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

Sponsor: Centre Hospitalier Universitaire de Saint Etienne • ClinicalTrials.gov ID: NCT06386107

Registry updated: 2026-08-24
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Description

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.

Interventions

  • Thrombin Generation Assay (TGA) (Biological)
    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.

Eligibility criteria

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.

Conditions

Cancer Pulmonary Embolism Thrombosis

Locations

  • Chu Clermont-Ferrand — Clermont-Ferrand, France
  • CHU de Grenoble — Grenoble, France
  • HCL — Lyon, France
  • Chu St-Etienne — Saint-Etienne, France
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record