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临床试验/NCT02689232
NCT02689232已完成不适用

TEG (Thromboelastography) Based Versus Conventional Coagulation Parameters Based Correction of Coagulopathy in Non Variceal Bleed: An Open Label Randomized Controlled Trial.

Institute of Liver and Biliary Sciences, India4 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2016年2月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
96
试验地点
4
主要终点
Amount of FFP (Fresh Frozen Plasma) transfusion in both groups

研究概览

简要总结

All patients with non variceal bleed who are admitted under the Department of Hepatology at Institute of Liver and Biliary Sciences, who meet the inclusion criteria and who provide informed consent.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age more than 18
  • All patient with Non Variceal bleed (INR>1.8 and platelets<50000)
  • Hist logical or imaging proven liver cirrhosis.

排除标准

  • Variceal Bleed,
  • Pregnancy.,
  • Patients on anticoagulation
  • Patients who refused to participate in the study
  • Post EVL ulcer bleed

结局指标

主要结局

Amount of FFP (Fresh Frozen Plasma) transfusion in both groups

时间窗: 42 days

次要结局

  • Number of patients with bleed in both groups(5 days)
  • Incidence of TRALI (Transfusion associated lung injury) and TACO ( Transfusion associated circulatory overload) in both the groups.(42 days)
  • Early mortality ( <6 weeks) and late mortality (> 6 weeks) in both the groups.(42 days)
  • Amount of blood products (Platelet and cryo and Red Blood Cells)transfused in both the groups.(42 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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