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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients with active cancer, as defined by current French recommendations (Mahé I et al Rev Mal Respir 2021)

• Presenting acute proximal deep vein thrombosis of the lower limb (DVT) and/or proximal pulmonary embolism (PE), confirmed by objective tests (Doppler ultrasound in the event of DVT; lung scintigraphy or CT scan in the event of PE)

• No contraindication for anticoagulant treatment at a curative dose at the time of inclusion

Locations
Other Locations
France
Chu Clermont-Ferrand
NOT_YET_RECRUITING
Clermont-ferrand
CHU de Grenoble
NOT_YET_RECRUITING
Grenoble
HCL
NOT_YET_RECRUITING
Lyon
Chu St-Etienne
RECRUITING
Saint-etienne
Contact Information
Primary
Géraldine POENOU, MD PHD
geraldine.poenou@chu-st-etienne.fr
(0)477828919
Time Frame
Start Date: 2025-09-02
Estimated Completion Date: 2028-07
Participants
Target number of participants: 212
Treatments
Experimental: Patients with cancer associated thrombosis under curative anticoagulant treatment
Patients with cancer associated thrombosis under curative anticoagulant treatment.
Related Therapeutic Areas
Sponsors
Collaborators: LEO Pharma, Diagnostica Stago, Ligue contre le cancer, France
Leads: Centre Hospitalier Universitaire de Saint Etienne

This content was sourced from clinicaltrials.gov