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临床试验/NCT03730415
NCT03730415已完成不适用

The Effects of Viscoelastic Guided Transfusions During Severe Thermal Injury Burn Excision on Post Transfusion Infections

University of Texas Southwestern Medical Center2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Number of blood products transfused

研究概览

简要总结

This is a randomized controlled trial to compare viscoelastometric (VE) guided transfusion to standard practice transfusion in severe thermal injury burn excision on the utilization of blood products, effects on coagulation and inflammatory mediators, and how these strategies affect post resuscitation infections.

详细描述

This is an open labeled study as the viscoelastometric (VE) guided transfusion will be based on the visible VE results. Subjects will be randomized to receive either the standard practice transfusion or VE guided transfusion. Blood samples, standard demographic information, and routine laboratory data will be collected on all subjects in the Burn ICU (BICU) enrolled in the study. VE analysis will be performed on ALL subjects immediately prior to the burn excision, and approximately every 40 minutes while the patient is in the operating room (OR) as well as on arrival to the BICU and every 8 hours depending on their need for ongoing transfusion for a maximum of 24 hours. As our intervention, only the VE based transfusion group will have access to the VE analysis at time of transfusion. The VE results will be used at the discretion of the treating physician based on the VE guided transfusion algorithm. Outcomes include the number and timing of blood products transfused from the time of randomization to 24 hours post randomization and the presence of any 30 day post-transfusion infections.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
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

入选标准

  • Burn patients admitted to Parkland Hospital with total burn surface area (TBSA) greater than 20%

排除标准

  • Patients admitted to Parkland Hospital for reasons other than burns or for burns less than or equal to 20%

结局指标

主要结局

Number of blood products transfused

时间窗: 24 hours post randomization

Compare the number of blood products transfused in VE guided transfusion versus standard practice transfusion in burned patients (TBSA \>20%) undergoing burn wound excision will be analyzed.

次要结局

  • Coagulation factors(excision to 24 hours post excision)
  • Inflammatory Mediators - plasminogen activator inhibitor 1(excision to 24 hours post excision)

研究者

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

Michael Cripps

Assistant Professor

University of Texas Southwestern Medical Center

研究点 (2)

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