Venous ThrombosesCLODETTENCT05711173
Clonal Hematopoiesis and NETs Formation in Venous Thrombosis (CLODETTE)
A study testing Additional blood sampling in people with Venous Thromboses and Thromboembolic Disease, run by University Hospital, Bordeaux at 7 sites in France.
Trial summary
Thrombo-embolic venous diseases are represented by deep venous thrombosis and/or pulmonary embolism. In some patients with repeated thrombosis or occurrence of thrombosis in unusual sites, the etiological workup remains negative, which represents a problem for the management of the anticoagulant treatments. Read more about this study
- Who is it for?
- Ages 6 to 50 years
- Conditions the study is for
- Venous Thromboses, Thromboembolic Disease, Neutrophil Extracellular Trap Formation
- What is being tested?
- Additional blood sampling
- How many people
- 150 participants
- Where
- 7 sitesFrance
- Study dates
- 3 Mar 2023to Mar 2027
- Phase
- Interventional
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 6 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients (male or female) less than 50 y.o with :
- Splanchnic venous territory thrombosis or
- Cerebral venous thrombosis or
- Venous thrombosis of the upper limb or
- Pulmonary embolism (1st episode if male, 2nd episode if female) unprovoked or
- 1 episode of deep vein thrombosis + 1 episode of arterial thrombosis
Who cannot join
- Presence of a major or minor transient venous thrombosis risk factor:
- Surgery within the last 3 months preceding the qualifying thrombotic episode
- Lower limb fracture with immobilization > 3 days in the last 3 months preceding the qualifying thrombotic episode
- Presence of estro-progestational contraception
- Pregnancy
- Immobilization for acute medical reasons within the last 3 months preceding the qualifying thrombotic episode
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- Air or car travel > 6 hours
- Presence of a major or minor persistent risk factor for venous thrombosis:
- Presence of active cancer (solid cancer or hematologic malignancy)
- Chronic inflammatory digestive or joint diseases
- Ongoing treatment with heparin (low molecular weight heparin (LMWH) or unfractionated heparin (UFH))
- Presence of an abnormality on the thrombophilia test among the following abnormalities
- Protein C deficiency
- Protein S deficiency
- Anti-thrombin deficiency
- Heterozygous or homozygous factor II mutation
- Heterozygous or homozygous factor V mutation
- Presence of anti-phospholipid syndrome
- Presence of myeloproliferative neoplasia
- Presence of paroxysmal nocturnal hemoglobinuria
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
France7 sites, 7 recruiting
- Not yet recruiting
CHU de Bordeaux, Service de Neurologie
Bordeaux
Igor SIBON, igor.sibon@chu-bordeaux.fr
- Not yet recruiting
CHU de Bordeaux, Service Gastro-Entérologie
Bordeaux
Paul HERMABESSIERE, paul.hermabessiere@chu-bordeaux.fr
- Recruiting
CHU de Bordeaux, Service Hématologie Biologique
Bordeaux
Alexandre GUY, alexandre.guy@chu-bordeaux.fr
- Recruiting
CHU de Bordeaux, Service Médecine Vasculaire
Bordeaux
Joël CONSTANS, joel.constans@chu-bordeaux.fr
- Recruiting
CHU de Bordeaux, Unité ambulatoire de Médecine Vasculaire
Bordeaux
Sophie SKOPINSKI, sophie.skopinski@chu-bordeaux.fr
- Not yet recruiting
CHU de Lille, Service Hémostase Clinique
Lille
Nathalie TRILLOT, nathalie.trillot@chu-lille.fr
- Not yet recruiting
APHM - Hôpital de la Timone, Service Hématologie
Marseille
Pierre SUCHON, PIERRE.SUCHON@ap-hm.fr
About this study
Official title: Role of Clonal Hematopoiesis and NETs Formation in Unusual Venous Thrombosis (CLODETTE)
Thrombo-embolic venous diseases are represented by deep venous thrombosis and/or pulmonary embolism. In some patients with repeated thrombosis or occurrence of thrombosis in unusual sites, the etiological workup remains negative, which represents a problem for the management of the anticoagulant treatments. Recently, two factors have been identified as important in the physiopathology of hemostasis and coagulation: the presence of clonal hematopoiesis of indetermined potential (CHIP) and the formation of neutrophil extracellular traps (NETs). In this study, these two factors will be studied in patients with repeated venous thrombosis or thrombosis occurring in unusual site.
Read the detailed description
It has recently been shown that some patients clonal have mutations at a low level in hematopoietic cells (this phenomenon is named clonal hematopoiesis of indetermined potential (CHIP)) and that the presence of a clonal hematopoiesis is associated with an increased cardiovascular risk. However, few data exist about the implication of CHIP in venous thrombosis. Neutrophils extracellular traps are involved in the activation of hemostasis and coagulation. Murine models have highlighted the crucial role of NETs in the physiopathology of venous thrombosis. In patients, studies have demonstrated that NETs markers were present in arteries lesions as coronary plaques. However, few studies have analyzed the NETosis in the setting of venous thrombosis.
The study hypothesis is that patients with venous thrombosis may have an increased prevalence of CHIP and/or an increased NETosis formation, which may represent a predisposition for the occurrence of venous thrombosis. We also speculate that patients with CHIP may have an increased NETosis, due to the presence of activating clonal mutations in neutrophils.
Patients included will be : younger than 50-years-old with repeated thrombosis or thrombosis of unusual sites (cerebral venous thrombosis, splanchnic thrombosis) with a negative etiological workup and notably the absence of constitutional or acquired venous thrombosis risk factors. In this population, we will analyze the prevalence of CHIP and the NETosis via the study of 4 different NETosis plasmatic markers.
- Conditions
- Venous Thromboses, Thromboembolic Disease, Neutrophil Extracellular Trap Formation, Clonal Hematopoiesis of Indeterminate Potential
- Being tested
- Additional blood sampling
- Keywords
- Thrombosis, Venous thrombosis, Clonal hematopoiesis of indetermined potential
- Medical subject headings
- Venous Thrombosis, Thromboembolism, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional blood samplingBiological
The procedure will consist of an additional blood sample for ETDA tube collection (NGS analysis) and citrate tube collection (NETose analysis)
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of clonal hematopoiesis
The existence of clonal hematopoiesis will be defined as the demonstration of at least one mutation in the blood cells of an apparently healthy subject (without obvious hematological pathology). DNA will be extracted from circulating leukocytes to search for mutations in a panel of 59 genes
Measured: At baseline
Secondary outcomes (7)
Presence of one or more increased NETosis markers and/or a decreased NETosis-inhibiting marker (DNAse level) compared to a control population.
Analysis of the following markers: MPO-DNA complex, Histone 3-DNA complex, citrullinated histone 3, DNAse
Measured: At baseline
Correlation (correlation coefficient values) between the presence of a CHIP and the formation of NETs
Correlation analysis will be performed between each NETosis marker and CHIP evaluation (presence or absence, number of mutations, variant allele frequency for each mutation)
Measured: During final analysis
Allele frequency
Variant allele frequency of each detected mutation will be determined using NGS analysis
Measured: At baseline
Number of clonal mutations
The number of clonal mutations for each patient will be determined using NGS analysis
Measured: At baseline
C-reactive protein (CRP) level as a marker of inflammation
C-reactive protein concentration will be determined for each patient, as a marker of inflammation
Measured: At baseline
Site(s) of thrombosis
Site(s) of thrombosis will be determined during examination of the patient
Measured: At baseline
Number of thrombosis
The number of thrombosis will be determined during examination of the patient
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start3 Mar 2023
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThrombosesStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandre GUY, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05711173
- Sponsor's protocol ID
- CHUBX 2022/32
- Acronym
- CLODETTE
- Status last verified
- Mar 2025
- First submitted
- 24 Jan 2023
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No