跳至主要内容
临床试验/NCT03765866
NCT03765866已完成不适用

Viscoelastic Guided Goal Directed Resuscitation of Severely Injured Patients

University of Texas Southwestern Medical Center2 个研究点 分布在 1 个国家目标入组 31 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
31
试验地点
2
主要终点
Change in number of blood products utilized at 24 hours

研究概览

简要总结

This is a randomized controlled trial to compare viscoelastic (VE) guided resuscitation to fixed-ratio resuscitation in trauma patients with hemorrhagic shock on the utilization of blood products, effects on coagulation and inflammatory mediators, and how these strategies affect post resuscitation adverse events.

详细描述

This is an open labeled study as the VE guided resuscitation will be based on the visible VE results. Aim 1 will compare the number of blood products utilized in each resuscitation strategy. Aim 2 will analyze the coagulation and inflammatory mediators in each resuscitation strategy to determine if there is a difference in the mechanism of coagulopathy. Aim 3 will determine if the different resuscitation strategies have an effect on post resuscitation adverse events.

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
14 Years 至 100 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Trauma patient
  • MTP Activation
  • Only patients ≥ 14 years old
  • Alive at 31 mins after arrival in ED

排除标准

  • Transfer from OSH
  • Received CPR for more than 5 mins
  • Pregnant or Prisoner
  • Jehovah's witness

结局指标

主要结局

Change in number of blood products utilized at 24 hours

时间窗: 24 hours from time of randomization

Number of blood products utilized during that time frame will be recorded to determine if change in resuscitation strategies result in measurable differences

次要结局

  • Change in coagulation profile(0 hours and 30 days)
  • Change in inflammatory mediators(0 hours and 30 days)
  • Changes in Resuscitation strategy-related adverse events(30 days after admission)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验