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

2018年5月11日 更新者:Donat R. Spahn
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.

研究概览

地位

完全的

条件

详细说明

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.

The investigators now want to analyze the impact of the coagulation algorithm by comparing the periods before and after the introduction of the algorithm.

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 will be recorded and compared. The periods 2005-2007 (before) and 2012-2014 (after) the introduction are reviewed. Predicted probability of a massive transfusion by the TASH score (trauma associated acute hemorrhage) is correlated with the actual rate.

研究类型

观察性的

注册 (实际的)

1800

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Lucerne、瑞士、6000
        • Lucerne Kantonssital
      • Zurich、瑞士、8091
        • University Hospital Zurich

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

16年 及以上 (孩子、成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

概率样本

研究人群

All trauma patients with an injury severity score (ISS) >15 treated in University Hospital Zurich or Lucerne hospital during 2005 to 2007 and 2012 to 2014

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • incomplete data
  • denial of informed consent

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:队列
  • 时间观点:追溯

队列和干预

团体/队列
Timeframe 2005 - 2007
Data of timeframe 2005 up to 2007 will be included
Timeframe 2012 - 2014
Data of timeframe 2012 up to 2014 will be included

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
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.
大体时间: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.
up to 48 hours
Comparison of the rate of massive transfusion in reality with the predicted rate (by TASH) score.
大体时间: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.
up to 48 hours

次要结果测量

结果测量
措施说明
大体时间
Comparison of the predicted mortality (TRISS/RISC2) with the actual rate
大体时间:up to 30 days
TRISS is a common Score and is a comparative value for trauma mortality outcome. The investigators want to show the benefit of launched coagulation algorithm in mortality after severe trauma.
up to 30 days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2015年9月1日

初级完成 (实际的)

2017年9月1日

研究完成 (实际的)

2017年12月1日

研究注册日期

首次提交

2015年9月30日

首先提交符合 QC 标准的

2015年10月2日

首次发布 (估计)

2015年10月7日

研究记录更新

最后更新发布 (实际的)

2018年5月14日

上次提交的符合 QC 标准的更新

2018年5月11日

最后验证

2018年5月1日

更多信息

与本研究相关的术语

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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