TRACS STUDY: Transfusion Requirements After Cardiac Surgery

Instituto do Coracao

Status and phase: Unknown; Phase 3

Conditions: Cardiac Surgery

Treatments: Other: Red blood cell transfusion

Study type: Interventional

Funder types: Other

Identifiers

NCT01021631

Transfusion

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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500 participants in 2 patient groups

Liberal Transfusion Strategy

Active Comparator group

Description:

Liberal Group - transfusion when hematocrit is lower than 30%

Treatment:

Other: Red blood cell transfusion

Other: Red blood cell transfusion

Restrictive Transfusion Strategy

Active Comparator group

Description:

Restrictive Group - transfusion when hematocrit is lower than 24%

Treatment:

Other: Red blood cell transfusion

Other: Red blood cell transfusion