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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Lawson Health Research Institute.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00318227
First received: April 24, 2006
Last updated: April 15, 2009
Last verified: April 2009
History of Changes
  Purpose

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

Condition Intervention
Anemia
Coronary Artery Bypass Surgery
 Procedure: Blood Transfusion

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Evaluation of a Liberal Versus Restrictive Blood Transfusion Strategy in Elderly Patients Following Coronary Bypass or Aortic Valve Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Distance walked during 6 minute walk test at 5 weeks postop [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • renal failure, hospital length of stay, Quality of Life questionnaire [ Time Frame: during hospital stay ] [ Designated as safety issue: No ]

Estimated Enrollment: 74
Study Start Date: June 2005
Estimated Study Completion Date: May 2009
Estimated Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   70 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00318227

Contacts
Contact: Mary Lee Myers, MD FRCSC 519-685-8500 ext 33479 ml.myers@lhsc.on.ca
Contact: Robin Varghese, MD MS FRCSC 519-685-8500 ext 33479 rvarghe2@uwo.ca

Locations
Canada, Ontario
London Health Sciences Centre - University Campus Recruiting
London, Ontario, Canada, N6A 5A5
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Dr. M.L. Myers, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00318227     History of Changes
Other Study ID Numbers: R-03-043, 9540
Study First Received: April 24, 2006
Last Updated: April 15, 2009
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
Postoperative care
Cardiac Surgery
Blood Transfusion

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on May 16, 2013