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临床试验/NCT02569606
NCT02569606已完成不适用

Transfusion and Coagulation Management in Trauma Patients After the Introduction of a Coagulation Algorithm

Donat R. Spahn2 个研究点 分布在 1 个国家目标入组 1,800 人开始时间: 2015年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,800
试验地点
2
主要终点
Comparison the consumption of red blood cells, fresh frozen plasma and platelets in the treatment period by the Anaesthesist and after 24/48 hours before (2005-2007) and after (2012-2014) launching the coagulation algorithm.

研究概览

简要总结

Comparison of the consumption of blood and coagulation products (packed red blood cells, fresh frozen plasma, platelet concentrates, fibrinogen, coagulation factor concentrates, coagulation factor XIII, activated factor VII, van Willebrand factor and antifibrinolytics) before and after the introduction of a designated trauma related transfusion and coagulation algorithm.The periods 2005-2007 (before) and 2012-2014 (after) the introduction are reviewed. Two level-1 trauma centers in Switzerland (Hospital Lucerne, University Hospital Zurich) are included in the study. Predicted probability of a massive transfusion by the trauma associated acute hemorrhage score (TASH)is correlated with the actual rate.

详细描述

Trauma is one of the leading causes of death worldwide. After death due to direct craniofacial injury, exsanguination is the next major cause for trauma mortality.

After initial pre-hospital treatment the patient is admitted to the hospital. If multiple injuries are present the patient is transferred to a specialized trauma center.

Besides surgical treatment, the patient needs stabilization of the vital functions by the Anesthesiologist. Due to loss of blood volume, dilution of the circulatory blood volume and pathological activation of coagulation/fibrinolysis, trauma induced coagulopathy (TIC) is initiated. This needs to be treated and avoided whenever possible.

Transfusion of allogeneic blood and coagulation product itself leads to an increased morbidity and mortality. Infectious and immunologic reactions account for that phenomenon.

This led to a paradigm change in the therapy of TIC. In 2009 a new coagulation factor based coagulation algorithm was introduced in the Hospital Lucerne and the University Hospital in Zurich / Switzerland. With the help of point of care coagulation measurement, tailored coagulation factor based coagulation management and avoidance of allogeneic blood products was initiated.

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

入选标准

  • male and female trauma patients
  • admitted to the University hospital of Zurich or the Hospital of Lucerne, Switzerland
  • injury severity score >= 16
  • time period 2005-2007 and 2012-2014

排除标准

  • incomplete data
  • denial of informed consent

结局指标

主要结局

Comparison the consumption of red blood cells, fresh frozen plasma and platelets in the treatment period by the Anaesthesist and after 24/48 hours before (2005-2007) and after (2012-2014) launching the coagulation algorithm.

时间窗: up to 48 hours

The coagulation algorithm was launched in 2010. To show the difference in transfusion and administration of coagulation products prior and after the changes of coagulation algorithm the probability of massive transfusion (TASH Score) will be compared with the actual rate. The TASH Score is the most precise predictive probability of a massive transfusion. Data of approximately 1800 participants will be compared.

Comparison of the rate of massive transfusion in reality with the predicted rate (by TASH) score.

时间窗: up to 48 hours

Massive transfusion (\>10 units of blood) can be predicted on the base of patient and trauma epidemiology. The investigator compares the actual rate in the institution with the rate predicted by the score.

次要结局

  • Comparison of the predicted mortality (TRISS/RISC2) with the actual rate(up to 30 days)

研究者

发起方
Donat R. Spahn
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Donat R. Spahn

Head of Institut of Anesthesiology University Hospital Zurich

University of Zurich

研究点 (2)

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