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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Chu St-Etienne
  Saint-Etienne, France Recruiting
• Chu Clermont-Ferrand
  Clermont-Ferrand, France Not yet recruiting
• CHU de Grenoble
  Grenoble, France Not yet recruiting
• Hcl
  Lyon, France Not yet recruiting

Study contacts

• Principal investigator: Géraldine POENOU, MD PHD — Centre Hospitalier Universitaire de Saint Etienne
• Study coordinator: Géraldine POENOU, MD PHD
• Email: geraldine.poenou@chu-st-etienne.fr
• Phone: (0)477828919

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.