Transfusion Triggers in Cardiac Surgery (TTRICS)

Unity Health Toronto

Status: Completed

Conditions: Cardiac Surgery

Treatments: Procedure: Transfusion with Red Blood Cells; Biological: 1 unit of donated red blood cells

Study type: Interventional

Funder types: Other

Identifiers

NCT00470444

REB 06-185

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

1

Active Comparator group

Description:

Liberal transfusion strategy

Treatment:

Procedure: Transfusion with Red Blood Cells

Biological: 1 unit of donated red blood cells

Biological: 1 unit of donated red blood cells

2

Active Comparator group

Description:

Restrictive transfusion strategy

Treatment:

Biological: 1 unit of donated red blood cells

Biological: 1 unit of donated red blood cells