Study of thromboelastography during tranexamic acid treatment in preventing bleeding in patients with haematological malignancies presenting severe thrombocytopenia (TTRAP-bleeding) - TTRAP-bleeding

Institut de Cancérologie Lucien Neuwirth0 个研究点目标入组 18 人开始时间: 2018年12月19日最近更新: 2019年4月30日

适应症

试验速览

暂无简介。

•- 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

发起方

Institut de Cancérologie Lucien Neuwirth