NCT05711173 Clonal Hematopoiesis and NETs Formation in Venous Thrombosis (CLODETTE)
| NCT ID | NCT05711173 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Bordeaux |
| Condition | Venous Thromboses |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2023-03-03 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2023-03-03 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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
Contact & Investigator
Alexandre GUY
PRINCIPAL INVESTIGATOR
University Hospital, Bordeaux
Frequently Asked Questions
Who can join the NCT05711173 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 50 Years, studying Venous Thromboses. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05711173 currently recruiting?
Yes, NCT05711173 is actively recruiting participants. Contact the research team at alexandre.guy@chu-bordeaux.fr for enrollment information.
Where is the NCT05711173 trial being conducted?
This trial is being conducted at Bordeaux, France, Bordeaux, France, Bordeaux, France, Bordeaux, France and 3 additional locations.
Who is sponsoring the NCT05711173 clinical trial?
NCT05711173 is sponsored by University Hospital, Bordeaux. The principal investigator is Alexandre GUY at University Hospital, Bordeaux. The trial plans to enroll 150 participants.