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

Not Applicable

Completed

• Conditions: Anemia; Coronary Artery Bypass Surgery
• Interventions: Procedure: Blood Transfusion

• Registration Number: NCT00318227
• Lead Sponsor: Lawson Health Research Institute

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06-21
• Study First Submitted: 2006-04-24
• Study First Submitted QC: 2006-04-24
• Study First Posted: 2006-04-26
• Primary Completion: 2009-04-21
• Study Completion: 2010-02-23
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-25
• Last Update Posted: 2017-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liberal Red cell transfusion arm	Blood Transfusion	Transfusion if Hgb \<100g/L
Restrictive Red Cell transfusion	Blood Transfusion	Transfusion if Hgb \<70g/L

Primary Outcome Measures

Name	Time	Method
Distance walked during 6 minute walk test at 5 weeks postop	5 weeks

Secondary Outcome Measures

Name	Time	Method
renal failure, hospital length of stay, Quality of Life questionnaire	during hospital stay

Trial Locations

Locations (1)

London Health Sciences Centre - University Campus; 🇨🇦 London, Ontario, Canada