Evolution of Thromboelastography During Tranexamic Acid Treatment
- Conditions
- Hematological Malignancies Treated With Intensive Chemotherapy
- Interventions
- Registration Number
- NCT03801122
- 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 intensive chemotherapy in patients with hematological malignancies.
- 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 are commonly given to raise any low platelet count and reduce the risk of clinical bleeding (prophylaxis) or stop active bleeding (therapy). The last studies have showed that many patients continue to experience bleeding, despite the use of platelet transfusions. Tranexamic acid is an antifibrinolytic agent. It reduces the breakdown of clots formed. This treatment is widely used in medicine (e.g. emergency, surgery, post-partum) and decreases blood loss and the use of red cell transfusions. The purpose of this study is to test different doses of tranexamic acid (full dose: 3g/day and half dose (1.5g/day) and to study its effect by thromboelastography, with the aim to determine the optimal posology for further clinical studies.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tranexamic acid 3g/day Tranexamic acid Administration of tranexamic acid 3g/day, with 3 injections/8 hours. Tranexamic acid 1.5g/day Tranexamic acid Administration of tranexamic acid 1.5g/day, with 3 injections/8 hours.
- Primary Outcome Measures
Name Time Method Level of amplitude observed in thromboelastography 30 days Amplitude levels observed in thromboelastography will be reported
- Secondary Outcome Measures
Name Time Method Time at the beginning of the clot 30 minutes Time at the beginning of the clot will be reported in minutes
Clot formation time 30 minutes Clot formation time will ne reported in minutes
Alpha angle 30 days Alpha angle will be measured in degrees
Percentage of lysis after 30min 30 minutes Percentage of lysis after 30min will be measured
Number of adverse events 3 months Number of adverse events will be reported
Proportion of patients experiencing bleeding of WHO (World Health Organisation ) grade 2 or above 30 days Proportion of patients experiencing bleeding of WHO (World Health Organisation ) grade 2 or above will be reported
Trial Locations
- Locations (1)
CHU de Saint-Etienne
🇫🇷Saint-Étienne, France