Cancer, Pulmonary Embolism, Thrombosis
Conditions
Keywords
Cancer, Thrombosis, Anticoagulant associated bleeding
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.
Interventions
BIOLOGICALThrombin 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.
Sponsors
Centre Hospitalier Universitaire de Saint Etienne
Diagnostica Stago
LEO Pharma
Ligue contre le cancer, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The measurement of the area under the curve ( endogenious thrombin potential) nMxmin | during the first 6 months of treatment | The measurment of the endogenious thrombin potential, during the first 6 months of treatment |
| the measurement of the lag time unit = seconds | during the first 6 months of treatment | the measurement of the lag time, during the first 6 months of treatment |
| the measurement of the peak height unit = nm | during the first 6 months of treatment | the measurement of the peak height during the first 6 months of treatment. |
| the measurement of the time to peak unit = seconds | during the first 6 months of treatment | the mesearurement of the time to peak, during the first 6 months of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of adding TGT results on the performance of bleeding risk prediction scores | Month 1; Month 6 | Effect of adding TGT results on the performance (via AUC) of bleeding risk prediction scores. |
| Occurrence of clinically relevant bleeding between m1 and m6, based on the change in TGT | Month 1; Month 6 | Occurrence of clinically relevant bleeding between m1 and m6, based on the change in TGT (between inclusion and m1) |
| Occurrence of an event of interest under treatment | 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. |
Countries
France
Contacts
CONTACTGéraldine POENOU, MD PHD
PRINCIPAL_INVESTIGATORGéraldine POENOU, MD PHD
Centre Hospitalier Universitaire de Saint Etienne
Outcome results
None listed