COVID-19NCT04338932
COVID-19 and Deep Venous Thrombosis
An observational study of COVID-19 and Deep Vein Thrombosis (DVT)/Thrombophlebitis, run by Jessa Hospital at 1 site in Belgium.
Trial summary
The aim of this study is to investigate the prevalence and possible risk factors of the occurrence of a DVT in 12 intubated and mechanically ventilated COVID-19 patients admitted to the ICU at a single time point (29/03/2020). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Deep Vein Thrombosis (DVT)/Thrombophlebitis
- How many people
- 12 participants
- Where
- 1 siteBelgium
- Study dates
- 17 Apr 2020to 15 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 12 intubated and mechanically ventilated COVID-19 patients admitted to the ICU at a single time point (29/03/2020).
Who may be able to join
- 12 intubated and mechanically ventilated COVID-19 patients admitted to the ICU at a single time point (29/03/2020).
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COVID-19 and Deep Venous Thrombosis: a Cross-sectional Study
The aim of this study is to investigate the prevalence and possible risk factors of the occurrence of a DVT in 12 intubated and mechanically ventilated COVID-19 patients admitted to the ICU at a single time point (29/03/2020).
Read the detailed description
Patients admitted to the Intensive Care Unit (ICU) are known to be at risk for thrombo-embolic events. Virchow's triad describes the major risk factors in three categories: venous stasis, vessel injury and activation of blood coagulation. A prolonged mechanical ventilation together with the hemodynamic effects of this ventilation with a high positive and expiratory pressure (PEEP), the presence of central venous catheters, the immobilization of these patients and the presence of obesity or other comorbidities can attribute to the occurrence of a deep venous thrombosis (DVT) in patients admitted at ICU. The incidence of DVT during ICU stay has been reported between 5 and 15%.
On the 13th of March, the first COVID-19 patient was admitted at the ICU at the Jessa Hospital. Within a few days, the admissions at our COVID-19 unit grew exponential. In these difficult time, research concerning COVID-19 has been performed indicating the COVID-19 virus induces a hyper-inflammatory state. It has been suggested that systemic inflammation induces endothelial injury. This will activate the coagulation cascade and impair fibrinolysis with disruption of endothelial barrier, and loss of physiologic antithrombotic factors which may elevated the risk for DVTs significantly. Up to now, there is still no causal treatment for COVID-19. The current management of COVID-19 is mainly supportive i.e. a prolonged inflammatory status and a prolonged risk for VTE.
During the placement of a dialysis catheter in the femoral vein of one of the patients admitted in the ICU for COVID-19 at our hospital, a large deep vein thrombosis (DVT) proximal in both common femoral veins was noticed in a patient. Since there were no clinical signs of DVT present in this patient, every patient at the ICU unit at that moment was screened on the presence of DVTs. We found one or several deep vein thromboses in 8 out of 12 patients at 1 ICU unit. Since this was a unusual high incidence, we want to further investigate this prevalence and evaluate possible causes of these DVTs.
The aim of this study is to investigate the prevalence and possible risk factors of the occurrence of a DVT in 12 intubated and mechanically ventilated COVID-19 patients admitted to the ICU at a single time point (29/03/2020).
The endpoint of this cross-sectional study is to investigate the prevalence and identify possible risk factors of the occurrence of a DVT in these patients at the ICU.
These parameters are listed below and included parameters/values collected as a standard-of-care in our hospital:
- Demographics: i.e age, gender
- Comorbidities: smoking, hypertension, diabetes, cardiovascular disease, respiratory disease, malignancies, renal failure, liver failure, gastrointestinal disease, neurological conditions, mental state, other
- Symptoms at the time of admission to ICU: i.e fever, body temperature, dyspnoea, headache, diarrhea etc…
- Laboratory results of all standard parameters measured
- Treatment: antiviral agents, antibiotics, etc…
- Complications: shock, heart failure, sepsis, stroke, etc…
- Ventilation: method, PEEP, FiO2, ..
- Radiological findings: pneumonia, ground-glass opacity..
- Medical subject headings
- COVID-19, Venous Thrombosis
What is being measured
The primary outcome is the main question the study is designed to answer.
the prevalence of a DVT in patients at the ICU.
to investigate the prevalence of a DVT in patients at the ICU.
Measured: 1 day at ICU
Secondary outcomes (11)
Oxygen partial pressure and Carbon dioxide partial pressure levels in the blood
evaluate pO2 and pCO2 (mmHg) in patients with and without a DVT
Measured: 1 day at ICU
Potassium, Sodium, Calcium, Bicarbonate, Base excess, Lactate levels in the blood
evaluate Potassium, Sodium, Calcium, Bicarbonate, Base excess, Lactate levels (mmol/l) in patients with and without a DVT
Measured: 1 day at ICU
glucose, haemoglobin, ureum, creatinine, total bilirubin levels in the blood
evaluate glucose, haemoglobin, ureum, creatinine, total bilirubin levels (mg/dl) in patients with and without a DVT
Measured: 1 day at ICU
oxygen saturation, basophils, eosinophils, monocytes, neutrophils, haematocrit and prothrombine levels in the blood
evaluate oxygen saturation, basophils, eosinophils, monocytes, neutrophils, haematocrit and prothrombine levels in the blood (%) in patients with and without a DVT
Measured: 1 day at ICU
white blood cells, red blood cells and platelets in the blood
evaluate white blood cells (x 10*9/L), red blood cells (x 10*12/L) and platelets levels (x 109/L) in the blood in patients with and without a DVT
Measured: 1 day at ICU
PT (%)aPTT (sec)Fibrinogen (g/L)D-dimers (mg/L) PT (INR) (ratio) AST (U/L)ALT (U/L)Lactate dehydrogenase (U/L)Troponin T (ng/L)CRP (mg/L)Ferritin (mg/L)in the blood
evaluate PT (%)aPTT (sec)Fibrinogen (g/L)D-dimers (mg/L) PT (INR) (ratio) AST (U/L)ALT (U/L)Lactate dehydrogenase (U/L)Troponin T (ng/L)CRP (mg/L)Ferritin (mg/L) in the blood in patients with and without a DVT
Measured: 1 day at ICU
prevalence of co-morbidities
revalence of co morbidities such as Cardiovascular disease, n (%) Hypertension, n (%) Diabetes, n (%) Respiratory disease, n (%) Malignancy, n (%) Chronic renal disease, n (%) Chronic liver disease, n (%) Chronic bowel disease, n (%) Chronic nerve disease, n (%) Cerebrovascular disease, n (%) HIV/AIDS, n (%) Haematological disease, n (%) Obesity, n (%) Rheumatological disease, n (%) Dementia, n (%) in patients with and without a DVT admitted at the ICU in 1 day
Measured: 1 day at ICU
prevalence of vital signs at icu admission
prevalence of vital signs such Temperature (°C) Breathing rate (#/min) Systolic blood pressure (mmHg) Mean arterial blood pressure (mmHg) Heart rate (#/min) Glasgow Coma Scale in patients with and without a DVT
Measured: at ICU admission
prevalence of complications during icu stay
prevalance of complications such as ARDS Acute kidney failure Acute heart failure Septic shock Secondary infection Seizure Stroke Hyperglaecemia Hypoglaecemia during ICU stay in patients with and without DVT
Measured: from ICU admission to cross sectional moment (29/3/2020)
evaluation of treatment
evaluation of treatment such as Antiviral treatment Antibiotic treatment Antifungal treatment Corticosteroid treatment CRRT IVIg treatment Plaquenil treatment during ICU stay in patients with and without DVT
Measured: from ICU admission to cross sectional moment (29/3/2020)
evaluation of the oxygen therapy
evaluation of the oxygen therapy such as Invasive mechanical ventilation FiO2 (mmHg) PEEP Length of ventilationA ECMO Invasive mechanical ventilation + ECMO Vasopressor/inotropic support Neuromuscular blocking agents Prone ventilation in patients with and without DVT
Measured: from ICU admission to cross sectional moment (29/3/2020)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2020
- Study start17 Apr 2020
- Primary completion15 May 2020
- Study completion15 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jessa Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stessel Björn, Jessa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04338932
- Sponsor's protocol ID
- JessaH_COVID19_DVT
- Status last verified
- May 2020
- First submitted
- 7 Apr 2020
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 and Deep Venous Thrombosis: a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT04338932
- Acronym / sponsor ID
- JessaH_COVID19_DVT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Jessa HospitalUniversity, hospital or other
- Study start
- 17 Apr 2020 (actual)
- Primary completion
- 15 May 2020 (actual)
- Study completion
- 15 May 2020 (actual)
- First posted
- 8 Apr 2020 (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.
The aim of this study is to investigate the prevalence and possible risk factors of the occurrence of a DVT in 12 intubated and mechanically ventilated COVID-19 patients admitted to the ICU at a single time point (29/03/2020).
Detailed description
Patients admitted to the Intensive Care Unit (ICU) are known to be at risk for thrombo-embolic events. Virchow's triad describes the major risk factors in three categories: venous stasis, vessel injury and activation of blood coagulation. A prolonged mechanical ventilation together with the hemodynamic effects of this ventilation with a high positive and expiratory pressure (PEEP), the presence of central venous catheters, the immobilization of these patients and the presence of obesity or other comorbidities can attribute to the occurrence of a deep venous thrombosis (DVT) in patients admitted at ICU. The incidence of DVT during ICU stay has been reported between 5 and 15%.
On the 13th of March, the first COVID-19 patient was admitted at the ICU at the Jessa Hospital. Within a few days, the admissions at our COVID-19 unit grew exponential. In these difficult time, research concerning COVID-19 has been performed indicating the COVID-19 virus induces a hyper-inflammatory state. It has been suggested that systemic inflammation induces endothelial injury. This will activate the coagulation cascade and impair fibrinolysis with disruption of endothelial barrier, and loss of physiologic antithrombotic factors which may elevated the risk for DVTs significantly. Up to now, there is still no causal treatment for COVID-19. The current management of COVID-19 is mainly supportive i.e. a prolonged inflammatory status and a prolonged risk for VTE.
During the placement of a dialysis catheter in the femoral vein of one of the patients admitted in the ICU for COVID-19 at our hospital, a large deep vein thrombosis (DVT) proximal in both common femoral veins was noticed in a patient. Since there were no clinical signs of DVT present in this patient, every patient at the ICU unit at that moment was screened on the presence of DVTs. We found one or several deep vein thromboses in 8 out of 12 patients at 1 ICU unit. Since this was a unusual high incidence, we want to further investigate this prevalence and evaluate possible causes of these DVTs.
The aim of this study is to investigate the prevalence and possible risk factors of the occurrence of a DVT in 12 intubated and mechanically ventilated COVID-19 patients admitted to the ICU at a single time point (29/03/2020).
The endpoint of this cross-sectional study is to investigate the prevalence and identify possible risk factors of the occurrence of a DVT in these patients at the ICU.
These parameters are listed below and included parameters/values collected as a standard-of-care in our hospital:
- Demographics: i.e age, gender
- Comorbidities: smoking, hypertension, diabetes, cardiovascular disease, respiratory disease, malignancies, renal failure, liver failure, gastrointestinal disease, neurological conditions, mental state, other
- Symptoms at the time of admission to ICU: i.e fever, body temperature, dyspnoea, headache, diarrhea etc…
- Laboratory results of all standard parameters measured
- Treatment: antiviral agents, antibiotics, etc…
- Complications: shock, heart failure, sepsis, stroke, etc…
- Ventilation: method, PEEP, FiO2, ..
- Radiological findings: pneumonia, ground-glass opacity..
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 12 intubated and mechanically ventilated COVID-19 patients admitted to the ICU at a single time point (29/03/2020).
Key inclusion criteria (1 listed)
- 12 intubated and mechanically ventilated COVID-19 patients admitted to the ICU at a single time point (29/03/2020).
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the prevalence of a DVT in patients at the ICU.
Time frame: 1 day at ICU
to investigate the prevalence of a DVT in patients at the ICU.
11 secondary outcomes
Oxygen partial pressure and Carbon dioxide partial pressure levels in the blood
Time frame: 1 day at ICU
Potassium, Sodium, Calcium, Bicarbonate, Base excess, Lactate levels in the blood
Time frame: 1 day at ICU
glucose, haemoglobin, ureum, creatinine, total bilirubin levels in the blood
Time frame: 1 day at ICU
oxygen saturation, basophils, eosinophils, monocytes, neutrophils, haematocrit and prothrombine levels in the blood
Time frame: 1 day at ICU
white blood cells, red blood cells and platelets in the blood
Time frame: 1 day at ICU
PT (%)aPTT (sec)Fibrinogen (g/L)D-dimers (mg/L) PT (INR) (ratio) AST (U/L)ALT (U/L)Lactate dehydrogenase (U/L)Troponin T (ng/L)CRP (mg/L)Ferritin (mg/L)in the blood
Time frame: 1 day at ICU
prevalence of co-morbidities
Time frame: 1 day at ICU
prevalence of vital signs at icu admission
Time frame: at ICU admission
prevalence of complications during icu stay
Time frame: from ICU admission to cross sectional moment (29/3/2020)
evaluation of treatment
Time frame: from ICU admission to cross sectional moment (29/3/2020)
evaluation of the oxygen therapy
Time frame: from ICU admission to cross sectional moment (29/3/2020)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Deep Vein Thrombosis (DVT)/Thrombophlebitis, run by Jessa Hospital at 1 site in Belgium.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 19 May 2020. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the prevalence of a DVT in patients at the ICU. (time frame: 1 day at ICU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 May 2020; AzTrials last refreshed its copy on 31 Oct 2026.