Transfusion and Coagulation Management in Trauma Patients After the Introduction of a Coagulation Algorithm
研究概览
地位
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
注册 (实际的)
联系人和位置
学习地点
-
-
-
Lucerne、瑞士、6000
- Lucerne Kantonssital
-
Zurich、瑞士、8091
- University Hospital Zurich
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
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
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
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- ZH 2015 - 0309
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.
出血的临床试验
-
Wake Forest University Health Sciences主动,不招人