Actively Recruiting
Role of Clonal Hematopoiesis and NETs Formation in Unusual Venous Thrombosis (CLODETTE)
Led by University Hospital, Bordeaux · Updated on 2025-03-21
150
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating venous thromboembolic diseases like deep venous thrombosis and pulmonary embolism, especially in patients with repeated or unusual site thrombosis where standard causes are not found. The study focuses on two factors recently linked to blood clotting: clonal hematopoiesis of indeterminate potential (CHIP), where blood cells have mutations, and the formation of neutrophil extracellular traps (NETs), which may contribute to clot formation. This research aims to better understand how these factors relate to venous thrombosis in patients under 50 years old with no identifiable risk factors. Participants will undergo additional blood sampling to check for CHIP using next-generation sequencing and to measure NETosis markers through plasma analysis. The study will compare these markers in patients with repeated venous thrombosis or thrombosis in unusual sites such as splanchnic or cerebral veins. The research will analyze the presence and relationship of CHIP and NETs to assess their role in thrombosis development. During the study, patients will have blood drawn at baseline for various tests including CHIP detection, NETosis marker levels, inflammation markers like C-reactive protein, and documentation of thrombosis sites and frequency. Researchers will use this data to evaluate the prevalence of CHIP and NETosis in the study group and their potential correlation. The study is planned to continue until March 2027, and all assessments are conducted at baseline to gather comprehensive information about the participants' condition and blood markers.
CONDITIONS
Brief Title
Clonal Hematopoiesis and NETs Formation in Venous Thrombosis (CLODETTE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients less than 50 years old
- History of splanchnic venous thrombosis or cerebral venous thrombosis or venous thrombosis of the upper limb
- Pulmonary embolism: first episode if male, second episode if female, unprovoked
- One episode of deep vein thrombosis plus one episode of arterial thrombosis
- Male or female patients
You will not qualify if you...
- Surgery within 3 months before the qualifying thrombotic event
- Lower limb fracture with immobilization over 3 days within 3 months before the qualifying thrombotic event
- Use of estrogen-progestogen contraception
- Pregnancy
- Immobilization for acute medical reasons within 3 months before the qualifying thrombotic event
- Air or car travel longer than 6 hours
- Active cancer (solid or hematologic)
- Chronic inflammatory digestive or joint diseases
- Ongoing treatment with low molecular weight or unfractionated heparin
- Abnormal thrombophilia test including protein C or S deficiency, anti-thrombin deficiency, factor II or V mutations, anti-phospholipid syndrome
- Presence of myeloproliferative neoplasia
- Presence of paroxysmal nocturnal hemoglobinuria
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At baseline
Participants undergo additional blood sampling to analyze clonal hematopoiesis and NETosis markers related to venous thrombosis.
1 visit (in-person)
Trial Site Locations
Total: 7 locations
1
CHU de Bordeaux, Service de Neurologie
Bordeaux, France
Not Yet Recruiting
2
CHU de Bordeaux, Service Gastro-Entérologie
Bordeaux, France
Not Yet Recruiting
3
CHU de Bordeaux, Service Hématologie Biologique
Bordeaux, France
Actively Recruiting
4
CHU de Bordeaux, Service Médecine Vasculaire
Bordeaux, France
Actively Recruiting
5
CHU de Bordeaux, Unité ambulatoire de Médecine Vasculaire
Bordeaux, France
Actively Recruiting
6
CHU de Lille, Service Hémostase Clinique
Lille, France
Not Yet Recruiting
7
APHM - Hôpital de la Timone, Service Hématologie
Marseille, France
Not Yet Recruiting
Research Team
A
Alexandre GUY
C
Chloé JAMES
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
0
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