Study of thromboelastography during tranexamic acid treatment in preventing bleeding in patients with haematological malignancies presenting severe thrombocytopenia (TTRAP-bleeding)
- Conditions
- Malignant hemopathyTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2018-004756-38-FR
- Lead Sponsor
- Institut de Cancérologie Lucien Neuwirth
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 18
- Major patient affiliated or entitled to a social security scheme
- Patient with haematological malignancy requiring intensive chemotherapy.
- Hospitalization for aplasia with thrombocytopenia expected less than 10 G / L more than 5 days
- Consent to participate in the signed study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 9
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 9
- Pregnant woman, minor, protected major
- Patient who is refractory to platelet transfusions or who requires a specific platelet delivery protocol
- Patient on anticoagulant or platelet antiaggregant at baseline
- Patient with a history of arterial or venous thromboembolism
- Patient receiving a pro-coagulant agent (eg DDAVP, recombinant Factor VIIa, Prothrombin Complexes and / or antifibrinolytic agent within 48 hours prior to inclusion or known hypercoagulability state (induction of acute promyelocytic leukemia, disseminated intravascular coagulation, thrombotic purpura thrombocytopenic, history of veno-occlusive disease ...)
- Patient with Grade 2 or greater bleeding from WHO within 7 days of inclusion
- Patient with creatinine clearance <30 mL / min
- Allergy known to tranexamic acid
- History of convulsions
- Patient already participating in a trial involving platelet transfusions, anti-fibrinolytics, other procoagulant agents or platelet growth factors
- Patient having expressed his opposition to participate in the study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Secondary Objective: - evaluation of the anti-fibrinolytic activity by the other parameters<br> - overall assessment of coagulation<br> - assessment of clot fibrin<br> - incidence of bleeding episodes<br> - tolerance (incidence of side effects: thromboembolic event, nausea, vomiting, diarrhea, color vision disorder, skin allergy, convulsions, acute tubular necrosis, death).<br> ;Primary end point(s): Evolution of the thromboelastogram under the effect of tranexamic acid by the maximum amplitude of the curve EXTEM.;Main Objective: Describe the evolution of thromboelastogram with tranexamic acid IV (usual dose of 3g / day versus a low dose of 1.5g / day versus no treatment) used to prevent bleeding observed during intensive chemotherapy in hematology during the period of severe thrombocytopenia (<50G / L).;Timepoint(s) of evaluation of this end point: 6 days
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): - evolution of the thromboelastogram under tranexamic acid by the other parameters of the EXTEM curve (time at the beginning of the clot, clot formation time, alpha angle, percentage of lysis after 30 min),<br> - evolution of the clot fibrin by the FIBTEM curve (maximum amplitude, time at the beginning of the clot, clot formation time, alpha angle, percentage of lysis after 30 min),<br> - incidence of WHO grade 2 or greater bleeding episodes during the first 30 days, number of serious grade 3-4 bleeding episodes, delay to 1st episode of bleeding, number of platelet concentrate transfusions, and erythrocytes, transfusion intervals,<br> - incidence of side effects (thromboembolic event, nausea, vomiting, diarrhea, color vision disorder, skin allergy, seizures, acute tubular necrosis, death)<br> ;Timepoint(s) of evaluation of this end point: 120 days