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

NCT ID: NCT00318227

Last Updated: 2017-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-21

Study Completion Date

2010-02-23

Brief Summary

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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

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Conditions

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Anemia Coronary Artery Bypass Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Liberal Red cell transfusion arm

Transfusion if Hgb \<100g/L

Group Type ACTIVE_COMPARATOR

Blood Transfusion

Intervention Type PROCEDURE

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

Restrictive Red Cell transfusion

Transfusion if Hgb \<70g/L

Group Type ACTIVE_COMPARATOR

Blood Transfusion

Intervention Type PROCEDURE

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

Interventions

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Blood Transfusion

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

70 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mary Lee Myers, MD FRCSC

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Centre/University of Western Ontario

Robin Varghese, MD MS FRCSC

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Centre/University of Western Ontario

Locations

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London Health Sciences Centre - University Campus

London, Ontario, Canada

Site Status

Countries

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Canada

References

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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:CD002042. doi: 10.1002/14651858.CD002042.pub6.

Reference Type DERIVED
PMID: 41114449 (View on PubMed)

Other Identifiers

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9540

Identifier Type: -

Identifier Source: secondary_id

R-03-043

Identifier Type: -

Identifier Source: org_study_id

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