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

Not Applicable

Not yet recruiting

• Conditions: Pulmonary Embolism; Cancer; Thrombosis
• Interventions: Biological: Thrombin Generation Assay (TGA)

• Registration Number: NCT06386107
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief 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.

Detailed 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. Existing models for predicting anticoagulant associated bleeding risk applied to the CAT patients are not very predictive (AUC\<0.60). 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 wish 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.

Study Timeline

• Study First Submitted: 2024-01-22
• Study First Submitted QC: 2024-04-23
• Study First Posted: 2024-04-26
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-03-30
• Study Start: 2025-06
• Primary Completion: 2026-02
• Study Completion: 2027-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 212

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 (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 blinded therapy will be excluded.
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with cancer associated thrombosis under curative anticoagulant treatment	Thrombin Generation Assay (TGA)	Patients with cancer associated thrombosis under curative anticoagulant treatment.

Primary Outcome Measures

Name	Time	Method
The measurement of the area under the curve ( endogenious thrombin potential) nMxmin	during the first 6 months of treatment	The measurment of the endogenious thrombin potential, during the first 6 months of treatment
the measurement of the lag time unit = seconds	during the first 6 months of treatment	the measurement of the lag time, during the first 6 months of treatment
the measurement of the peak height unit = nm	during the first 6 months of treatment	the measurement of the peak height during the first 6 months of treatment.
the measurement of the time to peak unit = seconds	during the first 6 months of treatment	the mesearurement of the time to peak, during the first 6 months of treatment.

Secondary Outcome Measures

Name	Time	Method
Occurrence of an event of interest under treatment	Month : 1 to 6	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.
Occurrence of clinically relevant bleeding between m1 and m6, based on the change in TGT	Month 1; Month 6	Occurrence of clinically relevant bleeding between m1 and m6, based on the change in TGT (between inclusion and m1)
Effect of adding TGT results on the performance of bleeding risk prediction scores	Month 1; Month 6	Effect of adding TGT results on the performance (via AUC) of bleeding risk prediction scores.

Trial Locations

Locations (4)

Chu Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

CHU de Grenoble; 🇫🇷 Grenoble, France

HCL; 🇫🇷 Lyon, France

Chu St-Etienne; 🇫🇷 Saint-Étienne, France