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| ID | Type | Description | Link |
|---|---|---|---|
| Application #232416 | Other Grant/Funding Number | CIHR |
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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| Health Canada | OTHER_GOV |
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This is a multi-centre randomized controlled pilot trial of two transfusion strategies in high risk patients having cardiac surgery. This study will be conducted in 7 Canadian centers and 1 American centre. Patients allocated to a "restrictive" transfusion strategy will receive a red cell transfusion if their hemoglobin is 75 g/L or less intraoperatively and postoperatively. Patients allocated to a "liberal" transfusion strategy will receive red cell transfusion if their hemoglobin concentration is 95 g/L or less intraoperatively and postoperatively in the intensive care unit, and less than 85 g/L on the ward.
The primary objectives of this study are to determine 1) enrollment rates (patients enrolled/patients eligible), 2) consent rates (consent obtained/patients approached); and 3) protocol adherence (incidence and reasons for non adherence, lack of consent, rates of contamination and utilization of co-interventions). The secondary objectives are to determine 1) the mortality rate and the rate of the composite outcome for morbidity of renal, cardiac, neurological and infectious adverse events; 2) the proportion of missing data as a measure of the feasibility of the case report form; and 3) the proportion of blood products utilized (red cells, platelets and plasma).
The results of the multicentre pilot study will be used to 1) maximize enrollment rates to ensure timely completion of recruitment of a definitive large randomized controlled trial, 2) maximize adherence rates, 3) determine event rates for sample size estimation for a definitive study, and to 4) optimize the case report form.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Restrictive transfusion triggers | Active Comparator | Patients allocated to a "restrictive" transfusion group will receive a red cell transfusion if their hemoglobin is 75 g/L or less intraoperatively and postoperatively. |
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| Liberal transfusion triggers | Active Comparator | Patients allocated to a "liberal" transfusion strategy will receive red cell transfusion if their hemoglobin concentration is 95 g/L or less intraoperatively and postoperatively in the intensive care unit, and less than 85 g/L on the ward. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liberal transfusion triggers | Other | Patients allocated to a "liberal" transfusion strategy will receive red cell transfusion if their hemoglobin concentration is 95 g/L or less intraoperatively and postoperatively in the intensive care unit, and less than 85 g/L on the ward. |
| Measure | Description | Time Frame |
|---|---|---|
| Enrollment rate | To determine enrollment rates (patients enrolled/patients eligible), consent rates (consent obtained/patients approached) | baseline |
| Protocol adherence | To determine protocol adherence (incidence and reasons for non adherence, lack of consent, rates of contamination and utilization of co-interventions). | 28 days or hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality and morbidity | To determine the mortality rate and a composite outcome for morbidity (renal, cardiac, neurological and infectious adverse events). | 28 days or hospital discharge |
| Missing data |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nadine Shehata, MD | Li Ka Shing Knowledge Institute, Mount Sinai Hospital | Principal Investigator |
| David Mazer, MD | Unity Health Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States | ||
| Foothills Medical Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41114449 | Derived | Carson JL, Stanworth SJ, Dennis JA, Fergusson DA, Pagano MB, Roubinian NH, Turgeon AF, Valentine S, Trivella M, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2025 Oct 20;10(10):CD002042. doi: 10.1002/14651858.CD002042.pub6. |
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| Restrictive transfusion triggers | Other | Patients allocated to a "restrictive" transfusion group will receive a red cell transfusion if their hemoglobin is 75 g/L or less intraoperatively and postoperatively. |
|
To determine the proportion of missing data as a measure of the feasibility of the case report form
| 28 days or hospital discharge |
| Blood product utilization | To determine the proportion of blood products utilized (red cells, platelets and plasma) | 28 days or hospital discharge |
| Calgary |
| Alberta |
| T2N 2T9 |
| Canada |
| Alberta Health Services | Edmonton | Alberta | T6G2B7 | Canada |
| St. Boniface General Hospital | Winnipeg | Manitoba | R2H 2A6 | Canada |
| Hamilton General Hospital | Hamilton | Ontario | L8L 2X2 | Canada |
| Ottawa Heart Institute | Ottawa | Ontario | K1Y 4W7 | Canada |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
| St Michael's Hospital | Toronto | Ontario | M5B1W8 | Canada |