- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02569606
Transfusion and Coagulation Management in Trauma Patients After the Introduction of a Coagulation Algorithm
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Lucerne, 스위스, 6000
- Lucerne Kantonssital
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Zurich, 스위스, 8091
- University Hospital Zurich
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 보병대
- 시간 관점: 회고전
코호트 및 개입
그룹/코호트 |
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Timeframe 2005 - 2007
Data of timeframe 2005 up to 2007 will be included
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Timeframe 2012 - 2014
Data of timeframe 2012 up to 2014 will be included
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
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.
기간: up to 48 hours
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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.
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up to 48 hours
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Comparison of the rate of massive transfusion in reality with the predicted rate (by TASH) score.
기간: up to 48 hours
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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.
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up to 48 hours
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Comparison of the predicted mortality (TRISS/RISC2) with the actual rate
기간: up to 30 days
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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.
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up to 30 days
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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- ZH 2015 - 0309
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