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临床试验/NCT05583539
NCT05583539撤回不适用

A Pilot Study of Thromboelastography Guided Blood Product Transfusion for Patient With Cirrhosis and Upper Gastrointestinal Bleeding

Vanderbilt University Medical Center0 个研究点开始时间: 2025年1月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
主要终点
Volume of fresh frozen plasma transfused

研究概览

简要总结

The goal of this clinical trial is to compare resuscitation strategies in patients with cirrhosis and gastrointestinal bleeding. The main question it aims to answer is whether thromboelastography guided resuscitation decreased the amount of fresh frozen plasma patients receive. Patients will receive blood products guided by thromboelastography in the intervention group. Researchers will compare the patients who undergo thromboelastography guided resuscitation to those who receive usual care to see which strategy leads to the use of less blood products, specifically less fresh frozen plasma.

研究设计

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

入排标准

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

入选标准

  • •Patient aged 18 years or older
  • •Octreotide order placed for the indication of upper gastrointestinal bleeding in cirrhosis

排除标准

  • 未提供

研究组 & 干预措施

Usual Care

No Intervention

Patients will receive usual care at the discretion of their providers.

Thromboelastography guided resuscitation

Experimental

Patients will undergo thromboelastography testing that will be used by primary providers to guide blood product resuscitation.

干预措施: Thromboelastography (Diagnostic Test)

结局指标

主要结局

Volume of fresh frozen plasma transfused

时间窗: From time of randomization to hospital discharge, up to 3 months

The total volume of fresh frozen plasma transfused

次要结局

  • Patients requiring fresh frozen plasma transfusion(From time of randomization to hospital discharge, up to 3 months)
  • Control of bleeding at 5 days(Measured at 5 days from the time of octreotide order placement)
  • Rebleeding at 42 days(The earlier of 42 days from the time of octreotide placement or hospital discharge)
  • Volume of platelets and cryoprecipitate transfused(From time of randomization to hospital discharge, up to 3 months)
  • Mortality rate during index hospitalization(From time of randomization to hospital discharge, up to 3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Todd Rice

Professor of Medicine

Vanderbilt University Medical Center

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