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

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT ETIENNE · Apr 23, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how a specific blood test, called the thrombin generation assay (TGA), can help doctors understand the risk of bleeding in cancer patients who are being treated with blood-thinning medications (anticoagulants) for conditions like deep vein thrombosis (DVT) and pulmonary embolism (PE). These conditions are serious complications that can occur in cancer patients, and while anticoagulants are effective in treating them, there is a risk of bleeding, especially during the first six months of treatment.

To be eligible for this trial, participants need to have active cancer and show signs of acute DVT or PE, confirmed by specific medical tests. They should not have any reasons that would prevent them from safely using anticoagulants. Participants will undergo the TGA blood test and will be monitored for any bleeding problems during their treatment. This study aims to better understand how to balance the benefits of anticoagulants with the potential risks of bleeding in cancer patients. It's important to note that this trial is not yet recruiting participants, but it represents a step towards improving care for those affected by cancer-related blood clots.

Gender

ALL

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.