TRACS STUDY: Transfusion Requirements After Cardiac Surgery (TRACS)
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|ClinicalTrials.gov Identifier: NCT01021631|
Recruitment Status : Unknown
Verified November 2009 by Instituto do Coracao.
Recruitment status was: Recruiting
First Posted : November 30, 2009
Last Update Posted : November 30, 2009
|Condition or disease||Intervention/treatment||Phase|
|Cardiac Surgery||Other: Red blood cell transfusion||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Transfusion Requirements After Cardiac Surgery: a Randomized Controlled Clinical Trial (TRACS STUDY)|
|Study Start Date :||February 2009|
|Estimated Primary Completion Date :||February 2010|
|Estimated Study Completion Date :||April 2010|
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.
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|