Transfusion and Coagulation Management in Trauma Patients After the Introduction of a Coagulation Algorithm
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
-
Lucerne、スイス、6000
- Lucerne Kantonssital
-
Zurich、スイス、8091
- University Hospital Zurich
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：コホート
- 時間の展望：回顧
コホートと介入
グループ/コホート |
|---|
|
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
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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.
時間枠：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.
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Comparison of the predicted mortality (TRISS/RISC2) with the actual rate
時間枠：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
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- ZH 2015 - 0309
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。