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临床试验/NCT04866953
NCT04866953已完成不适用

At What Point is Blood Transfusion Futile in Trauma?: A Retrospective Study of Ultra Massive Transfusion Protocol in Adult Trauma Patients Undergoing Surgery Within 24 Hours and Effects on Mortality and Clinical Outcomes

University of Southern California1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2021年8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
3,000
试验地点
1
主要终点
24-hour mortality

研究概览

简要总结

The purpose of this study is to determine the effects of ultraMTP (>/=30 units pRBC within 24 hours) in trauma patients on mortality and secondary outcomes. The aim is to determine if there is a set number of pRBC units transfused in adult trauma patients undergoing surgery within 24 hours, after which mortality is inevitable and further transfusions are futile.

详细描述

Rationale: To determine if there is a set number of pRBC units transfused in adult trauma patients undergoing surgery within 24 hours, after which mortality is inevitable and further transfusions are futile.

Intervention: Blood transfusions administered to adult trauma patients undergoing surgery within 24 hours of admission.

Objectives/Purpose: The main objective of this study is to examine the outcomes associated with large volume transfusions at U.S. level I trauma centers in adult trauma patients undergoing surgery within 24 hours of admission. The investigators aim to determine the mortality rate associated with ultraMTP (defined as >/= 30 units pRBC within 24 hours), and the effects of ultraMTP on secondary outcomes. The investigators would also like to compare outcomes among patients who receive various amounts of pRBC units within 24 hours. The information learned through this study will aid in determining whether there is a threshold transfusion amount, after which outcomes significantly worsen, and resuscitation efforts are futile and should cease, in order to save hospital resources, time, and costs.

Study Population/Sample Characteristics: Adult trauma patients requiring surgery within 24 hours of admission who receive blood products.

Study Methodology: This is a multicenter, retrospective observational study.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • >/= 18 years old
  • trauma patient
  • undergoing surgery within first 24 hours of admission
  • received blood products within 24 hours of admission

排除标准

  • <18-years-old
  • no surgery within the first 24 hours
  • did not receive blood products within the first 24 hours

结局指标

主要结局

24-hour mortality

时间窗: 24 hours

24-hour mortality (yes/no)

次要结局

  • In-hospital mortality(through study completion, an average of 1 year)
  • ICU length of stay(through study completion, an average of 1 year)
  • discharge disposition(through study completion, an average of 1 year)
  • hospital length of stay(through study completion, an average of 1 year)
  • mechanical ventilator days(through study completion, an average of 1 year)
  • complications(through study completion, an average of 1 year)
  • Multiple organ system failure(through study completion, an average of 1 year)
  • 30-day mortality(30 days)

研究者

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

Catherine Kuza, MD

Assistant Professor of Anesthesiology

University of Southern California

研究点 (1)

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