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Transfusion Triggers in Cardiac Surgery (TTRICS)

This study has been completed.
Canadian Blood Services
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto Identifier:
First received: May 3, 2007
Last updated: July 30, 2015
Last verified: November 2008
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.

Condition Intervention
Cardiac Surgery
Procedure: Transfusion with Red Blood Cells
Biological: 1 unit of donated red blood cells

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Transfusion Triggers in Cardiac Surgery

Resource links provided by NLM:

Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • 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. [ Time Frame: Day of surgery through to hospital discharge. ]

Secondary Outcome Measures:
  • 1) enrollment rates 2) proportion of missing data 3) indicators for hypoxemia 4) mean number of red cell units used 5) clinical outcomes [ Time Frame: Day of surgery through to hospital discharge ]

Enrollment: 50
Study Start Date: December 2006
Study Completion Date: May 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Liberal transfusion strategy
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
Active Comparator: 2
Restrictive transfusion strategy
Biological: 1 unit of donated red blood cells
Units of donated red blood cells

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00470444

Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Canadian Blood Services
Principal Investigator: David Mazer, MD St. Michael's Hospital, University of Toronto