Actively Recruiting

Phase Not Applicable
Age: 6Years - 50Years
All Genders
ID05711173

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

Age: 6Years - 50Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

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

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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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