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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Saint Etienne

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Thrombin Generation Assay (TGA)

Treatment groups

212 Participants
are divided into 1 treatment group

Sponsors and collaborators

Centre Hospitalier Universitaire de Saint Etienne

Lead sponsor

Diagnostica Stago

Collaborator

LEO Pharma

Collaborator

Ligue contre le cancer, France

Collaborator