Thrombin generation testing to predict bleeding in cancer patients on anticoagulants for thrombosis

Association Between Thrombin Generation Parameters and the Risk of Bleeding in Patients Treated With Anticoagulants for Cancer Associated Thrombosis (CAT) (a Multicenter Study)

This project will test whether a thrombin generation blood test can help predict which cancer patients treated with anticoagulants for a recent deep vein thrombosis or pulmonary embolism are more likely to have bleeding within six months.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 212 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre Hospitalier Universitaire de Saint Etienne (Academic / other)
• Locations: 4 sites (Clermont-Ferrand and 3 other locations)
• Trial ID: NCT06386107 on ClinicalTrials.gov

What this trial studies

This multicenter prospective project will enroll patients with active cancer who have a new proximal deep vein thrombosis or at least segmental pulmonary embolism and who are starting curative-dose anticoagulation. Investigators will measure thrombin generation assay (TGA) parameters at inclusion and follow patients for six months to record hemorrhagic complications. The goal is to determine whether baseline TGA adds predictive value to existing clinical models, which currently perform poorly in this population. Collaborators include university hospitals in Saint-Étienne, Clermont-Ferrand, Grenoble and Lyon and industry partners providing assay support.

Who should consider this trial

Good fit: Ideal candidates are adults with active solid-tumor cancer who have a new proximal lower-limb DVT and/or segmental-or-larger pulmonary embolism and who can start curative-dose anticoagulation.

Not a fit: Patients with hematologic malignancies, those already on therapeutic anticoagulation for another indication, those with a contraindication to anticoagulation, or those already switched to a DOAC before inclusion are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the test could help identify patients at higher bleeding risk so clinicians can personalize anticoagulant choice or monitoring to reduce harm.

How similar studies have performed: Thrombin generation assays have shown usefulness for thrombotic risk in cancer and for bleeding assessment in hemophilia, but their ability to predict anticoagulant-related bleeding in cancer patients is largely unproven and remains exploratory.

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.

Where this trial is running

Clermont-Ferrand and 3 other locations

• Chu Clermont-Ferrand — Clermont-Ferrand, France (Not_yet_recruiting)
• CHU de Grenoble — Grenoble, France (Not_yet_recruiting)
• Hcl — Lyon, France (Not_yet_recruiting)
• Chu St-Etienne — Saint-Etienne, France (Recruiting)

Study contacts

• Principal investigator: Géraldine POENOU, MD PHD — Centre Hospitalier Universitaire de Saint Etienne
• Study coordinator: Géraldine POENOU, MD PHD

Conditions Cancer; Pulmonary Embolism; Thrombosis; Anticoagulant associated bleeding