RecruitingNot ApplicableNCT06386107

Thrombin Generation Parameters and Bleeding in Patients Treated With Anticoagulants for Cancer Associated Thrombosis

Association Between Thrombin Generation Parameters and the Risk of Bleeding in Patients Treated With Anticoagulants for Cancer Associated Thrombosis (CAT) (a Multicenter Study)

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Enrollment

212 participants

Start Date

Sep 2, 2025

Study Type

INTERVENTIONAL

Conditions

Cancer Thrombosis Pulmonary Embolism

Summary

Pulmonary embolism, the second leading cause of death in cancer patients, is effectively treated with anticoagulants. In patients with cancer-associated thrombosis (CAT), the use of anticoagulants is associated with 10 to 15% of bleeding in the first 6 months. Most of the guidelines propose to integrate the bleeding risk in the choice of therapies. Thrombin generation assay (TGA) reflects an overall hemostatic response and could be a useful biomarker. Proven on the thrombotic side in the CAT population, useful in the assessment of the bleeding risk of hemophiliac patients, the TGA is emerging as a tool. The investigators to measure TGA in cancer patients included prospectively, having recently developed a CAT and to evaluate the association between the measurement and the risk of hemorrhagic complication under anticoagulant during the first 6 month of treatment.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This French study is examining blood clotting measurements in people with cancer who develop blood clots (deep vein thrombosis or pulmonary embolism) and are being treated with anticoagulants (blood thinners), to see if those measurements can predict bleeding risk. **You may be eligible if...** - You have active cancer - You have been diagnosed with a blood clot in a deep vein or your lungs (DVT or PE), confirmed by imaging - You have no reason that you cannot take blood-thinning medication **You may NOT be eligible if...** - You are already enrolled in a blinded or experimental treatment clinical trial - You are already taking blood thinners for heart or rhythm conditions - You have blood cancer (like leukemia or lymphoma) - You cannot safely take anticoagulants - You have already been switched to a DOAC (direct oral anticoagulant) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALThrombin Generation Assay (TGA)

Hemostasis is a complex process in which genetic or environmental conditions can cause shifts either towards pro-thrombotic states resulting in thrombosis, or towards pro-hemorrhagic states resulting in uncontrolled bleeding. Tests to assess a more global hemostatic profile, such as the TGA, have appeared as a more reliable alternative to assess the real hemostatic capacity of an individual. TGA is a global dynamic assay simultaneously and continuously measuring thrombin generation. It monitors the cleavage of a fluorigenic substrate that is simultaneously compared to the known thrombin activity in a non-clotting plasma sample.