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

NCT06386107 | Recruiting

• 2 other identifiers: 23PH1882023-A02175-40
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Cancer; Pulmonary Embolism; Thrombosis

Keywords

Cancer; Thrombosis; Anticoagulant associated bleeding

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

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

  Month 1; Month 6

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

  Month 1; Month 6

• Occurrence of an event of interest under treatment

  Month : 1 to 6

Study Arms (1)

Patients with cancer associated thrombosis under curative anticoagulant treatment

EXPERIMENTAL

Patients with cancer associated thrombosis under curative anticoagulant treatment.

Biological: Thrombin Generation Assay (TGA)

Interventions

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.

Patients with cancer associated thrombosis under curative anticoagulant treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• Patient whose relay by DOAC has already been carried out.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• Diagnostica Stago: collaborator
• LEO Pharma: collaborator
• Ligue contre le cancer, France: collaborator

Study Sites (4)

Chu Clermont-Ferrand

Clermont-Ferrand, 63003, France

NOT YET RECRUITING

CHU de Grenoble

Grenoble, 38043, France

NOT YET RECRUITING

HCL

Lyon, France

NOT YET RECRUITING

Chu St-Etienne

Saint-Etienne, 42055, France

RECRUITING

MeSH Terms

Conditions

Neoplasms; Pulmonary Embolism; Thrombosis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Géraldine POENOU, MD PHD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Géraldine POENOU, MD PHD

CONTACT

(0)477828919; geraldine.poenou@chu-st-etienne.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective cohort of consecutive patients initiating full-dose anticoagulant therapy for an episode of CAT, followed up until the 6th month of treatment to assess the risk of clinically relevant adjunctive bleeding events and any other adverse event during anticoagulant therapy (recurrence of CAT, death). TGT measurement is fully automated and calibrated with quality control.

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: April 26, 2024
• Study Start: September 2, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)