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NCT06386107Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 24 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
212 (estimated)
First submitted
22 Jan 2024
Start date
2 Sept 2025
Primary completion date
31 Jul 2027
Lead sponsor
Centre Hospitalier Universitaire de Saint Etienne
NCT number
NCT06386107

What you commit to

  • Study type: Interventional
  • Planned participants: 212
  • From 2 Sept 2025 to the primary completion date, 31 Jul 2027
  • 4 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • Patients already on anticoagulant at a curative dose for valvular or rhythmic embolic disease or a history of venous thromboembolic disease
  • Hematological malignancies

Other

  • Patients with a contraindication to anticoagulant treatment on inclusion
  • Patient whose relay by DOAC has already been carried out.

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU Clermont-Ferrand
Coordinator of this site? Confirm its status
Clermont-FerrandFranceNot yet recruiting
CHU de Grenoble
Coordinator of this site? Confirm its status
GrenobleFranceNot yet recruiting
HCL
Coordinator of this site? Confirm its status
LyonFranceNot yet recruiting
Chu St-Etienne
Coordinator of this site? Confirm its status
Saint-EtienneFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.