Malignant hemopathy
Conditions
Interventions
Trade Name: EXACYL
Pharmaceutical Form: Solution for injection
Sponsors
Institut de Cancérologie Lucien Neuwirth
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: - evaluation of the anti-fibrinolytic activity by the other parameters - overall assessment of coagulation - assessment of clot fibrin - incidence of bleeding episodes - tolerance (incidence of side effects: thromboembolic event, nausea, vomiting, diarrhea, color vision disorder, skin allergy, convulsions, acute tubular necrosis, death). ;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
| Measure | Time frame |
|---|---|
| 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), - 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), - 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, - incidence of side effects (thromboembolic event, nausea, vomiting, diarrhea, color vision disorder, skin allergy, seizures, acute tubular necrosis, death) ;Timepoint(s) of evaluation of this end point: 120 days | — |
Countries
France
Contacts
Public ContactMathilde Gras
Institut de Cancérologie Lucien Neuwirth
Outcome results
None listed