Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Recruiting Not applicable

Clonal Hematopoiesis and NETs Formation in Venous Thrombosis (CLODETTE)

NCT05711173 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2023-03-03
Last updated
2025-03-21

Condition(s) studied

Venous ThrombosesThromboembolic DiseaseNeutrophil Extracellular Trap FormationClonal Hematopoiesis of Indeterminate Potential

Investigational drug(s) / intervention(s)

Additional blood sampling →

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

Study 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

Sex
ALL
Min age
6 Years
Max age
50 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Presence of clonal hematopoiesis — At baseline
    The existence of clonal hematopoiesis will be defined as the demonstration of at least one mutation in the blood cells of an apparently healthy subject (without obvious hematological pathology). DNA will be extracted from circulating leukocytes to search for mutations in a panel of 59 genes

Trial sites (7)

FacilityCityRegionStatus
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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05711173 on ClinicalTrials.gov ↗ ← All trials in France