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TRACS STUDY: Transfusion Requirements After Cardiac Surgery — TRACS  

Cardiac Surgery Clinical Trial

Official title:
Transfusion Requirements After Cardiac Surgery: a Randomized Controlled Clinical Trial (TRACS STUDY)

Clinical Trial Summary

Blood transfusion is related to worse outcomes and the triggers for red blood cells transfusion are not well defined in cardiac surgery. Retrospective studies in cardiac surgery do not show benefits of red blood cell transfusion in reduction of morbidity and mortality in cardiac surgery. There are no prospective studies comparing outcomes between restrictive or liberal strategy in cardiac surgery.This study is a double-blind randomized study comparing clinical outcomes between two strategies of transfusion in cardiac surgery - liberal or restrictive.

Clinical Trial Description

Blood transfusion is commonly performed in patients submitted to cardiac surgery. However, there are many studies reporting adverse effects of this intervention and final data on benefits are not available. There are no prospective studies in cardiac surgery regarding red blood cell transfusions requirements. There are retrospective studies in cardiac surgery suggesting worse outcomes including higher rates of mortality in patients submitted to red blood transfusion. Hematocrit levels around 30% are usually recommended not evidence based. Our purpose is to prospectively evaluate two strategies of transfusion in 500 patients submitted to elective cardiac surgery: a liberal strategy - patients receive blood transfusion when hematocrit is lower than 30% since the intraoperative period until the ICU discharge; a restrictive strategy - patients receive blood transfusion only when hematocrit is lower than 24%.

Clinical outcomes, costs and quality of life will be compared. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01021631
Study type Interventional
Source Instituto do Coracao
Contact Ludhmila A Hajjar, MD
Phone 55-11-93194401
Email ludhmila@terra.com.br
Status Recruiting
Phase Phase 3
Start date February 2009
Completion date April 2010
View Details
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