RecruitingNot ApplicableNCT05711173

Clonal Hematopoiesis and NETs Formation in Venous Thrombosis (CLODETTE)

Role of Clonal Hematopoiesis and NETs Formation in Unusual Venous Thrombosis (CLODETTE)


Sponsor

University Hospital, Bordeaux

Enrollment

150 participants

Start Date

Mar 3, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 6 YearsMax Age: 50 Years

Inclusion Criteria6

  • 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
  • episode of deep vein thrombosis + 1 episode of arterial thrombosis

Exclusion Criteria20

  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALAdditional blood sampling

The procedure will consist of an additional blood sample for ETDA tube collection (NGS analysis) and citrate tube collection (NETose analysis)


Locations(7)

CHU de Bordeaux, Service de Neurologie

Bordeaux, France

CHU de Bordeaux, Service Gastro-Entérologie

Bordeaux, France

CHU de Bordeaux, Service Hématologie Biologique

Bordeaux, France

CHU de Bordeaux, Service Médecine Vasculaire

Bordeaux, France

CHU de Bordeaux, Unité ambulatoire de Médecine Vasculaire

Bordeaux, France

CHU de Lille, Service Hémostase Clinique

Lille, France

APHM - Hôpital de la Timone, Service Hématologie

Marseille, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05711173


Related Trials