Transfusion Triggers in Cardiac Surgery (TTRICS)

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Surgery
• Intervention / Treatment: Procedure: Transfusion with Red Blood Cells; Biological: 1 unit of donated red blood cells; Biological: 1 unit 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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5B 1W8
      • St. Michael's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Biological: 1 unit of donated red blood cells; Units of donated red blood cells
Active Comparator: 2; Restrictive transfusion strategy	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	Day of surgery through to hospital discharge.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Unity Health Toronto
• Collaborators: Canadian Blood Services
• Investigators: Principal Investigator: David Mazer, MD, St. Michael's Hospital, University of Toronto

Publications and helpful links

General Publications

• Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5.
• Hebert PC, Wells G, Blajchman MA, Marshall J, Martin C, Pagliarello G, Tweeddale M, Schweitzer I, Yetisir E. A multicenter, randomized, controlled clinical trial of transfusion requirements in critical care. Transfusion Requirements in Critical Care Investigators, Canadian Critical Care Trials Group. N Engl J Med. 1999 Feb 11;340(6):409-17. doi: 10.1056/NEJM199902113400601. Erratum In: N Engl J Med 1999 Apr 1;340(13):1056.
• Dupuis JY, Wang F, Nathan H, Lam M, Grimes S, Bourke M. The cardiac anesthesia risk evaluation score: a clinically useful predictor of mortality and morbidity after cardiac surgery. Anesthesiology. 2001 Feb;94(2):194-204. doi: 10.1097/00000542-200102000-00006.
• Shehata N, Burns LA, Nathan H, Hebert P, Hare GM, Fergusson D, Mazer CD. A randomized controlled pilot study of adherence to transfusion strategies in cardiac surgery. Transfusion. 2012 Jan;52(1):91-9. doi: 10.1111/j.1537-2995.2011.03236.x. Epub 2011 Jul 25.

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: May 3, 2007
• First Submitted That Met QC Criteria: May 4, 2007
• First Posted (Estimate): May 7, 2007

Study Record Updates

• Last Update Posted (Estimate): July 31, 2015
• Last Update Submitted That Met QC Criteria: July 30, 2015
• Last Verified: November 1, 2008

More Information

Terms related to this study

• Keywords: Cardiac Surgery; Transfusion Medicine; Cardiac Anesthesia Risk Evaluation (CARE) Score of 3 or 4; (Dupuis J-Y et al, Anesthesiology 2001;94: 194-204)
• Other Study ID Numbers: REB 06-185