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

Cancer Clinical Trial

— CATforCAT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06386107
• Other study ID #: 23PH188
• Secondary ID: 2023-A02175-40
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: August 2026

Study information

• Verified date: April 2024
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: Géraldine POENOU, MD PHD
• Phone: (0)477828919
• Email: geraldine.poenou[@]chu-st-etienne.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 212
• Est. completion date: August 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 (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 blinded therapy will be excluded.
• 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.

Related Conditions & MeSH terms

• Cancer
• Embolism
• Hemorrhage
• Pulmonary Embolism
• Thrombosis

Intervention

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.

Locations

Country	Name	City	State
France	Chu Clermont-Ferrand	Clermont-Ferrand
France	CHU de Grenoble	Grenoble
France	HCL	Lyon
France	Chu St-Etienne	Saint-Étienne

Sponsors (4)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Diagnostica Stago, LEO Pharma, Ligue contre le cancer, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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