Clonal Hematopoiesis and NETs Formation in Venous Thrombosis (CLODETTE)

Launched by UNIVERSITY HOSPITAL, BORDEAUX · Jan 24, 2023

Keywords

ClinConnect Summary

The CLODETTE trial is studying two important factors that may play a role in certain types of blood clots, specifically in patients who experience repeated venous thrombosis (blood clots in the veins) or clots in unusual locations. These factors are called clonal hematopoiesis of indeterminate potential (CHIP) and neutrophil extracellular traps (NETs). The trial aims to better understand how these factors might contribute to clot formation, especially when the usual causes of clots can't be identified.

To participate in this study, you must be under 50 years old and have had specific types of venous thrombosis, such as clots in the brain or abdominal area, or an unprovoked pulmonary embolism (a type of lung clot). However, if you have had recent surgeries, fractures, or certain medical conditions, you may not qualify. If you join the study, you can expect to undergo tests to see how CHIP and NETs might be affecting your health. This research could help doctors develop better treatments for people with unexplained blood clots in the future.

Gender

ALL

Eligibility criteria

• 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