NCT00318227

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 21, 2004

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

April 24, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 26, 2006

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 21, 2009

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2010

Completed
Last Updated

August 28, 2017

Status Verified

August 1, 2017

Enrollment Period

4.8 years

First QC Date

April 24, 2006

Last Update Submit

August 25, 2017

Conditions

AnemiaCoronary Artery Bypass Surgery

Keywords

Postoperative careCardiac SurgeryBlood Transfusion

Outcome Measures

Primary Outcomes (1)

  • Distance walked during 6 minute walk test at 5 weeks postop

    5 weeks

Secondary Outcomes (1)

  • renal failure, hospital length of stay, Quality of Life questionnaire

    during hospital stay

Study Arms (2)

Liberal Red cell transfusion arm

ACTIVE COMPARATOR

Transfusion if Hgb \<100g/L

Procedure: Blood Transfusion

Restrictive Red Cell transfusion

ACTIVE COMPARATOR

Transfusion if Hgb \<70g/L

Procedure: Blood Transfusion

Interventions

Blood TransfusionPROCEDURE

Blood transfusion will be administered when the transfusion trigger is met.

Liberal Red cell transfusion armRestrictive Red Cell transfusion

Eligibility Criteria

Age70 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sciences Centre - University Campus

London, Ontario, N6A 5A5, 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: 41114449DERIVED

MeSH Terms

Conditions

Anemia

Interventions

Blood Transfusion

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2006

First Posted

April 26, 2006

Study Start

June 21, 2004

Primary Completion

April 21, 2009

Study Completion

February 23, 2010

Last Updated

August 28, 2017

Record last verified: 2017-08

Locations

CA(1)