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.
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
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
Single group
Thrombin Generation Assay (TGA)
Biological/VaccineHemostasis 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.
The measurement of the area under the curve ( endogenious thrombin potential) nMxmin
The measurment of the endogenious thrombin potential, during the first 6 months of treatment
the measurement of the lag time unit = seconds
the measurement of the lag time, during the first 6 months of treatment
the measurement of the peak height unit = nm
the measurement of the peak height during the first 6 months of treatment.
the measurement of the time to peak unit = seconds
the mesearurement of the time to peak, during the first 6 months of treatment.
Effect of adding TGT results on the performance of bleeding risk prediction scores
Effect of adding TGT results on the performance (via AUC) of bleeding risk prediction scores.
Occurrence of clinically relevant bleeding between m1 and m6, based on the change in TGT
Occurrence of clinically relevant bleeding between m1 and m6, based on the change in TGT (between inclusion and m1)
Occurrence of an event of interest under treatment
Occurrence of an event of interest under treatment (recurrence of CAT, death, clinically relevant bleeding event) during the 6 months of follow-up, according to the TGT assessment at inclusion.
Click on the lead sponsor to view all of their trials.
Centre Hospitalier Universitaire de Saint Etienne
Lead sponsor
Diagnostica Stago
Collaborator
LEO Pharma
Collaborator
Ligue contre le cancer, France
Collaborator
