Thrombin Generation Parameters and Bleeding in Patients Treated With Anticoagulants for Cancer Associated Thrombosis
Recruiting · NCT06386107 · Interventional (participants receive a specific treatment) · Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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 (at least segmental) (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
Exclusion criteria
- Patients participating in a therapeutic clinical trial with a blinded therapy or an open-label therapeutic trial who are included in the experimental treatment group.
- Patients already on anticoagulant at a curative dose for valvular or rhythmic embolic disease or a history of venous thromboembolic disease
- Hematological malignancies
- Patients with a contraindication to anticoagulant treatment on inclusion
- Patient whose relay by DOAC has already been carried out.
Where it is running
4 locations listed.
- Chu Clermont-Ferrand - Clermont-Ferrand, France
- CHU de Grenoble - Grenoble, France
- HCL - Lyon, France
- Chu St-Etienne - Saint-Etienne, France