Transfusion Triggers in Cardiac Surgery

Not Applicable

Completed

• Conditions: Cardiac Surgery
• Interventions: Procedure: Transfusion with Red Blood Cells; Biological: 1 unit of donated red blood cells

• Registration Number: NCT00470444
• Lead Sponsor: Unity Health Toronto

Brief Summary

A high proportion of patients having cardiac surgery receive red cell transfusions. Yet, the investigators do not know whether transfusions are beneficial and they may be associated with harm. It is thus important to determine when a transfusion is required. The investigators will conduct a small pilot study at St. Michael's Hospital to address this issue. Patients having cardiac surgery will be allocated to one of two transfusion strategies with endpoints being compliance with the transfusion strategy and clinical outcome. The results of this study will be used to design a large definitive multicentered trial of these two transfusion strategies.

Detailed Description

The optimal hemoglobin concentrations for transfusion in the perioperative setting in patients having cardiac surgery have not been established, and red cell transfusion rates for these patients are high. In a recent retrospective study of seven Canadian centres, which included 11,812 cardiac surgical patients, 44% of patients received one or more red cell units, and the range of patients transfused was 28% to 60%. As morbidity and mortality may be dependent on the severity of anemia and administration of transfusions, it is essential to determine at what hemoglobin concentration physicians should be transfusing these patients, particularly because the efficacy of transfusion has not been established. However, as any definitive trial will require thousands of patients, and as there is variability in transfusion practices, preliminary studies need to be completed to ensure the feasibility of adherence to proposed transfusion strategies. This pilot study is the first of two pilot trials designed to address the question of optimum hemoglobin concentrations for transfusion in patients having cardiac surgery prior to undertaking a definitive randomized controlled trial. The purpose of this study is to determine adherence to transfusion strategies.

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2007-05-03
• Study First Submitted QC: 2007-05-04
• Study First Posted: 2007-05-07
• Status Verified: 2008-11
• Primary Completion: 2009-04
• Study Completion: 2009-05
• Last Update Submitted: 2015-07-30
• Last Update Posted: 2015-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Care Score of 3/4 or age >/= 80
• Signed informed consent

Exclusion Criteria

• Patients who refuse participation
• Unable to or refuse blood products
• Involved in an autologous pre-donation program

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Transfusion with Red Blood Cells	Liberal transfusion strategy
2	1 unit of donated red blood cells	Restrictive transfusion strategy
1	1 unit of donated red blood cells	Liberal transfusion strategy

Primary Outcome Measures

Name	Time	Method
Overall adherence to the transfusion strategies defined as adherence to the transfusion strategies in 90% of patients in more than 90% of their days in hospital.	Day of surgery through to hospital discharge.

Secondary Outcome Measures

Name	Time	Method
1) enrollment rates 2) proportion of missing data 3) indicators for hypoxemia 4) mean number of red cell units used 5) clinical outcomes	Day of surgery through to hospital discharge

Trial Locations

Locations (1)

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada