Trial | NCT00470444  Report issue

Official Title

Transfusion Triggers in Cardiac Surgery

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    red blood cells ...

  • Study Participants

    50
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.
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 Started
Dec 31
2006
Primary Completion
Apr 30
2009
Study Completion
May 31
2009
Last Update
Jul 31
2015
Estimate

Procedure Transfusion with Red Blood Cells

Units of donated Red blood cells

Biological 1 unit of donated red blood cells

Units of red blood cells

Biological 1 unit of donated red blood cells

Units of donated red blood cells

1 Active Comparator

Liberal transfusion strategy

2 Active Comparator

Restrictive transfusion strategy

Criteria 

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
No Results Posted