TRACS STUDY: Transfusion Requirements After Cardiac Surgery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cardiac Surgery

Intervention / Treatment
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* Other: Red blood cell transfusion
* Other: Red blood cell transfusion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Liberal Transfusion Strategy<br>Liberal Group - transfusion when hematocrit is lower than 30% | Other: Red blood cell transfusion<br>* 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.<br>* Other names: Cardiac surgery;|
| Active Comparator: Restrictive Transfusion Strategy<br>Restrictive Group - transfusion when hematocrit is lower than 24% | Other: Red blood cell transfusion<br>* 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.<br>* Other names: Cardiac surgery;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac surgery, Strategies of transfusion, Red blood cells, Liberal, Restrictive, Anemia