TRACS STUDY: Transfusion Requirements After Cardiac Surgery
Recruitment status was Recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Transfusion Requirements After Cardiac Surgery: a Randomized Controlled Clinical Trial (TRACS STUDY)|
- 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 [ Time Frame: 30 days after surgery ] [ Designated as safety issue: Yes ]
- To compare length of stay in ICU, length of stay in Hospital, health-related quality of life, hospital costs and mortality between groups. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2009|
|Estimated Study Completion Date:||April 2010|
|Estimated Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
Active Comparator: Liberal Transfusion Strategy
Liberal Group - transfusion when hematocrit is lower than 30%
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.
Active Comparator: Restrictive Transfusion Strategy
Restrictive Group - transfusion when hematocrit is lower than 24%
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01021631
|Contact: Ludhmila A Hajjar, MDfirstname.lastname@example.org|
|Contact: Filomena R Galas, MD, PhDemail@example.com|
|InCor - Faculdade de Medicina da Universidade de Sao Paulo||Recruiting|
|Sao Paulo, SP, Brazil, 05403000|
|Contact: Ludhmila A Hajjar, MD 55-11-93194401 firstname.lastname@example.org|
|Contact: Filomena R Galas, MD, PhD 55-11-93190441 email@example.com|
|Principal Investigator: Ludhmila A Hajjar, MD|
|Sub-Investigator: Filomena R Galas, MD, PhD|
|Sub-Investigator: Rosana E Nakamura, MD|
|Sub-Investigator: Carolina Silva, MD|
|Sub-Investigator: Paulo C Bueno, MD|
|Sub-Investigator: Roberto Kalil Filho, MD, PhD|
|Sub-Investigator: Jean-Louis Vincent, MD, PhD|
|Sub-Investigator: Jose Otavio C Auler Jr, MD, PhD|
|Sub-Investigator: Thais Mauad, MD, PhD|
|Principal Investigator:||Ludhmila A Hajjar, MD||InCor - HCFMUSP|