Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
St. Michael's Hospital, Toronto Canadian Blood Services |
---|---|
Information provided by: | St. Michael's Hospital, Toronto |
ClinicalTrials.gov Identifier: | NCT00470444 |
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: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study |
Official Title: | Transfusion Triggers in Cardiac Surgery |
Estimated Enrollment: | 50 |
Study Start Date: | December 2006 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
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
|
2: Active Comparator
Restrictive transfusion strategy
|
Biological: 1 unit of donated red blood cells
Units of donated red blood cells
|
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 |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: David Mazer, MD | 416-864-5825 | mazerd@smh.toronto.on.ca |
Contact: Nadine Shehata, MD | 416-864-5128 | shehatan@smh.toronto.on.ca |
Canada, Ontario | |
St. Michael's Hospital | Recruiting |
Toronto, Ontario, Canada, M5B 1W8 | |
Contact: David Mazer, MD 416-864-5825 mazerd@smh.toronto.on.ca | |
Contact: Douglas G. Michaud, HBSc 416-864-6060 ext 2920 michaudd@smh.toronto.on.ca | |
Principal Investigator: David Mazer, MD | |
Sub-Investigator: Nadine Shehata, MD | |
Sub-Investigator: Paul Hebert, MD | |
Sub-Investigator: Dean Fergusson, PhD | |
Sub-Investigator: Howard Nathan, MD |
Principal Investigator: | David Mazer, MD | St. Michael's Hospital, University of Toronto |
Responsible Party: | St Michael's Hospital ( C. David Mazer MD ) |
Study ID Numbers: | REB 06-185 |
Study First Received: | May 3, 2007 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00470444 |
Health Authority: | Canada: Health Canada |
Cardiac Surgery Transfusion Medicine Cardiac Anesthesia Risk Evaluation (CARE) Score of 3 or 4 (Dupuis J-Y et al, Anesthesiology 2001;94: 194-204) |