POC - Transfusion Algorithm Cardiac Study (TACS)
Blood Conservation in Cardiac Surgery Using a Novel Transfusion Algorithm Based on Point-of-care Testing-A Stepped-wedge Cluster Randomized Controlled Trial
This multi-centre study will provide sound, generalizable data on the effectiveness of a POC-based algorithm to determine to what extent this guideline can reduce blood product transfusions. Investigators will study outcomes in 7000 patients undergoing heart surgery at 10 participating hospitals. The proposed trial addresses several important research and clinical issues and has the potential to markedly improve the transfusion management and surgical care in general of cardiac surgery patients.
The intervention will be a novel POC-based algorithm that has been shown in a pilot study by us to be associated with a substantial reduction in blood product transfusions. The algorithm will employ viscoelastic and aggregometric POC-tests and an objective measure of blood loss. The primary outcome will be avoidance of red blood cell transfusion during hospitalization. The study has a 90% power to detect a 12% increase in avoidance rate. Secondary outcomes will include avoidance of red blood cell use and other blood products (plasma, platelets, and cryoprecipitate), units of blood products transfused, and adverse clinical outcomes related to transfusion (acute kidney injury, infections, and death). Data will also be collected for future health-economics analyses.
Largely due to the limitations of existing evidence, however, such algorithms are rarely used in clinical practice. The proposed trial will provide sound, generalizable data on the effectiveness of a POC-based algorithm to guide their future use. An integrated blood management algorithm that employs POC coagulation tests will reduce blood product transfusions in cardiac surgery, thereby improving clinical outcomes.
Does an integrated blood transfusion algorithm that employs POC coagulation tests applied across a network of hospitals reduce blood transfusions and associated adverse outcomes in cardiac surgery?
調査の概要
詳細な説明
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
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Alberta
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Calgary、Alberta、カナダ、T2N 2T9
- Dr. Charles McAdams
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Edmonton、Alberta、カナダ
- Blaine Achen
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British Columbia
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Vancouver、British Columbia、カナダ、V5Z 1M9
- Dr. Terry Waters
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Vancouver、British Columbia、カナダ
- Dr. Sukhpal Brar
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Manitoba
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Winnipeg、Manitoba、カナダ、R2H 2A6
- Dr. H. Grocott
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Ontario
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Hamilton、Ontario、カナダ、L8N 3Z5
- Dr. Summer Syed
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London、Ontario、カナダ、N6A 5A5
- Dr. Christopher Harle
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Newmarket、Ontario、カナダ、L3Y 2P9
- Dr. Daniel Kim
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Ottawa、Ontario、カナダ、K1Y 4W7
- Dr. D. Tran
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Toronto、Ontario、カナダ、M4N 3M5
- Dr. F. Moussa
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Quebec
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Fleurimont、Quebec、カナダ、J1H 5N4
- Dr. E. Medicis
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Sainte -Foy、Quebec、カナダ、G1V 4G5
- Dr. J. Bussieres
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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
説明
Hospital Inclusion:
- Participating hospitals must not currently be using a POC-based blood conservation algorithm; must have an in-hospital RBC transfusion rate of > 35% and platelet or plasma transfusion rates of > 20%; must conduct > 600 cardiac surgeries employing CPB per year; and must have commitments from departments of Anesthesia, Cardiac Surgery, and Laboratory Medicine to support the study and to abide by the algorithm
- Blood transfusion algorithm instituted as standard-of-care at participating hospitals
- All adult (≥ 18 years) patients undergoing cardiac surgery with cardiopulmonary bypass (CPB) will be included in the analysis.
Exclusion Criteria: Hospitals not meeting inclusion.
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
- 主な目的：診断
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：Transfusion Algorithm
Hospitals will be randomized to the intervention arm of the study in a stratified manner.
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A transfusion algorithm based on point-of-care coagulation testing.
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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 |
|---|---|---|
|
Point Of Care (POC) Transfusion Algorithm Cardiac Study
時間枠：2.5 years
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The primary outcome measure will be the proportion of patients who receive any allogeneic red blood cell (RBC) transfusion from admission before surgery to end of follow-up.
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2.5 years
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Transfusion
時間枠：7 days
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Allogeneic blood products (platelets, plasma, cryoprecipitate) or coagulation factors (e.g., fibrinogen concentrate, factor VIIa), or undergo re-exploration; units of blood products transfused, nadir hemoglobin concentration (to identify changes in transfusion practice that may be unrelated to treatment of coagulopathy)
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7 days
|
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Blood loss
時間枠：24 hours
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Chest-tube drainage at 6 and 24 hours after surgery
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24 hours
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Ventilation and hospital stay
時間枠：24 hours to 7 days
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Duration of mechanical ventilation and length of stay in the ICU and hospital
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24 hours to 7 days
|
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Kidney injury
時間枠：48 hours
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Incidence of acute kidney injury, defined as a ≥ 2-fold in increase in creatinine or new renal replacement therapy within 48 hours after surgery
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48 hours
|
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Post operative complications
時間枠：7 days
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Arrhythmias, sternal infection, myocardial infarction, stroke, thromboembolic events, and death
|
7 days
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協力者と研究者
出版物と役立つリンク
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 (見積もり)
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
その他の研究ID番号
- 14-7495-A
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