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NCT Number: NCT06386107

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

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.

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Key information

Conditions

Cancer Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Neoplasms Pulmonary Embolism Respiratory Tract Diseases Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Clermont-Ferrand, Clermont-Ferrand, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Thrombin Generation Assay (TGA)

Biological

Hemostasis is a complex process in which genetic or environmental conditions can cause shifts either towards pro-thrombotic states resulting in thrombosis, or towards pro-hemorrhagic states resulting in uncontrolled bleeding. Tests to assess a more global hemostatic profile, such as the TGA, have appeared as a more reliable alternative to assess the real hemostatic capacity of an individual. TGA is a global dynamic assay simultaneously and continuously measuring thrombin generation. It monitors the cleavage of a fluorigenic substrate that is simultaneously compared to the known thrombin activity in a non-clotting plasma sample.

Primary outcomes

  1. The measurement of the area under the curve ( endogenious thrombin potential) nMxmin

    Time frame: during the first 6 months of treatment

    The measurment of the endogenious thrombin potential, during the first 6 months of treatment

  2. the measurement of the lag time unit = seconds

    Time frame: during the first 6 months of treatment

    the measurement of the lag time, during the first 6 months of treatment

  3. the measurement of the peak height unit = nm

    Time frame: during the first 6 months of treatment

    the measurement of the peak height during the first 6 months of treatment.

  4. the measurement of the time to peak unit = seconds

    Time frame: during the first 6 months of treatment

    the mesearurement of the time to peak, during the first 6 months of treatment.

Secondary outcomes

  1. Effect of adding TGT results on the performance of bleeding risk prediction scores

    Time frame: Month 1; Month 6

    Effect of adding TGT results on the performance (via AUC) of bleeding risk prediction scores.

  2. Occurrence of clinically relevant bleeding between m1 and m6, based on the change in TGT

    Time frame: Month 1; Month 6

    Occurrence of clinically relevant bleeding between m1 and m6, based on the change in TGT (between inclusion and m1)

  3. Occurrence of an event of interest under treatment

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Géraldine POENOU, MD PHD

CONTACT

[email protected]

(0)477828919 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • Diagnostica Stago
  • LEO Pharma
  • Ligue contre le cancer, France

Registry information

Official study title

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

Acronym: CATforCAT

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Apr 26, 2024
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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