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

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00318227
• Other study ID #: R-03-043
• Secondary ID: 9540
• Status: Completed
• Phase: N/A
• First received: April 24, 2006
• Last updated: August 25, 2017
• Start date: June 21, 2004
• Est. completion date: February 23, 2010

Study information

• Verified date: August 2017
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: February 23, 2010
• Est. primary completion date: April 21, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Coronary Artery Bypass Surgery

Intervention

Procedure:
• Blood Transfusion
Blood transfusion will be administered when the transfusion trigger is met.

Locations

Country	Name	City	State
Canada	London Health Sciences Centre - University Campus	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distance walked during 6 minute walk test at 5 weeks postop		5 weeks
Secondary	renal failure, hospital length of stay, Quality of Life questionnaire		during hospital stay