Transfusion Triggers in Cardiac Surgery (TTRICS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by St. Michael's Hospital, Toronto.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Canadian Blood Services
Information provided by:
St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT00470444
First received: May 3, 2007
Last updated: December 2, 2008
Last verified: November 2008
  Purpose

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
Endpoint Classification: Safety Study
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. ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]

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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00470444

Contacts
Contact: David Mazer, MD 416-864-5825 mazerd@smh.toronto.on.ca
Contact: Nadine Shehata, MD 416-864-5128 shehatan@smh.toronto.on.ca

Locations
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         
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Canadian Blood Services
Investigators
Principal Investigator: David Mazer, MD St. Michael's Hospital, University of Toronto
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: C. David Mazer MD, St Michael's Hospital
ClinicalTrials.gov Identifier: NCT00470444     History of Changes
Other Study ID Numbers: REB 06-185
Study First Received: May 3, 2007
Last Updated: December 2, 2008
Health Authority: Canada: Health Canada

Keywords provided by St. Michael's Hospital, Toronto:
Cardiac Surgery
Transfusion Medicine
Cardiac Anesthesia Risk Evaluation (CARE) Score of 3 or 4
(Dupuis J-Y et al, Anesthesiology 2001;94: 194-204)

ClinicalTrials.gov processed this record on July 24, 2014