Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06386107

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

Led by Centre Hospitalier Universitaire de Saint Etienne · Updated on 2026-02-12

212

Participants Needed

4

Research Sites

147 weeks

Total Duration

On this page

Sponsors

C

Centre Hospitalier Universitaire de Saint Etienne

Lead Sponsor

D

Diagnostica Stago

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Chu Clermont-Ferrand

Clermont-Ferrand, France, 63003

Not Yet Recruiting

2

CHU de Grenoble

Grenoble, France, 38043

Not Yet Recruiting

3

HCL

Lyon, France

Not Yet Recruiting

4

Chu St-Etienne

Saint-Etienne, France, 42055

Actively Recruiting

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Research Team

G

Géraldine POENOU, MD PHD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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