POC - Transfusion Algorithm Cardiac Study
- Conditions
- Heart Diseases
- Interventions
- Other: POC-based transfusion algorithm
- Registration Number
- NCT02200419
- Lead Sponsor
- University Health Network, Toronto
- Brief Summary
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?
- Detailed Description
Despite major advances in cardiac surgery, coagulopathy continues to carry a heavy burden in cases that require the use of cardiopulmonary bypass (CPB), occurring frequently and resulting in excessive blood loss, blood product transfusions, and adverse clinical outcomes. Current management of coagulopathy is hampered by the inability of conventional laboratory tests to delineate its etiology in a timely manner, thereby precluding timely and targeted transfusion therapy. With the advent of point-of-care (POC) coagulation tests that can rapidly identify the etiology of coagulopathy, it may now be possible to reduce the burden of coagulopathy and thereby reduce transfusions and adverse outcomes. Several single-centre studies (including one by the investigator group) have found that the use of POC-based algorithms in cardiac surgery can markedly reduce blood product transfusions and by that means reduce morbidities and mortality.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7402
Not provided
Hospitals not meeting inclusion.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Transfusion Algorithm POC-based transfusion algorithm Hospitals will be randomized to the intervention arm of the study in a stratified manner.
- Primary Outcome Measures
Name Time Method Point Of Care (POC) Transfusion Algorithm Cardiac Study 2.5 years 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.
- Secondary Outcome Measures
Name Time Method Kidney injury 48 hours Incidence of acute kidney injury, defined as a ≥ 2-fold in increase in creatinine or new renal replacement therapy within 48 hours after surgery
Transfusion 7 days 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)
Blood loss 24 hours Chest-tube drainage at 6 and 24 hours after surgery
Ventilation and hospital stay 24 hours to 7 days Duration of mechanical ventilation and length of stay in the ICU and hospital
Post operative complications 7 days Arrhythmias, sternal infection, myocardial infarction, stroke, thromboembolic events, and death
Trial Locations
- Locations (12)
Dr. Summer Syed
🇨🇦Hamilton, Ontario, Canada
Dr. Charles McAdams
🇨🇦Calgary, Alberta, Canada
Blaine Achen
🇨🇦Edmonton, Alberta, Canada
Dr. Terry Waters
🇨🇦Vancouver, British Columbia, Canada
Dr. Sukhpal Brar
🇨🇦Vancouver, British Columbia, Canada
Dr. H. Grocott
🇨🇦Winnipeg, Manitoba, Canada
Dr. D. Tran
🇨🇦Ottawa, Ontario, Canada
Dr. Daniel Kim
🇨🇦Newmarket, Ontario, Canada
Dr. Christopher Harle
🇨🇦London, Ontario, Canada
Dr. F. Moussa
🇨🇦Toronto, Ontario, Canada
Dr. E. Medicis
🇨🇦Fleurimont, Quebec, Canada
Dr. J. Bussieres
🇨🇦Sainte -Foy, Quebec, Canada