Transfusion Requirements in Cardiac Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-11-30

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.

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Detailed Description

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Conditions

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Cardiac Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Restrictive transfusion triggers

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.

Group Type ACTIVE_COMPARATOR

Restrictive transfusion triggers

Intervention Type 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.

Liberal transfusion triggers

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.

Group Type ACTIVE_COMPARATOR

Liberal transfusion triggers

Intervention Type 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.

Interventions

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Liberal transfusion triggers

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.

Intervention Type OTHER

Restrictive transfusion triggers

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.

Intervention Type OTHER

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No