Transfusion Requirements in Cardiac Surgery

NCT01484639 | Completed DMC

• 2 other identifiers: TRICSIIApplication #232416
• Study Type: interventional
• Target: 208
• Locations: 2 countries
• Sites: 8

Brief Summary

This is a multi-centre randomized controlled pilot trial of two transfusion strategies in high risk patients having cardiac surgery. This study will be conducted in 7 Canadian centers and 1 American centre. Patients allocated to a "restrictive" transfusion strategy will receive a red cell transfusion if their hemoglobin is 75 g/L or less intraoperatively and postoperatively. Patients allocated to a "liberal" transfusion strategy will receive red cell transfusion if their hemoglobin concentration is 95 g/L or less intraoperatively and postoperatively in the intensive care unit, and less than 85 g/L on the ward. The primary objectives of this study are to determine 1) enrollment rates (patients enrolled/patients eligible), 2) consent rates (consent obtained/patients approached); and 3) protocol adherence (incidence and reasons for non adherence, lack of consent, rates of contamination and utilization of co-interventions). The secondary objectives are to determine 1) the mortality rate and the rate of the composite outcome for morbidity of renal, cardiac, neurological and infectious adverse events; 2) the proportion of missing data as a measure of the feasibility of the case report form; and 3) the proportion of blood products utilized (red cells, platelets and plasma). The results of the multicentre pilot study will be used to 1) maximize enrollment rates to ensure timely completion of recruitment of a definitive large randomized controlled trial, 2) maximize adherence rates, 3) determine event rates for sample size estimation for a definitive study, and to 4) optimize the case report form.

Conditions

Cardiac Surgery

Keywords

transfusion; cardiac surgery

Outcome Measures

Primary Outcomes (2)

• Enrollment rate

  To determine enrollment rates (patients enrolled/patients eligible), consent rates (consent obtained/patients approached)

  baseline

• Protocol adherence

  To determine protocol adherence (incidence and reasons for non adherence, lack of consent, rates of contamination and utilization of co-interventions).

  28 days or hospital discharge

Secondary Outcomes (3)

• Mortality and morbidity

  28 days or hospital discharge

• Missing data

  28 days or hospital discharge

• Blood product utilization

  28 days or hospital discharge

Study Arms (2)

Restrictive transfusion triggers

ACTIVE COMPARATOR

Patients allocated to a "restrictive" transfusion group will receive a red cell transfusion if their hemoglobin is 75 g/L or less intraoperatively and postoperatively.

Other: Restrictive transfusion triggers

Liberal transfusion triggers

ACTIVE COMPARATOR

Patients allocated to a "liberal" transfusion strategy will receive red cell transfusion if their hemoglobin concentration is 95 g/L or less intraoperatively and postoperatively in the intensive care unit, and less than 85 g/L on the ward.

Other: Liberal transfusion triggers

Interventions

Liberal transfusion triggers OTHER

Patients allocated to a "liberal" transfusion strategy will receive red cell transfusion if their hemoglobin concentration is 95 g/L or less intraoperatively and postoperatively in the intensive care unit, and less than 85 g/L on the ward.

Liberal transfusion triggers

Restrictive transfusion triggers OTHER

Patients allocated to a "restrictive" transfusion group will receive a red cell transfusion if their hemoglobin is 75 g/L or less intraoperatively and postoperatively.

Restrictive transfusion triggers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• European System for Cardiac Operative Risk Evaluation (EuroSCORE) of 6 or more
• Consent

You may not qualify if:

• Pregnancy
• Refusal of blood products
• Participating in autologous blood donation program
• Based on the preoperative hemoglobin, the predicted hematocrit on cardiopulmonary bypass is greater than 33% (hemoglobin concentration of 110 g/L) or less than 18% (hemoglobin concentration of 60 g/L)

Sponsors & Collaborators

• Nadine Shehata: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Health Canada: collaborator

Study Sites (8)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

Location

Alberta Health Services

Edmonton, Alberta, T6G2B7, Canada

Location

St. Boniface General Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

St Michael's Hospital

Toronto, Ontario, M5B1W8, Canada

Location

Related Publications (1)

• Carson JL, Stanworth SJ, Dennis JA, Fergusson DA, Pagano MB, Roubinian NH, Turgeon AF, Valentine S, Trivella M, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2025 Oct 20;10(10):CD002042. doi: 10.1002/14651858.CD002042.pub6.

  PMID: 41114449 DERIVED

Study Officials

• Nadine Shehata, MD

  Li Ka Shing Knowledge Institute, Mount Sinai Hospital

  PRINCIPAL INVESTIGATOR

• David Mazer, MD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator-Sponsor

Study Record Dates

• First Submitted: November 30, 2011
• First Posted: December 2, 2011
• Study Start: January 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: February 21, 2013

Record last verified: 2013-02

Locations

US (1); CA (7)