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OpenTrials
Completed

NCT Number: NCT00318227

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

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

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Key information

Conditions

Anemia Coronary Artery Bypass Surgery Hematologic Diseases Hemic and Lymphatic Diseases

Age range

70 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

London Health Sciences Centre - University Campus

London, Ontario, N6A 5A5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood Transfusion

Procedure

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

Primary outcomes

  1. Distance walked during 6 minute walk test at 5 weeks postop

    Time frame: 5 weeks

Secondary outcomes

  1. renal failure, hospital length of stay, Quality of Life questionnaire

    Time frame: during hospital stay

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2009
Study completion
2010
First posted
Apr 26, 2006
Registry last updated
Aug 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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