NCT01021631

TRACS STUDY: Transfusion Requirements After Cardiac Surgery

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Instituto do Coracao · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Cardiac Surgery

Interventions

Type	Name	Description
OTHER	Red blood cell transfusion	Red blood cell (RBC) transfusion will be given when hematocrit fall below 30% since intraoperative until the discharge of intensive care unit. Following administration of the 1 RBC unit, a repeat hematocrit is performed;if a patient's hematocrit is 30% or higher, no additional transfusion is necessary.
OTHER	Red blood cell transfusion	Red blood cell (RBC) transfusion will be only given when hematocrit fall below 24% since intraoperative until the discharge of intensive care unit. Following administration of the 1 RBC unit, a repeat hematocrit is performed;if a patient's hematocrit is 24% or higher, no additional transfusion is necessary.

Timeline

• Start date: 2009-02-01
• Primary completion: 2010-02-01
• Completion: 2010-04-01
• First posted: 2009-11-30
• Last updated: 2009-11-30

Locations

1 site across 1 country: Brazil