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?
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Alberta
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Calgary, Alberta, 캐나다, T2N 2T9
- Dr. Charles McAdams
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Edmonton, Alberta, 캐나다
- Blaine Achen
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British Columbia
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Vancouver, British Columbia, 캐나다, V5Z 1M9
- Dr. Terry Waters
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Vancouver, British Columbia, 캐나다
- Dr. Sukhpal Brar
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Manitoba
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Winnipeg, Manitoba, 캐나다, R2H 2A6
- Dr. H. Grocott
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Ontario
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Hamilton, Ontario, 캐나다, L8N 3Z5
- Dr. Summer Syed
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London, Ontario, 캐나다, N6A 5A5
- Dr. Christopher Harle
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Newmarket, Ontario, 캐나다, L3Y 2P9
- Dr. Daniel Kim
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Ottawa, Ontario, 캐나다, K1Y 4W7
- Dr. D. Tran
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Toronto, Ontario, 캐나다, M4N 3M5
- Dr. F. Moussa
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Quebec
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Fleurimont, Quebec, 캐나다, J1H 5N4
- Dr. E. Medicis
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Sainte -Foy, Quebec, 캐나다, G1V 4G5
- Dr. J. Bussieres
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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다른: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Point Of Care (POC) Transfusion Algorithm Cardiac Study
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Transfusion
기간: 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
기간: 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
기간: 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
기간: 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
기간: 7 days
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Arrhythmias, sternal infection, myocardial infarction, stroke, thromboembolic events, and death
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7 days
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공동 작업자 및 조사자
간행물 및 유용한 링크
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 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 14-7495-A
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