Investigating Clonal Hematopoiesis and Neutrophil Extracellular Traps in Venous Thrombosis
Role of Clonal Hematopoiesis and NETs Formation in Unusual Venous Thrombosis (CLODETTE)
This study is trying to see if certain blood changes are linked to repeated blood clots in younger people who don’t have the usual risk factors.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 6 Years to 50 Years |
| Sex | All |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Locations | 7 sites (Bordeaux and 6 other locations) |
| Trial ID | NCT05711173 on ClinicalTrials.gov |
What this trial studies
This study examines the role of clonal hematopoiesis of indeterminate potential (CHIP) and neutrophil extracellular trap (NET) formation in patients under 50 years old who experience repeated venous thrombosis or thrombosis in unusual sites. It aims to determine the prevalence of CHIP and NETosis in this population, particularly in cases where traditional risk factors for thrombosis are absent. By analyzing blood samples, the study seeks to uncover potential underlying mechanisms that contribute to these thrombotic events, which could improve management strategies for affected patients.
Who should consider this trial
Good fit: Ideal candidates are individuals under 50 years old with repeated venous thrombosis or thrombosis in unusual sites and no identifiable risk factors.
Not a fit: Patients with known major or minor transient risk factors for venous thrombosis or those with active cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and management of venous thrombosis in younger patients, potentially reducing recurrence rates.
How similar studies have performed: While some studies have explored the role of CHIP and NETs in other thrombotic conditions, this specific investigation into venous thrombosis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bordeaux and 6 other locations
- CHU de Bordeaux, Service de Neurologie — Bordeaux, France (Not_yet_recruiting)
- CHU de Bordeaux, Service Gastro-Entérologie — Bordeaux, France (Not_yet_recruiting)
- CHU de Bordeaux, Service Hématologie Biologique — Bordeaux, France (Recruiting)
- CHU de Bordeaux, Service Médecine Vasculaire — Bordeaux, France (Recruiting)
- CHU de Bordeaux, Unité ambulatoire de Médecine Vasculaire — Bordeaux, France (Recruiting)
- CHU de Lille, Service Hémostase Clinique — Lille, France (Not_yet_recruiting)
- APHM - Hôpital de la Timone, Service Hématologie — Marseille, France (Not_yet_recruiting)
Study contacts
- Principal investigator: Alexandre GUY — University Hospital, Bordeaux
- Study coordinator: Alexandre GUY
- Email: alexandre.guy@chu-bordeaux.fr
- Phone: 0557656478
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.