Transfusion Requirements in Cardiac Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Transfusion Requirements in Cardiac Surgery (TRICS II): A Randomized Controlled Trial

Conditions
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Cardiac Surgery

Intervention / Treatment
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* Other: Liberal transfusion triggers
* Other: Restrictive transfusion triggers


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older European System for Cardiac Operative Risk Evaluation (EuroSCORE) of 6 or more Consent Exclusion Criteria: Pregnancy Refusal of blood products Participating in autologous blood donation program Based on the preoperative hemoglobin, the predicted hematocrit on cardiopulmonary bypass is greater than 33% (hemoglobin concentration of 110 g/L) or less than 18% (hemoglobin concentration of 60 g/L)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Restrictive transfusion triggers<br>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. | Other: Restrictive transfusion triggers<br>* 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.<br>|
| Active Comparator: Liberal transfusion triggers<br>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. | Other: Liberal transfusion triggers<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transfusion, cardiac surgery