Actively Recruiting

Phase Not Applicable
Age: 6Years - 50Years
All Genders
NCT05711173

Clonal Hematopoiesis and NETs Formation in Venous Thrombosis (CLODETTE)

Led by University Hospital, Bordeaux · Updated on 2025-03-21

150

Participants Needed

7

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official 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 under 50 years old (male or female)
  • History of splanchnic venous thrombosis or cerebral venous thrombosis
  • History of venous thrombosis of the upper limb
  • History of unprovoked pulmonary embolism (1st episode if male, 2nd episode if female)
  • History of one deep vein thrombosis episode plus one arterial thrombosis episode
Not Eligible

You will not qualify if you...

  • Surgery within 3 months before the qualifying thrombotic episode
  • Lower limb fracture with immobilization longer than 3 days within 3 months before the qualifying thrombotic episode
  • Use of estro-progestational contraception
  • Pregnancy
  • Immobilization for acute medical reasons within 3 months before the qualifying thrombotic episode
  • Air or car travel longer than 6 hours
  • Presence of active cancer (solid or hematologic)
  • Chronic inflammatory digestive or joint diseases
  • Ongoing treatment with heparin (LMWH or UFH)
  • Abnormalities in thrombophilia tests including Protein C deficiency, Protein S deficiency, Anti-thrombin deficiency, Factor II or Factor V mutations
  • Presence of anti-phospholipid syndrome
  • Presence of myeloproliferative neoplasia
  • Presence of paroxysmal nocturnal hemoglobinuria

AI-Screening

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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

CONTACT

C

Chloé JAMES

CONTACT

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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