. One such event is acute physical exertion.
Indeed, cohort studies seem to show that regular physical activity is associated with a low incidence of venous thromboembolism. Trained individuals have an endogenous thrombotic potential, assessed by the thrombin TGT test, lower than that of sedentary controls. A 3-month regimen of daily endurance exercise reduces thrombin generation controls and optimizes the fibrinolytic system. Repetitive exercise is accompanied by a depletion of exercise-induced platelet activation. However, several cases of venous thromboembolism have been reported in high-level athletes without usual risk factors and acute high-intensity rowing induces an acute increase in thrombin generation immediately after exercise, which disappears within 16 to 24 hours. The relationship between the level of physical activity and the risk of VTE could be a U-shaped relation, with an increasing risk of event in intense acute practice.
However, no data exists on the hemostatic impact of an acute session of physical activity in patients with a history of venous thromboembolism. Thus, the hypothesis is that exercise-induced response of hemostasis differ in patients with an history of provoked VTE compared to subjects without a history of venous thromboembolism.
This is a proof-of-concept, pathophysiological, single-center, cross-sectional, prospective comparison study of a group of patients with a personal history of induced Venous thromboembolism to a group of sex- and age- and sex-matched controls (+/- 5 years).
- Type of clinical study: Stress test-induced variations in parameters describing the results of the thrombin generation test (Thromboscreen®) in a group of Patients (Cases) will be compared with those obtained in a group of Control subjects (Controls) with a ratio 1:1.
The Patients group comprises 47 patients with a personal history of induced venous thromboembolism, the last event dating back to more than 6 months, whose clinical phenotype did not justify long-term antithrombotic drug prophylaxis.The Control group comprises 47 patients with no personal history of venous thromboembolism and no family history of venous thromboembolism in first-degree relatives.
The study intervention consists of an hour-long walking test and two blood tests in both groups for all participants (Controls and Patients).
- Intra-individual reproducibility will be analyzed in 20 subjects (10 patients and 10 controls) who will take the walking test twice on two separate days.
Patients will be selected during a venous thromboembolism follow-up consultation by a physician from either department (Vascular Medicine Consultation or Biological Hematology and Consultations).Inclusion and non-inclusion criteria will be checked, and the study will be explained to participants (patients and controls).Patients and controls will be systematically asked to take part in the variability analysis on a voluntary basis, until 10 subjects per group have agreed to carry out the second test.
The walking test is performed in the morning, 2 hours after a standard breakfast, on a treadmill. It will be preceded by a clinical examination, a resting 12-lead electrocardiogram and a brachial pressure measurement. After a 3-minute warm-up and "habituation" period (walking speed 2.5 km per hour with no incline), the speed and incline will be gradually increased until a target heart rate close to the theoretical ventilatory threshold, and of the order of 70% of the theoretical maximum value (evaluated by Astrand's formula: 220-age), so as to maintain aerobic exercise conditions of moderate intensity, enabling prolonged effort to be maintained. Blood samples will be taken from each participant whilst at rest, before undergoing the 60-minute walking test, in a sitting position, and just after the exercise test.
- Conditions
- Venous Thromboembolism
- Being tested
- 60-minute walking test, Static blood test, Post-effort blood test, Electrocardiogram, Blood pressure monitoring
- Keywords
- Physical exercise
- Medical subject headings
- Venous Thromboembolism, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
60-minute walking testOther
Treadmill walking test in the morning, 2 hours after breakfast, following a clinical examination, resting 12-lead electrocardiogram and blood pressure measurement. After a 3-minute warm-up and walking of speed 2.5 km per hour, no incline, the speed and incline are gradually increased to reach a target heart rate close to the theoretical ventilatory threshold, around 70% of the theoretical maximum value (evaluated by Astrand's formula: 220-age), i.e. aerobic conditions of moderate intensity so that prolonged effort can be maintained. Test performed in presence of a physician trained in stress testing. Emergency cart and defibrillator available in the department. Intra-hospital vital emergency protocol in place, with resuscitation teams on standby. The cardiology department, in the same building, can be contacted in the event of a cardiological abnormality during the test or recovery. The test takes 60 minutes, including a 3-minute initial warm-up.
Static blood testDiagnostic test
33.3 ml of blood will be taken from each participant whilst at rest, before undergoing the 60-minute walking test
Post-effort blood testDiagnostic test
33.3 ml of blood will be taken from each participant immediately after undergoing the 60-minute walking test.
ElectrocardiogramOther
An electrocardiogram will be carried out throughout the exercise period and during the first 30 minutes of recovery.
Blood pressure monitoringOther
Blood pressure will be monitored out throughout the exercise period and during the first 30 minutes of recovery.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Subjects with neither a personal history nor family history of venous thromboembolism in first-degree relatives. Receives: Other: 60-minute walking test; Diagnostic Test: Static blood test; Diagnostic Test: Post-effort blood test; Other: Electrocardiogram; Other: Blood pressure monitoring |
| Patients | Active comparator | Patients with a personal history of induced venous thromboembolism, the last attack dating back to more than 6 months, whose clinical phenotype did not justify long-term antithrombotic drug prophylaxis Receives: Other: 60-minute walking test; Diagnostic Test: Static blood test; Diagnostic Test: Post-effort blood test; Other: Electrocardiogram; Other: Blood pressure monitoring |
| Individual reproducibility" subgroup: controls | Active comparator | 10 subjects with neither a personal history nor family history of venous thromboembolism in first-degree relatives who have accepted to re-do the test one week later. Receives: Other: 60-minute walking test; Diagnostic Test: Static blood test; Diagnostic Test: Post-effort blood test; Other: Electrocardiogram; Other: Blood pressure monitoring |
| Individual reproducibility" subgroup: patients | Active comparator | 10 patients with a history of induced venous thromboembolism, the last attack dating back to more than 6 months, whose clinical phenotype did not justify long-term antithrombotic drug prophylaxis, who have accepted to re-do the test one week later. Receives: Other: 60-minute walking test; Diagnostic Test: Static blood test; Diagnostic Test: Post-effort blood test; Other: Electrocardiogram; Other: Blood pressure monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thrombin generation dosage before effort in controls
The amount of thrombomodulin in the blood will be measured in nmol/L with the help of Thromboscreen(TM)
Measured: Day 0
Thrombin generation dosage before effort in patients
The amount of thrombomodulin in the blood will be measured in nmol/L with the help of Thromboscreen(TM)
Measured: Day 0
Thrombin generation dosage after effort in controls
The amount of thrombomodulin in the blood will be measured in nmol/L with the help of Thromboscreen(TM). The difference between measurements before and after effort will be measured in nM.min-1
Measured: Day 0
Thrombin generation dosage after effort in patients
The amount of thrombomodulin in the blood will be measured in nmol/L with the help of Thromboscreen(TM). The difference between measurements before and after effort will be measured in nM.min-1
Measured: Day 0
Thrombin generation dosage before effort in the "Individual reproducibility" subgroup: controls
The amount of thrombomodulin in the blood will be measured in nmol/L with the help of Thromboscreen(TM)
Measured: Day 7
Thrombin generation dosage before effort in the "Individual reproducibility" subgroup: patients
The amount of thrombomodulin in the blood will be measured in nmol/L with the help of Thromboscreen(TM)
Measured: Day 7
Thrombin generation dosage after effort in the "Individual reproducibility" subgroup: controls
The amount of thrombomodulin in the blood will be measured in nmol/L with the help of Thromboscreen(TM). The difference between measurements before and after effort will be measured in nM.min-1
Measured: Day 7
Thrombin generation dosage after effort in the "Individual reproducibility" subgroup: patients
The amount of thrombomodulin in the blood will be measured in nmol/L with the help of Thromboscreen(TM). The difference between measurements before and after effort will be measured in nM.min-1
Measured: Day 7
Secondary outcomes (230)
Distribution in the Control group
Measurements in nM.min-1 will be compared to elicit central tendency, dispersion and heterogeneity in the Control group
Measured: Day 0
Distribution in the Patient group
Measurements in nM.min-1 will be compared to elicit central tendency, dispersion and heterogeneity in the Patient group
Measured: Day 0
Thromboscreen test in Controls in the absence of thrombomodulin : Latency time
Latency time in the absence of thrombomodulin will be measured in seconds in Controls.
Measured: Day 0
Thromboscreen test in Controls in the absence of thrombomodulin : Thrombin peak intensity
Thrombin peak intensity in the absence of thrombomodulin will be measured in Controls.
Measured: Day 0
Thromboscreen test in Controls in the absence of thrombomodulin : Time-to-peak thrombin
Time-to-peak thrombin in the absence of thrombomodulin will be measured in Controls.
Measured: Day 0
Thromboscreen test in Controls in the absence of thrombomodulin : Initial thrombin generation velocity
Initial thrombin generation velocity in the absence of thrombomodulin will be measured in seconds in Controls.
Measured: Day 0
Thromboscreen test in Controls in the absence of thrombomodulin : Time to return to baseline
Time to return to baseline in the absence of thrombomodulin will be measured in seconds in Controls.
Measured: Day 0
Thromboscreen test in Controls in the presence of thrombomodulin : Latency time
Latency time in the presence of thrombomodulin will be measured in seconds in Controls.
Measured: Day 0
Thromboscreen test in Controls in the presence of thrombomodulin : Thrombin peak intensity
Thrombin peak intensity in the presence of thrombomodulin will be measured in Controls.
Measured: Day 0
Thromboscreen test in Controls in the presence of thrombomodulin : Time-to-peak thrombin
Time-to-peak thrombin in the presence of thrombomodulin will be measured in Controls.
Measured: Day 0
Thromboscreen test in Controls in the presence of thrombomodulin : Initial thrombin generation velocity
Initial thrombin generation velocity in the presence of thrombomodulin will be measured in seconds in Controls.
Measured: Day 0
Thromboscreen test in Controls in the presence of thrombomodulin : Time to return to baseline
Time to return to baseline in the presence of thrombomodulin will be measured in seconds in Controls.
Measured: Day 0
Thromboscreen test in Patients in the absence of thrombomodulin : Latency time
Latency time in the absence of thrombomodulin will be measured in seconds in Patients.
Measured: Day 0
Thromboscreen test in Patients in the absence of thrombomodulin : Thrombin peak intensity
Thrombin peak intensity in the absence of thrombomodulin will be measured in Patients.
Measured: Day 0
Thromboscreen test in Patients in the absence of thrombomodulin : Time-to-peak thrombin
Time-to-peak thrombin, initial thrombin generation velocity, time to return to baseline for the thrombin generation test performed in the absence of thrombomodulin will be measured in seconds in Patients.
Measured: Day 0
Thromboscreen test in Patients in the absence of thrombomodulin : Initial thrombin generation velocity
Initial thrombin generation velocity in the absence of thrombomodulin will be measured in seconds in Patients.
Measured: Day 0
Thromboscreen test in Patients in the absence of thrombomodulin : Time to return to baseline
Time to return to baseline in the absence of thrombomodulin will be measured in seconds in Patients.
Measured: Day 0
Thromboscreen test in Patients in the presence of thrombomodulin : Latency time
Latency time in the presence of thrombomodulin will be measured in seconds in Patients.
Measured: Day 0
Thromboscreen test in Patients in the presence of thrombomodulin : Thrombin peak intensity
Thrombin peak intensity in the presence of thrombomodulin will be measured in seconds in Patients.
Measured: Day 0
Thromboscreen test in Patients in the presence of thrombomodulin : Time-to-peak thrombin
Time-to-peak thrombin in the presence of thrombomodulin be measured in seconds in Patients.
Measured: Day 0
Thromboscreen test in Patients in the presence of thrombomodulin : Initial thrombin generation velocity
Initial thrombin generation velocity in the presence of thrombomodulin will be measured in seconds in Patients.
Measured: Day 0
Thromboscreen test in Patients in the presence of thrombomodulin : Time to return to baseline
Time to return to baseline in the presence of thrombomodulin will be measured in seconds in Patients.
Measured: Day 0
Distribution of other parameters of the Thromboscreen test in Controls
The distribution (central tendency, dispersion, heterogeneity), of the various biological parameters (latency time, thrombin peak intensity, time-to-peak thrombin, initial thrombin generation velocity, time to return to baseline) will be measured in Controls
Measured: Day 0
Distribution of other parameters of the Thromboscreen test in Patients
The distribution (central tendency, dispersion, heterogeneity), of the various biological parameters (latency time, thrombin peak intensity, time-to-peak thrombin, initial thrombin generation velocity, time to return to baseline) will be measured in Patients
Measured: Day 0
Endogenous Thrombotic Potential in the presence of thrombomodulin in Controls
nM.min
Measured: Day 0
Endogenous Thrombotic Potential in the absence of thrombomodulin in Controls
nM.min
Measured: Day 0
Endogenous Thrombotic Potential in the presence of thrombomodulin in Patients
nM.min
Measured: Day 0
Endogenous Thrombotic Potential in the absence of thrombomodulin in Patients
nM.min
Measured: Day 0
Heterogeneity of Endogenous Thrombotic Potential in Controls
Statistical analysis, Cochrane's Q test
Measured: Day 0
Heterogeneity of Endogenous Thrombotic Potential in Patients
Statistical analysis, Cochrane's Q test
Measured: Day 0
Complete Blood Count in Controls before the walking test: White blood cells
White blood cells will be measured in thousands/µL
Measured: Day 0
Complete Blood Count in Controls before the walking test: White blood cells
White blood cells will be measured in thousands/µL
Measured: Day 7
Complete Blood Count in Controls after the walking test: White blood cells
White blood cells will be measured in thousands/µL
Measured: Day 0
Complete Blood Count in Controls after the walking test: White blood cells
White blood cells will be measured in thousands/µL
Measured: Day 7
Complete Blood Count in Patients before the walking test: White blood cells
White blood cells will be measured in thousands/µL
Measured: Day 0
Complete Blood Count in Patients before the walking test: White blood cells
White blood cells will be measured in thousands/µL
Measured: Day 7
Complete Blood Count in Patients after the walking test: White blood cells
White blood cells will be measured in thousands/µL
Measured: Day 0
Complete Blood Count in Patients after the walking test: White blood cells
White blood cells will be measured in thousands/µL
Measured: Day 7
Complete Blood Count in Controls before the walking test: Red blood cells
Red blood cells will be measured in millions per cubic millimeter
Measured: Day 0
Complete Blood Count in Controls before the walking test: Red blood cells
Red blood cells will be measured in millions per cubic millimeter
Measured: Day 7
Complete Blood Count in Patients before the walking test: Red blood cells
Red blood cells will be measured in millions per cubic millimeter
Measured: Day 0
Complete Blood Count in Patients before the walking test: Red blood cells
Red blood cells will be measured in millions per cubic millimeter
Measured: Day 7
Complete Blood Count in Controls after the walking test: Red blood cells
Red blood cells will be measured in millions per cubic millimeter
Measured: Day 0
Complete Blood Count in Controls after the walking test: Red blood cells
Red blood cells will be measured in millions per cubic millimeter
Measured: Day 7
Complete Blood Count in Patients after the walking test: Red blood cells
Red blood cells will be measured in millions per cubic millimeter
Measured: Day 0
Complete Blood Count in Patients after the walking test: Red blood cells
Red blood cells will be measured in millions per cubic millimeter
Measured: Day 7
Complete Blood Count in Controls before the walking test:Hemaglobin
Hemaglobin will be measured in g/L
Measured: Day 0
Complete Blood Count in Controls before the walking test:Hemaglobin
Hemaglobin will be measured in g/L
Measured: Day 7
Complete Blood Count in Patients before the walking test:Hemaglobin
Hemaglobin will be measured in g/L
Measured: Day 0
Complete Blood Count in Patients before the walking test:Hemaglobin
Hemaglobin will be measured in g/L
Measured: Day 7
Complete Blood Count in Controls after the walking test: Hemaglobin
Hemaglobin will be measured in g/L
Measured: Day 0
Complete Blood Count in Controls after the walking test: Hemaglobin
Hemaglobin will be measured in g/L
Measured: Day 7
Complete Blood Count in Patients after the walking test: Hemaglobin
Hemaglobin will be measured in g/L
Measured: Day 0
Complete Blood Count in Patients after the walking test: Hemaglobin
Hemaglobin will be measured in g/L
Measured: Day 7
Complete Blood Count in Controls before the walking test: Hematocrite
Hematrocrite will be measured in L/L
Measured: Day 0
Complete Blood Count in Controls before the walking test: Hematocrite
Hematrocrite will be measured in L/L
Measured: Day 7
Complete Blood Count in Patients before the walking test: Hematocrite
Hematrocrite will be measured in L/L
Measured: Day 0
Complete Blood Count in Patients before the walking test: Hematocrite
Hematrocrite will be measured in L/L
Measured: Day 7
Complete Blood Count in Controls after the walking test: Hematocrite
Hematrocrite will be measured in L/L
Measured: Day 0
Complete Blood Count in Controls after the walking test: Hematocrite
Hematrocrite will be measured in L/L
Measured: Day 7
Complete Blood Count in Patients after the walking test: Hematocrite
Hematrocrite will be measured in L/L
Measured: Day 0
Complete Blood Count in Patients after the walking test: Hematocrite
Hematrocrite will be measured in L/L
Measured: Day 7
Complete Blood Count in Controls before the walking test: mean corpuscular volume
Mean corpuscular volume will be measured in fL
Measured: Day 0
Complete Blood Count in Controls before the walking test: mean corpuscular volume
Mean corpuscular volume will be measured in fL
Measured: Day 7
Complete Blood Count in Patients before the walking test: mean corpuscular volume
Mean corpuscular volume will be measured in fL
Measured: Day 0
Complete Blood Count in Patients before the walking test: mean corpuscular volume
Mean corpuscular volume will be measured in fL
Measured: Day 7
Complete Blood Count in Controls after the walking test: mean corpuscular volume
Mean corpuscular volume will be measured in fL
Measured: Day 0
Complete Blood Count in Controls after the walking test: mean corpuscular volume
Mean corpuscular volume will be measured in fL
Measured: Day 7
Complete Blood Count in Patients after the walking test: mean corpuscular volume
Mean corpuscular volume will be measured in fL
Measured: Day 0
Complete Blood Count in Patients after the walking test: mean corpuscular volume
Mean corpuscular volume will be measured in fL
Measured: Day 7
Complete Blood Count in Controls before the walking test: mean corpuscular hemoglobin
Mean Corpuscular Hemoglobin will be measured in pg
Measured: Day 0
Complete Blood Count in Controls before the walking test: mean corpuscular hemoglobin
Mean Corpuscular Hemoglobin will be measured in pg
Measured: Day 7
Complete Blood Count in Patients before the walking test: mean corpuscular hemoglobin
Mean Corpuscular Hemoglobin will be measured in pg
Measured: Day 0
Complete Blood Count in Patients before the walking test: mean corpuscular hemoglobin
Mean Corpuscular Hemoglobin will be measured in pg
Measured: Day 7
Complete Blood Count in Controls after the walking test: Mean corpuscular hemoglobin
Mean Corpuscular Hemoglobin will be measured in pg
Measured: Day 0
Complete Blood Count in Controls after the walking test: Mean corpuscular hemoglobin
Mean Corpuscular Hemoglobin will be measured in pg
Measured: Day 7
Complete Blood Count in Patients after the walking test: Mean corpuscular hemoglobin
Mean Corpuscular Hemoglobin will be measured in pg
Measured: Day 0
Complete Blood Count in Patients after the walking test: Mean corpuscular hemoglobin
Mean Corpuscular Hemoglobin will be measured in pg
Measured: Day 7
Complete Blood Count in Controls before the walking test: Mean corpuscular hemoglobin concentration
Mean Corpuscular Hemoglobin Concentration will be measured in g/L
Measured: Day 0
Complete Blood Count in Controls before the walking test: Mean corpuscular hemoglobin concentration
Mean Corpuscular Hemoglobin Concentration will be measured in g/L
Measured: Day 7
Complete Blood Count in Patients before the walking test: Mean corpuscular hemoglobin concentration
Mean Corpuscular Hemoglobin Concentration will be measured in g/L
Measured: Day 0
Complete Blood Count in Patients before the walking test: Mean corpuscular hemoglobin concentration
Mean Corpuscular Hemoglobin Concentration will be measured in g/L
Measured: Day 7
Complete Blood Count in Controls after the walking test: Mean corpuscular hemoglobin concentration
Mean Corpuscular Hemoglobin Concentration will be measured in g/L
Measured: Day 0
Complete Blood Count in Controls after the walking test: Mean corpuscular hemoglobin concentration
Mean Corpuscular Hemoglobin Concentration will be measured in g/L
Measured: Day 7
Complete Blood Count in Patients after the walking test: Mean corpuscular hemoglobin concentration
Mean Corpuscular Hemoglobin Concentration will be measured in g/L
Measured: Day 0
Complete Blood Count in Patients after the walking test: Mean corpuscular hemoglobin concentration
Mean Corpuscular Hemoglobin Concentration will be measured in g/L
Measured: Day 7
Complete Blood Count in Controls before the walking test: red cell distribution width
Red cell distribution width will be measured as %
Measured: Day 0
Complete Blood Count in Controls before the walking test: red cell distribution width
Red cell distribution width will be measured as %
Measured: Day 7
Complete Blood Count in Patients before the walking test: red cell distribution width
Red cell distribution width will be measured as %
Measured: Day 0
Complete Blood Count in Patients before the walking test: red cell distribution width
Red cell distribution width will be measured as %
Measured: Day 7
Complete Blood Count in Controls after the walking test: red cell distribution width
Red cell distribution width will be measured as %
Measured: Day 0
Complete Blood Count in Controls after the walking test: red cell distribution width
Red cell distribution width will be measured as %
Measured: Day 7
Complete Blood Count in Patients after the walking test: red cell distribution width
Red cell distribution width will be measured as %
Measured: Day 0
Complete Blood Count in Patients after the walking test: red cell distribution width
Red cell distribution width will be measured as %
Measured: Day 7
Complete Blood Count in Controls before the walking test: Platelets
Platelets will be measured in thousands/µL
Measured: Day 0
Complete Blood Count in Controls before the walking test: Platelets
Platelets will be measured in thousands/µL
Measured: Day 7
Complete Blood Count in Patients before the walking test: Platelets
Platelets will be measured in thousands/µL
Measured: Day 0
Complete Blood Count in Patients before the walking test: Platelets
Platelets will be measured in thousands/µL
Measured: Day 7
Complete Blood Count in Controls after the walking test: Platelets
Platelets will be measured in thousands/µL
Measured: Day 0
Complete Blood Count in Controls after the walking test: Platelets
Platelets will be measured in thousands/µL
Measured: Day 7
Complete Blood Count in Patients after the walking test: Platelets
Platelets will be measured in thousands/µL
Measured: Day 0
Complete Blood Count in Patients after the walking test: Platelets
Platelets will be measured in thousands/µL
Measured: Day 7
Complete Blood Count in Controls before the walking test: Neutrophils
Neutrophils will be measured in thousands/µL
Measured: Day 0
Complete Blood Count in Controls before the walking test: Neutrophils
Neutrophils will be measured in thousands/µL
Measured: Day 7
Complete Blood Count in Patients before the walking test: Neutrophils
Neutrophils will be measured in thousands/µL
Measured: Day 0
Complete Blood Count in Patients before the walking test: Neutrophils
Neutrophils will be measured in thousands/µL
Measured: Day 7
Complete Blood Count in Controls after the walking test: Neutrophils
Neutrophils will be measured in thousands/µL
Measured: Day 0
Complete Blood Count in Controls after the walking test: Neutrophils
Neutrophils will be measured in thousands/µL
Measured: Day 7
Complete Blood Count in Patients after the walking test: Neutrophils
Neutrophils will be measured in thousands/µL
Measured: Day 0
Complete Blood Count in Patients after the walking test: Neutrophils
Neutrophils will be measured in thousands/µL
Measured: Day 7
Complete Blood Count in Controls before the walking test: Lymphocytes
Lymphocytes will be measured in thousands/µL
Measured: Day 0
Complete Blood Count in Controls before the walking test: Lymphocytes
Lymphocytes will be measured in thousands/µL
Measured: Day 7
Complete Blood Count in Patients before the walking test: Lymphocytes
Lymphocytes will be measured in thousands/µL
Measured: Day 0
Complete Blood Count in Patients before the walking test: Lymphocytes
Lymphocytes will be measured in thousands/µL
Measured: Day 7
Complete Blood Count in Controls after the walking test: Lymphocytes
Lymphocytes will be measured in thousands/µL
Measured: Day 0
Complete Blood Count in Controls after the walking test: Lymphocytes
Lymphocytes will be measured in thousands/µL
Measured: Day 7
Complete Blood Count in Patients after the walking test: Lymphocytes
Lymphocytes will be measured in thousands/µL
Measured: Day 0
Complete Blood Count in Patients after the walking test: Lymphocytes
Lymphocytes will be measured in thousands/µL
Measured: Day 7
Complete Blood Count in Controls before the walking test: Monocytes
Monocytes will be measured in thousands/µL
Measured: Day 0
Complete Blood Count in Controls before the walking test: Monocytes
Monocytes will be measured in thousands/µL
Measured: Day 7
Complete Blood Count in Patients before the walking test: Monocytes
Monocytes will be measured in thousands/µL
Measured: Day 0
Complete Blood Count in Patients before the walking test: Monocytes
Monocytes will be measured in thousands/µL
Measured: Day 7
Complete Blood Count in Controls after the walking test: Monocytes
Monocytes will be measured in thousands/µL
Measured: Day 0
Complete Blood Count in Controls after the walking test: Monocytes
Monocytes will be measured in thousands/µL
Measured: Day 7
Complete Blood Count in Patients after the walking test: Monocytes
Monocytes will be measured in thousands/µL
Measured: Day 0
Complete Blood Count in Patients after the walking test: Monocytes
Monocytes will be measured in thousands/µL
Measured: Day 7
Complete Blood Count in Controls before the walking test: Eosinophils
Eosinophils will be measured in hundreds/µL
Measured: Day 0
Complete Blood Count in Controls before the walking test: Eosinophils
Eosinophils will be measured in hundreds/µL
Measured: Day 7
Complete Blood Count in Patients before the walking test: Eosinophils
Eosinophils will be measured in hundreds/µL
Measured: Day 0
Complete Blood Count in Patients before the walking test: Eosinophils
Eosinophils will be measured in hundreds/µL
Measured: Day 7
Complete Blood Count in Controls after the walking test: Eosinophils
Eosinophils will be measured in hundreds/µL
Measured: Day 0
Complete Blood Count in Controls after the walking test: Eosinophils
Eosinophils will be measured in hundreds/µL
Measured: Day 7
Complete Blood Count in Patients after the walking test: Eosinophils
Eosinophils will be measured in hundreds/µL
Measured: Day 0
Complete Blood Count in Patients after the walking test: Eosinophils
Eosinophils will be measured in hundreds/µL
Measured: Day 7
Complete Blood Count in Controls before the walking test: Basophils
Basophils will be measured in thousands/µL
Measured: Day 0
Complete Blood Count in Controls before the walking test: Basophils
Basophils will be measured in thousands/µL
Measured: Day 7
Complete Blood Count in Patients before the walking test: Basophils
Basophils will be measured in thousands/µL
Measured: Day 0
Complete Blood Count in Patients before the walking test: Basophils
Basophils will be measured in thousands/µL
Measured: Day 7
Complete Blood Count in Controls after the walking test: Basophils
Basophils will be measured in thousands/µL
Measured: Day 0
Complete Blood Count in Controls after the walking test: Basophils
Basophils will be measured in thousands/µL
Measured: Day 7
Complete Blood Count in Patients after the walking test: Basophils
Basophils will be measured in thousands/µL
Measured: Day 0
Complete Blood Count in Patients after the walking test: Basophils
Basophils will be measured in thousands/µL
Measured: Day 7
NETosis markers in Controls before the walking test
Fluorescence signal intensity of neutrophils will be measured on a SYSMEX automat
Measured: Day 0
NETosis markers in Controls after the walking test
Fluorescence signal intensity of neutrophils will be measured on a SYSMEX automat
Measured: Day 0
NETosis markers in Patients before the walking test
Fluorescence signal intensity of neutrophils will be measured on a SYSMEX automat
Measured: Day 7
NETosis markers in Patients after the walking test
Fluorescence signal intensity of neutrophils will be measured on a SYSMEX automat
Measured: Day 7
NETosis markers in Controls before the walking test: reacting monocytes
The percentage of reacting monocytes will be measured on a SYSMEX automat
Measured: Day 0
NETosis markers in Controls after the walking test: reacting monocytes
The percentage of reacting monocytes will be measured on a SYSMEX automat
Measured: Day 0
NETosis markers in Controls before the walking test: reacting monocytes
The percentage of reacting monocytes will be measured on a SYSMEX automat
Measured: Day 7
NETosis markers in Controls after the walking test: reacting monocytes
The percentage of reacting monocytes will be measured on a SYSMEX automat
Measured: Day 7
NETosis markers in Controls before the walking test: reacting lymphocytes
The percentage of reacting lymphocytes will be measured on a SYSMEX automat
Measured: Day 0
NETosis markers in Controls after the walking test: reacting lymphocytes
The percentage of reacting lymphocytes will be measured on a SYSMEX automat
Measured: Day 0
NETosis markers in Patients before the walking test: reacting lymphocytes
The percentage of reacting lymphocytes will be measured on a SYSMEX automat
Measured: Day 7
NETosis markers in Patients after the walking test: reacting lymphocytes
The percentage of reacting lymphocytes will be measured on a SYSMEX automat
Measured: Day 7
NETosis markers in Controls before the walking test:
The percentage of reacting lymphocytes will be measured on a SYSMEX automat
Measured: Day 0
NETosis markers in Controls after the walking test: circulating citrulinated histone H3
The percentage of circulating citrulinated histone H3 will be measured on a SYSMEX automat
Measured: Day 0
NETosis markers in Patients before the walking test: circulating citrulinated histone H3
The percentage of circulating citrulinated histone H3 will be measured on a SYSMEX automat
Measured: Day 7
NETosis markers in Patients after the walking test: circulating citrulinated histone H3
The percentage of circulating citrulinated histone H3 will be measured on a SYSMEX automat
Measured: Day 7
Coagulation factors in Controls before the walking test: fibrinogen
Fibrinogen will be measured in g/L
Measured: Day 0
Coagulation factors in Controls before the walking test
Coagulation factors XI, IX, VIII, VII, V, X and II will be measured in International Units
Measured: Day 0
Coagulation factors in Controls after the walking test: fibrinogen
Fibrinogen will be measured in g/L
Measured: Day 0
Coagulation factors in Controls after the walking test
Coagulation factors XI, IX, VIII, VII, V, X and II will be measured in International Units
Measured: Day 0
Coagulation factors in Patients before the walking test: fibrinogen
Fibrinogen will be measured in g/L
Measured: Day 7
Coagulation factors in Patients before the walking test
Coagulation factors XI, IX, VIII, VII, V, X and II will be measured in International Units
Measured: Day 7
Coagulation factors in Patients after the walking test: fibrinogen
Fibrinogen will be measured in g/L
Measured: Day 7
Coagulation factors in Patients after the walking test
Coagulation factors XI, IX, VIII, VII, V, X and II will be measured in International Units
Measured: Day 7
Indicators of fibrinoformation in Controls before the walking test: circulating fibrin monomers
Circulating fibrin monomers will be measured in fibrinogen equivalent units
Measured: Day 0
Indicators of fibrinoformation in Controls after the walking test: circulating fibrin monomers
Circulating fibrin monomers will be measured in fibrinogen equivalent units
Measured: Day 0
Indicators of fibrinoformation in Controls before the walking test: circulating fibrin monomers
Circulating fibrin monomers will be measured in fibrinogen equivalent units
Measured: Day 7
Indicators of fibrinoformation in Controls after the walking test: circulating fibrin monomers
Circulating fibrin monomers will be measured in fibrinogen equivalent units
Measured: Day 7
Indicators of fibrinoformation in Patients before the walking test: circulating fibrin monomers
Circulating fibrin monomers will be measured in fibrinogen equivalent units
Measured: Day 0
Indicators of fibrinoformation in Patients after the walking test: circulating fibrin monomers
Circulating fibrin monomers will be measured in fibrinogen equivalent units
Measured: Day 0
Indicators of fibrinoformation in Patients before the walking test: circulating fibrin monomers
Circulating fibrin monomers will be measured in fibrinogen equivalent units
Measured: Day 7
Indicators of fibrinoformation in Patients after the walking test: circulating fibrin monomers
Circulating fibrin monomers will be measured in fibrinogen equivalent units
Measured: Day 7
Indicators of fibrinoformation in Controls before the walking test: D-dimers
D-dimers will be measured in DDUs
Measured: Day 0
Indicators of fibrinoformation in Controls after the walking test: D-dimers
D-dimers will be measured in DDUs
Measured: Day 0
Indicators of fibrinoformation in Patients before the walking test: D-dimers
D-dimers will be measured in DDUs
Measured: Day 0
Indicators of fibrinoformation in Patients after the walking test: D-dimers
D-dimers will be measured in DDUs
Measured: Day 0
Indicators of fibrinoformation in Controls before the walking test: D-dimers
D-dimers will be measured in DDUs
Measured: Day 7
Indicators of fibrinoformation in Controls after the walking test: D-dimers
D-dimers will be measured in DDUs
Measured: Day 7
Indicators of fibrinoformation in Patients before the walking test: D-dimers
D-dimers will be measured in DDUs
Measured: Day 7
Indicators of fibrinoformation in Patients after the walking test: D-dimers
D-dimers will be measured in DDUs
Measured: Day 7
Markers of fibrinolysis in Controls before the walking test : Euglobulin lysis time
Euglobulin lysis time will be measured in hours
Measured: Day 0
Markers of fibrinolysis in Controls after the walking test : Euglobulin lysis time
Euglobulin lysis time will be measured in hours
Measured: Day 0
Markers of fibrinolysis in Patients before the walking test : Euglobulin lysis time
Euglobulin lysis time will be measured in hours
Measured: Day 0
Markers of fibrinolysis in Patients after the walking test : Euglobulin lysis time
Euglobulin lysis time will be measured in hours
Measured: Day 0
Markers of fibrinolysis in Controls before the walking test : Euglobulin lysis time
Euglobulin lysis time will be measured in hours
Measured: Day 7
Markers of fibrinolysis in Controls after the walking test : Euglobulin lysis time
Euglobulin lysis time will be measured in hours
Measured: Day 7
Markers of fibrinolysis in Patients before the walking test : Euglobulin lysis time
Euglobulin lysis time will be measured in hours
Measured: Day 7
Markers of fibrinolysis in Patients after the walking test : Euglobulin lysis time
Euglobulin lysis time will be measured in hours
Measured: Day 7
Markers of Endothelial function in Controls before the walking test: Willebrand factor
Willebrand factor will be measured as a %
Measured: Day 0
Markers of Endothelial function in Controls after the walking test: Willebrand factor
Willebrand factor will be measured as a %
Measured: Day 0
Markers of Endothelial function in Patients before the walking test: Willebrand factor
Willebrand factor will be measured as a %
Measured: Day 0
Markers of Endothelial function in Patients after the walking test: Willebrand factor
Willebrand factor will be measured as a %
Measured: Day 0
Markers of Endothelial function in Controls before the walking test: Willebrand factor
Willebrand factor will be measured as a %
Measured: Day 7
Markers of Endothelial function in Controls after the walking test: Willebrand factor
Willebrand factor will be measured as a %
Measured: Day 7
Markers of Endothelial function in Patients before the walking test: Willebrand factor
Willebrand factor will be measured as a %
Measured: Day 7
Markers of Endothelial function in Patients after the walking test: Willebrand factor
Willebrand factor will be measured as a%
Measured: Day 7
Markers of Endothelial function in Controls before the walking test: ristocetin cofactor
Ristocetin cofactor will be measured as a %
Measured: Day 0
Markers of Endothelial function in Controls after the walking test: ristocetin cofactor
Ristocetin cofactor will be measured as a %
Measured: Day 0
Markers of Endothelial function in Patients before the walking test: ristocetin cofactor
Ristocetin cofactor will be measured as a %
Measured: Day 0
Markers of Endothelial function in Patients after the walking test: ristocetin cofactor
Ristocetin cofactor will be measured as a %
Measured: Day 0
Markers of Endothelial function in Controls before the walking test: ristocetin cofactor
Ristocetin cofactor will be measured as a %
Measured: Day 7
Markers of Endothelial function in Controls after the walking test: ristocetin cofactor
Ristocetin cofactor will be measured as a %
Measured: Day 7
Markers of Endothelial function in Patients before the walking test: ristocetin cofactor
Ristocetin cofactor will be measured as a %
Measured: Day 7
Markers of Endothelial function in Patients after the walking test: ristocetin cofactor
Ristocetin cofactor will be measured as a %
Measured: Day 7
Markers of Endothelial function in Controls before the walking test: ADAMTS-13 activity
ADAMTS-13 activity will be measured as a %
Measured: Day 0
Markers of Endothelial function in Controls after the walking test: ADAMTS-13 activity
ADAMTS-13 activity will be measured as a %
Measured: Day 0
Markers of Endothelial function in Patients before the walking test: ADAMTS-13 activity
ADAMTS-13 activity will be measured as a %
Measured: Day 0
Markers of Endothelial function in Patients after the walking test: ADAMTS-13 activity
ADAMTS-13 activity will be measured as a %
Measured: Day 0
Markers of Endothelial function in Controls before the walking test: ADAMTS-13 activity
ADAMTS-13 activity will be measured as a %
Measured: Day 7
Markers of Endothelial function in Controls after the walking test: ADAMTS-13 activity
ADAMTS-13 activity will be measured as a %
Measured: Day 7
Markers of Endothelial function in Patients before the walking test: ADAMTS-13 activity
ADAMTS-13 activity will be measured as a %
Measured: Day 7
Markers of Endothelial function in Patients after the walking test: ADAMTS-13 activity
ADAMTS-13 activity will be measured as a %
Measured: Day 7
Markers of Endothelial function in Controls before the walking test: soluble thrombomodulin
Soluble thrombomodulin will be measured as a %
Measured: Day 0
Markers of Endothelial function in Controls after the walking test: soluble thrombomodulin
Soluble thrombomodulin will be measured as a %
Measured: Day 0
Markers of Endothelial function in Patients before the walking test: soluble thrombomodulin
Soluble thrombomodulin will be measured as a %
Measured: Day 0
Markers of Endothelial function in Patients after the walking test: soluble thrombomodulin
Soluble thrombomodulin will be measured as a %
Measured: Day 0
Markers of Endothelial function in Controls before the walking test: soluble thrombomodulin
Soluble thrombomodulin will be measured as a %
Measured: Day 7
Markers of Endothelial function in Controls after the walking test: soluble thrombomodulin
Soluble thrombomodulin will be measured as a %
Measured: Day 7
Markers of Endothelial function in Patients before the walking test: soluble thrombomodulin
Soluble thrombomodulin will be measured as a %
Measured: Day 7
Markers of Endothelial function in Patients after the walking test: soluble thrombomodulin
Soluble thrombomodulin will be measured as a %
Measured: Day 7
Markers of Endothelial function in Controls before the walking test: soluble endothelial protein C receptor
Soluble endothelial protein C receptor will be measured as a %
Measured: Day 0
Markers of Endothelial function in Controls after the walking test: soluble endothelial protein C receptor
Soluble endothelial protein C receptor will be measured as a %
Measured: Day 0
Markers of Endothelial function in Patients before the walking test: soluble endothelial protein C receptor
Soluble endothelial protein C receptor will be measured as a %
Measured: Day 0
Markers of Endothelial function in Patients after the walking test: soluble endothelial protein C receptor
Soluble endothelial protein C receptor will be measured as a %
Measured: Day 0
Markers of Endothelial function in Controls before the walking test: soluble endothelial protein C receptor
Soluble endothelial protein C receptor will be measured as a %
Measured: Day 7
Markers of Endothelial function in Controls after the walking test: soluble endothelial protein C receptor
Soluble endothelial protein C receptor will be measured as a %
Measured: Day 7
Markers of Endothelial function in Patients before the walking test: soluble endothelial protein C receptor
Soluble thrombomodulin will be measured as a %
Measured: Day 7
Markers of Endothelial function in Patients after the walking test: soluble endothelial protein C receptor
Soluble thrombomodulin will be measured as a %
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start11 Feb 2025
- Primary completion1 Apr 2030 (estimated)
- Study completion1 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a single-center, prospective, cross-sectional, proof-of-concept study,
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonia PEREZ MARTIN, Prof., Principal investigator, Nîmes University HospitalStéphane FAURE, Principal investigator, Nîmes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06418633
- Sponsor's protocol ID
- NIMAO 2023 1
- Acronym
- FAST&THROMBIN
- Status last verified
- Jun 2026
- First submitted
- 28 Apr 2024
- Last updated
- 22 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gris JC, Guillotin F, Dos Santos TP, Chea M, Loubet P, Laureillard D, Sotto A, Muller L, Barbar SD, Roger C, Lefrant JY, Jung B, Klouche K, Mura T, Quere I, Perez-Martin A. Prognostic value of an automated thrombin generation assay in COVID-19 patients entering hospital: A multicentric, prospective observational study. Thromb Res. 2023 Feb;222:85-95. doi: 10.1016/j.thromres.2022.12.019. Epub 2023 Jan 2.
PubMed 36608393
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Variations in the Hemostatic System Induced by a Standardized Walking Test: Controls vs. Cases With a History of Non-anticoagulated Venous Thromboembolic Disease
- ClinicalTrials.gov ID
- NCT06418633
- Acronym / sponsor ID
- FAST&THROMBIN / NIMAO 2023 1
- Conditions
- Venous Thromboembolism
- Keywords
- Physical exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 11 Feb 2025 (actual)
- Primary completion
- 1 Apr 2030 (estimated)
- Study completion
- 1 Apr 2030 (estimated)
- First posted
- 17 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Two groups of patients will be compared: One group of patients with a history of venous thromboembolic disease and one group without. Both groups will be subjected to a walking test and with electrocardiogram measurements and blood tests.
Detailed description
Induced venous thromboembolism is a situation in which venous thromboembolic disease is triggered by an acute event that activates hemostasis: surgery, trauma, infectious or inflammatory outbreak, etc., a situation in which the risk of spontaneous recurrence, in the absence of a new provoking circumstance, is low, leading to the suggestion, not of long-term thromboprophylaxis, but simply the transient prevention of an event when there is a new clinical event likely to activate hemostasis. One such event is acute physical exertion.
Indeed, cohort studies seem to show that regular physical activity is associated with a low incidence of venous thromboembolism. Trained individuals have an endogenous thrombotic potential, assessed by the thrombin TGT test, lower than that of sedentary controls. A 3-month regimen of daily endurance exercise reduces thrombin generation controls and optimizes the fibrinolytic system. Repetitive exercise is accompanied by a depletion of exercise-induced platelet activation. However, several cases of venous thromboembolism have been reported in high-level athletes without usual risk factors and acute high-intensity rowing induces an acute increase in thrombin generation immediately after exercise, which disappears within 16 to 24 hours. The relationship between the level of physical activity and the risk of VTE could be a U-shaped relation, with an increasing risk of event in intense acute practice.
However, no data exists on the hemostatic impact of an acute session of physical activity in patients with a history of venous thromboembolism. Thus, the hypothesis is that exercise-induced response of hemostasis differ in patients with an history of provoked VTE compared to subjects without a history of venous thromboembolism.
This is a proof-of-concept, pathophysiological, single-center, cross-sectional, prospective comparison study of a group of patients with a personal history of induced Venous thromboembolism to a group of sex- and age- and sex-matched controls (+/- 5 years).
- Type of clinical study: Stress test-induced variations in parameters describing the results of the thrombin generation test (Thromboscreen®) in a group of Patients (Cases) will be compared with those obtained in a group of Control subjects (Controls) with a ratio 1:1.
The Patients group comprises 47 patients with a personal history of induced venous thromboembolism, the last event dating back to more than 6 months, whose clinical phenotype did not justify long-term antithrombotic drug prophylaxis.The Control group comprises 47 patients with no personal history of venous thromboembolism and no family history of venous thromboembolism in first-degree relatives.
The study intervention consists of an hour-long walking test and two blood tests in both groups for all participants (Controls and Patients).
- Intra-individual reproducibility will be analyzed in 20 subjects (10 patients and 10 controls) who will take the walking test twice on two separate days.
Patients will be selected during a venous thromboembolism follow-up consultation by a physician from either department (Vascular Medicine Consultation or Biological Hematology and Consultations).Inclusion and non-inclusion criteria will be checked, and the study will be explained to participants (patients and controls).Patients and controls will be systematically asked to take part in the variability analysis on a voluntary basis, until 10 subjects per group have agreed to carry out the second test.
The walking test is performed in the morning, 2 hours after a standard breakfast, on a treadmill. It will be preceded by a clinical examination, a resting 12-lead electrocardiogram and a brachial pressure measurement. After a 3-minute warm-up and "habituation" period (walking speed 2.5 km per hour with no incline), the speed and incline will be gradually increased until a target heart rate close to the theoretical ventilatory threshold, and of the order of 70% of the theoretical maximum value (evaluated by Astrand's formula: 220-age), so as to maintain aerobic exercise conditions of moderate intensity, enabling prolonged effort to be maintained. Blood samples will be taken from each participant whilst at rest, before undergoing the 60-minute walking test, in a sitting position, and just after the exercise test.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This is a single-center, prospective, cross-sectional, proof-of-concept study,
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: 60-minute walking test, Diagnostic Test: Static blood test, Diagnostic Test: Post-effort blood test, Other: Electrocardiogram, Other: Blood pressure monitoringSubjects with neither a personal history nor family history of venous thromboembolism in first-degree relatives. |
| Patients | Active comparator | Other: 60-minute walking test, Diagnostic Test: Static blood test, Diagnostic Test: Post-effort blood test, Other: Electrocardiogram, Other: Blood pressure monitoringPatients with a personal history of induced venous thromboembolism, the last attack dating back to more than 6 months, whose clinical phenotype did not justify long-term antithrombotic drug prophylaxis |
| Individual reproducibility" subgroup: controls | Active comparator | Other: 60-minute walking test, Diagnostic Test: Static blood test, Diagnostic Test: Post-effort blood test, Other: Electrocardiogram, Other: Blood pressure monitoring10 subjects with neither a personal history nor family history of venous thromboembolism in first-degree relatives who have accepted to re-do the test one week later. |
| Individual reproducibility" subgroup: patients | Active comparator | Other: 60-minute walking test, Diagnostic Test: Static blood test, Diagnostic Test: Post-effort blood test, Other: Electrocardiogram, Other: Blood pressure monitoring10 patients with a history of induced venous thromboembolism, the last attack dating back to more than 6 months, whose clinical phenotype did not justify long-term antithrombotic drug prophylaxis, who have accepted to re-do the test one week later. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patients who have given written informed consent.
- Patients who are affiliated to or beneficiaries of a social security scheme.
- Patients with a personal history of provoked venous thromboembolism, venous thrombosis and/or pulmonary embolism, with the last attack dating back to more than 6 months, and whose clinical phenotype did not justify long-term antithrombotic drug prophylaxis.
- Definition of provoked venous thromboembolism : The clinical criteria used to classify venous thromboembolism as provoked are :
- First year of combined oestrogen-progestogen oral contraception, or contraception using an oestrogen-impregnated vaginal ring or transcutaneous synthetic oestrogen patch.
Key exclusion criteria (9 listed)
- Patients who are physically unable to perform the 60-minute walking test, for any reason, in particular cardiovascular contraindications to exercise (recent acute coronary syndrome unstable angina, rhythm disorders, tight aortic stenosis, cardiac heart failure, acute myocarditis, pericarditis or endocarditis endocarditis, poorly controlled hypertension, pre-stress blood pressure > 200/110 mmHg, recent stroke or transient ischemic attack).
- Patients on anticoagulant or antithrombotic treatment, ongoing or discontinued within the last month.
- Patients treated for pulmonary embolism who remain dyspneic after anticoagulant treatment and requiring a work-up for pulmonary hypertension.
- Last surgery dating back to less than 3 months.
- Known chronic morbidities: diabetes mellitus, chronic inflammatory or infectious disease, heart failure, renal insufficiency, hepatic insufficiency or arterial thrombosis dating back to less than 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 60-minute walking testTreadmill walking test in the morning, 2 hours after breakfast, following a clinical examination, resting 12-lead electrocardiogram and blood pressure measurement. After a 3-minute warm-up and walking of speed 2.5 km per hour, no incline, the speed and incline are gradually increased to reach a target heart rate close to the theoretical ventilatory threshold, around 70% of the theoretical maximum value (evaluated by Astrand's formula: 220-age), i.e. aerobic conditions of moderate intensity so that prolonged effort can be maintained. Test performed in presence of a physician trained in stress testing. Emergency cart and defibrillator available in the department. Intra-hospital vital emergency protocol in place, with resuscitation teams on standby. The cardiology department, in the same building, can be contacted in the event of a cardiological abnormality during the test or recovery. The test takes 60 minutes, including a 3-minute initial warm-up. | Other | Control group, Individual reproducibility" subgroup: controls, Individual reproducibility" subgroup: patients, Patients |
| Static blood test33.3 ml of blood will be taken from each participant whilst at rest, before undergoing the 60-minute walking test | Diagnostic test | Control group, Individual reproducibility" subgroup: controls, Individual reproducibility" subgroup: patients, Patients |
| Post-effort blood test33.3 ml of blood will be taken from each participant immediately after undergoing the 60-minute walking test. | Diagnostic test | Control group, Individual reproducibility" subgroup: controls, Individual reproducibility" subgroup: patients, Patients |
| ElectrocardiogramAn electrocardiogram will be carried out throughout the exercise period and during the first 30 minutes of recovery. | Other | Control group, Individual reproducibility" subgroup: controls, Individual reproducibility" subgroup: patients, Patients |
| Blood pressure monitoringBlood pressure will be monitored out throughout the exercise period and during the first 30 minutes of recovery. | Other | Control group, Individual reproducibility" subgroup: controls, Individual reproducibility" subgroup: patients, Patients |
Primary outcome
Thrombin generation dosage before effort in controls
Time frame: Day 0
The amount of thrombomodulin in the blood will be measured in nmol/L with the help of Thromboscreen(TM)
Thrombin generation dosage before effort in patients
Time frame: Day 0
The amount of thrombomodulin in the blood will be measured in nmol/L with the help of Thromboscreen(TM)
Thrombin generation dosage after effort in controls
Time frame: Day 0
The amount of thrombomodulin in the blood will be measured in nmol/L with the help of Thromboscreen(TM). The difference between measurements before and after effort will be measured in nM.min-1
Thrombin generation dosage after effort in patients
Time frame: Day 0
The amount of thrombomodulin in the blood will be measured in nmol/L with the help of Thromboscreen(TM). The difference between measurements before and after effort will be measured in nM.min-1
Thrombin generation dosage before effort in the "Individual reproducibility" subgroup: controls
Time frame: Day 7
The amount of thrombomodulin in the blood will be measured in nmol/L with the help of Thromboscreen(TM)
Thrombin generation dosage before effort in the "Individual reproducibility" subgroup: patients
Time frame: Day 7
The amount of thrombomodulin in the blood will be measured in nmol/L with the help of Thromboscreen(TM)
Thrombin generation dosage after effort in the "Individual reproducibility" subgroup: controls
Time frame: Day 7
The amount of thrombomodulin in the blood will be measured in nmol/L with the help of Thromboscreen(TM). The difference between measurements before and after effort will be measured in nM.min-1
Thrombin generation dosage after effort in the "Individual reproducibility" subgroup: patients
Time frame: Day 7
The amount of thrombomodulin in the blood will be measured in nmol/L with the help of Thromboscreen(TM). The difference between measurements before and after effort will be measured in nM.min-1
230 secondary outcomes
Distribution in the Control group
Time frame: Day 0
Distribution in the Patient group
Time frame: Day 0
Thromboscreen test in Controls in the absence of thrombomodulin : Latency time
Time frame: Day 0
Thromboscreen test in Controls in the absence of thrombomodulin : Thrombin peak intensity
Time frame: Day 0
Thromboscreen test in Controls in the absence of thrombomodulin : Time-to-peak thrombin
Time frame: Day 0
Thromboscreen test in Controls in the absence of thrombomodulin : Initial thrombin generation velocity
Time frame: Day 0
Thromboscreen test in Controls in the absence of thrombomodulin : Time to return to baseline
Time frame: Day 0
Thromboscreen test in Controls in the presence of thrombomodulin : Latency time
Time frame: Day 0
Thromboscreen test in Controls in the presence of thrombomodulin : Thrombin peak intensity
Time frame: Day 0
Thromboscreen test in Controls in the presence of thrombomodulin : Time-to-peak thrombin
Time frame: Day 0
Thromboscreen test in Controls in the presence of thrombomodulin : Initial thrombin generation velocity
Time frame: Day 0
Thromboscreen test in Controls in the presence of thrombomodulin : Time to return to baseline
Time frame: Day 0
Thromboscreen test in Patients in the absence of thrombomodulin : Latency time
Time frame: Day 0
Thromboscreen test in Patients in the absence of thrombomodulin : Thrombin peak intensity
Time frame: Day 0
Thromboscreen test in Patients in the absence of thrombomodulin : Time-to-peak thrombin
Time frame: Day 0
Thromboscreen test in Patients in the absence of thrombomodulin : Initial thrombin generation velocity
Time frame: Day 0
Thromboscreen test in Patients in the absence of thrombomodulin : Time to return to baseline
Time frame: Day 0
Thromboscreen test in Patients in the presence of thrombomodulin : Latency time
Time frame: Day 0
Thromboscreen test in Patients in the presence of thrombomodulin : Thrombin peak intensity
Time frame: Day 0
Thromboscreen test in Patients in the presence of thrombomodulin : Time-to-peak thrombin
Time frame: Day 0
Thromboscreen test in Patients in the presence of thrombomodulin : Initial thrombin generation velocity
Time frame: Day 0
Thromboscreen test in Patients in the presence of thrombomodulin : Time to return to baseline
Time frame: Day 0
Distribution of other parameters of the Thromboscreen test in Controls
Time frame: Day 0
Distribution of other parameters of the Thromboscreen test in Patients
Time frame: Day 0
Endogenous Thrombotic Potential in the presence of thrombomodulin in Controls
Time frame: Day 0
Endogenous Thrombotic Potential in the absence of thrombomodulin in Controls
Time frame: Day 0
Endogenous Thrombotic Potential in the presence of thrombomodulin in Patients
Time frame: Day 0
Endogenous Thrombotic Potential in the absence of thrombomodulin in Patients
Time frame: Day 0
Heterogeneity of Endogenous Thrombotic Potential in Controls
Time frame: Day 0
Heterogeneity of Endogenous Thrombotic Potential in Patients
Time frame: Day 0
Complete Blood Count in Controls before the walking test: White blood cells
Time frame: Day 0
Complete Blood Count in Controls before the walking test: White blood cells
Time frame: Day 7
Complete Blood Count in Controls after the walking test: White blood cells
Time frame: Day 0
Complete Blood Count in Controls after the walking test: White blood cells
Time frame: Day 7
Complete Blood Count in Patients before the walking test: White blood cells
Time frame: Day 0
Complete Blood Count in Patients before the walking test: White blood cells
Time frame: Day 7
Complete Blood Count in Patients after the walking test: White blood cells
Time frame: Day 0
Complete Blood Count in Patients after the walking test: White blood cells
Time frame: Day 7
Complete Blood Count in Controls before the walking test: Red blood cells
Time frame: Day 0
Complete Blood Count in Controls before the walking test: Red blood cells
Time frame: Day 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Background: PubMed 36608393Gris JC, Guillotin F, Dos Santos TP, Chea M, Loubet P, Laureillard D, Sotto A, Muller L, Barbar SD, Roger C, Lefrant JY, Jung B, Klouche K, Mura T, Quere I, Perez-Martin A. Prognostic value of an automated thrombin generation assay in COVID-19 patients entering hospital: A multicentric, prospective observational study. Thromb Res. 2023 Feb;222:85-95. doi: 10.1016/j.thromres.2022.12.019. Epub 2023 Jan 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Antonia PEREZ MARTIN, Prof. principal investigator
Nîmes University Hospital
Stéphane FAURE principal investigator
Nîmes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 60-minute walking test, Static blood test and Post-effort blood test in people with Venous Thromboembolism, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonia PEREZ MARTIN, Prof. (+334 66 68 33 13, antonia.perez.martin@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thrombin generation dosage before effort in controls (time frame: Day 0). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06418633, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.