TRACS STUDY: Transfusion Requirements After Cardiac Surgery

Phase 3

• Conditions: Cardiac Surgery
• Interventions: Other: Red blood cell transfusion

• Registration Number: NCT01021631
• Lead Sponsor: Instituto do Coracao

Brief 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.

Study Timeline

• Study Start: 2009-02
• Status Verified: 2009-11
• Study First Submitted: 2009-11-27
• Study First Submitted QC: 2009-11-27
• Last Update Submitted: 2009-11-27
• Study First Posted: 2009-11-30
• Last Update Posted: 2009-11-30
• Primary Completion: 2010-02
• Study Completion: 2010-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• All elective primary and redo adult cardiac surgical patients for coronary artery bypass grafting, valve procedure or combined procedures
• Adults patients
• Written informed consent

Exclusion Criteria

• Age less than 18 years
• Transplant procedures
• Emergency procedures
• Aortic repairs
• Congenital procedures
• Previous anemia (hemoglobin lower than 10 g/dL)
• Previous thrombocytopenia (platelet number lower than 100.000/mm3)
• Previous known coagulopathy
• Pregnancy
• Those unable to receive blood transfusion
• Patients who refused participation in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liberal Transfusion Strategy	Red blood cell transfusion	Liberal Group - transfusion when hematocrit is lower than 30%
Restrictive Transfusion Strategy	Red blood cell transfusion	Restrictive Group - transfusion when hematocrit is lower than 24%

Primary Outcome Measures

Name	Time	Method
The primary purpose of this study is to compare clinical outcomes after cardiac surgery in patients submitted to different strategies of red blood cell transfusion	30 days after surgery

Secondary Outcome Measures

Name	Time	Method
To compare length of stay in ICU, length of stay in Hospital, health-related quality of life, hospital costs and mortality between groups.	3 months

Trial Locations

Locations (1)

InCor - Faculdade de Medicina da Universidade de Sao Paulo; 🇧🇷 Sao Paulo, SP, Brazil