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

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

Study Overview

• Status: Recruiting
• Conditions: Cancer; Thrombosis; Pulmonary Embolism
• Intervention / Treatment: Biological: Thrombin Generation Assay (TGA)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 212
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Géraldine POENOU, MD PHD; Phone Number: +33 (0)477828919; Email: geraldine.poenou@chu-st-etienne.fr

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • Not yet recruiting
    • Chu Clermont-Ferrand
    • Principal Investigator: Dorian TEISSANDIER, MD
    • Sub-Investigator: Fares MOUSTAFA, MD PHD
    • Sub-Investigator: Jeannot SCHMIDT, MD PHD
    • Sub-Investigator: Aurélien LEBRETON, MD PHD
    • Sub-Investigator: Nicolas DUBLANCHET, MD
    • Contact: Dorian TEISSANDIER, MD
  • Grenoble, France, 38043
    • Not yet recruiting
    • Chu de Grenoble
    • Principal Investigator: Gilles PERNOD, MD PhD
    • Contact: Gilles PERNOD, MD PHD; Phone Number: +33 04 76 76 57 17; Email: gpernod@chu-grenoble.fr
    • Sub-Investigator: Raphaël MARLU, MD PHD
  • Lyon, France
    • Not yet recruiting
    • HCL
    • Contact: Yesim DARGAUD, MD PHD
    • Principal Investigator: Judith Catella, MD
    • Sub-Investigator: Yesim DARGAUD, MD PHD
    • Sub-Investigator: Stéphane LO, MD
  • Saint-Etienne, France, 42055
    • Recruiting
    • CHU St-Etienne
    • Sub-Investigator: Laurent BERTOLETTI, MD PHD
    • Contact: Géraldine POENOU, MD PHD; Email: geraldine.poenou@chu-st-etienne.fr
    • Sub-Investigator: Xavier DELAVENNE, MD PHD
    • Sub-Investigator: Coline LEGENDRE, MD
    • Sub-Investigator: Pauline NOYEL, MD
    • Sub-Investigator: Brigitte TARDY, MD PHD
    • Principal Investigator: Géraldine POENOU, MD PHD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients with cancer associated thrombosis under curative anticoagulant treatment; Patients with cancer associated thrombosis under curative anticoagulant treatment.

Biological: Thrombin Generation Assay (TGA); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The measurement of the area under the curve ( endogenious thrombin potential) nMxmin	The measurment of the endogenious thrombin potential, during the first 6 months of treatment	during the first 6 months of treatment
the measurement of the lag time unit = seconds	the measurement of the lag time, during the first 6 months of treatment	during the first 6 months of treatment
the measurement of the peak height unit = nm	the measurement of the peak height during the first 6 months of treatment.	during the first 6 months of treatment
the measurement of the time to peak unit = seconds	the mesearurement of the time to peak, during the first 6 months of treatment.	during the first 6 months of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of adding TGT results on the performance of bleeding risk prediction scores	Effect of adding TGT results on the performance (via AUC) of bleeding risk prediction scores.	Month 1; Month 6
Occurrence of clinically relevant bleeding between m1 and m6, based on the change in TGT	Occurrence of clinically relevant bleeding between m1 and m6, based on the change in TGT (between inclusion and m1)	Month 1; Month 6
Occurrence of an event of interest under treatment	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.	Month : 1 to 6

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: LEO Pharma; Ligue contre le cancer, France; Diagnostica Stago
• Investigators: Principal Investigator: Géraldine POENOU, MD PHD, CHU Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: January 22, 2024
• First Submitted That Met QC Criteria: April 23, 2024
• First Posted (Actual): April 26, 2024

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Cancer; Thrombosis; Anticoagulant associated bleeding
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Neoplasms; Pulmonary Embolism; Thrombosis; Hemostatics; Coagulants; Thrombin
• Other Study ID Numbers: 23PH188; 2023-A02175-40 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No