Status:
COMPLETED
Evolution of Thromboelastography During Tranexamic Acid Treatment
Lead Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Collaborating Sponsors:
Institut de Cancérologie de la Loire
Conditions:
Hematological Malignancies Treated With Intensive Chemotherapy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Patients with hematological malignancies are at increased risk of bleeding, especially during intensive chemotherapy. The aim of this study is to compare by thromboelastography changes during the inte...
Detailed Description
Patients with hematological malignancies often develop low platelet counts either as a consequence of the disease or the treatment by chemotherapy or stem cell transplantation. Platelet transfusions a...
Eligibility Criteria
Inclusion
- Patient affiliated to a social security regimen or beneficiary of the same
- Signed written informed consent form
- Confirmed diagnosis of a hematological malignancy and undergoing intensive chemotherapy
- Expected to experience hypoproliferative thrombocytopenia resulting in a platelet count of ≤10 G/L for ≥ 5 days
Exclusion
- Pregnant women
- Patient under guardianship or deprived of his liberty or any condition that may affect the patient's ability to understand and sign the informed consent
- Refractoriness to platelet transfusion or requirement for a specific type of platelet transfusion (ABO-compatible, plasma-free)
- Ongoing anticoagulant therapy or antiplatelet therapy at the time of enrolment
- Treatment with any pro-coagulant agent within 48 hours of enrolment, or enrolment in other trials involving platelet transfusions, platelet growth factors, or presentation of a known hypercoagulable state
- Diagnosis of arterial or venous thromboembolic disease within the previous year
- Patient experiencing a bleeding event WHO grade ≥ 2 within 7 days before inclusion
- contra-indications to tranexamic acid (allergy, history of seizures, creatinine clearance \< 30 mL/min)
- Refusing participation
Key Trial Info
Start Date :
March 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 11 2022
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT03801122
Start Date
March 5 2019
End Date
July 11 2022
Last Update
May 6 2023
Active Locations (1)
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1
CHU de Saint-Etienne
Saint-Etienne, France, 42055