Clinical trial NCT06386107: Thrombin Generation Parameters and Bleeding in Patients Treated With Anticoagulants for Cancer Associated Thrombosis
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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cancer
Pulmonary Embolism
Thrombosis
Keywords: Cancer
Thrombosis
Anticoagulant associated bleeding
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Diagnostica Stago
name: LEO Pharma
name: Ligue contre le cancer, France
First posted: 2024-04-26
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The measurement of the area under the curve ( endogenious thrombin potential) nMxmin
timeFrame: during the first 6 months of treatment
measure: the measurement of the lag time unit = seconds
timeFrame: during the first 6 months of treatment
measure: the measurement of the peak height unit = nm
timeFrame: during the first 6 months of treatment
measure: the measurement of the time to peak unit = seconds
timeFrame: during the first 6 months of treatment
Secondary outcomes:
measure: Effect of adding TGT results on the performance of bleeding risk prediction scores
timeFrame: Month 1; Month 6
measure: Occurrence of clinically relevant bleeding between m1 and m6, based on the change in TGT
timeFrame: Month 1; Month 6
measure: Occurrence of an event of interest under treatment
timeFrame: Month : 1 to 6
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Chu Clermont-Ferrand
city: Grenoble
country: France
facility: CHU de Grenoble
city: Lyon
country: France
facility: HCL
city: Saint-Étienne
country: France
facility: Chu St-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Géraldine POENOU, MD PHD
role: PRINCIPAL_INVESTIGATOR
References: