Randomized Trial of a Liberal Versus a Restrictive Transfusion Strategy in Elderly Cardiac Surgery Patients

Evaluation of a Liberal Versus Restrictive Blood Transfusion Strategy in Elderly Patients Following Coronary Bypass or Aortic Valve Surgery

The purpose of this study is to determine whether a less restrictive strategy of red blood cell transfusion in elderly patients following coronary bypass surgery results in enhanced postoperative recovery as determined by quality of life assessment, exercise tolerance and clinical outcomes.

Two postoperative transfusion strategies:

1. Liberal - transfused when Hgb is <100g/L
2. Restrictive - transfused when Hgb is <70g/L

Study Overview

• Status: Completed
• Conditions: Anemia; Coronary Artery Bypass Surgery
• Intervention / Treatment: Procedure: Blood Transfusion

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • London Health Sciences Centre - University Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years to 90 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients >=70 years of age undergoing non-emergency coronary artery bypass surgery
• Initial postoperative hemoglobin level 70-90g/L

Exclusion Criteria:

• Patients who are unable to provide informed consent in English
• Patients with preoperative hemoglobin concentrations <100g/L
• Patients who require emergency re-operation
• Patients with intraoperative or postoperative bleeding diathesis
• Patients with postoperative clinical instability (eg. low output state)
• Patients in whom insertion of an intra-aortic balloon pump is required

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Liberal Red cell transfusion arm; Transfusion if Hgb <100g/L	Procedure: Blood Transfusion; Blood transfusion will be administered when the transfusion trigger is met.
Active Comparator: Restrictive Red Cell transfusion; Transfusion if Hgb <70g/L	Procedure: Blood Transfusion; Blood transfusion will be administered when the transfusion trigger is met.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Distance walked during 6 minute walk test at 5 weeks postop	5 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
renal failure, hospital length of stay, Quality of Life questionnaire	during hospital stay

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Investigators: Principal Investigator: Mary Lee Myers, MD FRCSC, London Health Sciences Centre/University of Western Ontario; Principal Investigator: Robin Varghese, MD MS FRCSC, London Health Sciences Centre/University of Western Ontario

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2004
• Primary Completion (Actual): April 21, 2009
• Study Completion (Actual): February 23, 2010

Study Registration Dates

• First Submitted: April 24, 2006
• First Submitted That Met QC Criteria: April 24, 2006
• First Posted (Estimate): April 26, 2006

Study Record Updates

• Last Update Posted (Actual): August 28, 2017
• Last Update Submitted That Met QC Criteria: August 25, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Blood Transfusion; Postoperative care; Cardiac Surgery
• Other Study ID Numbers: R-03-043; 9540 (Other Identifier: CTEP)