TRACS STUDY: Transfusion Requirements After Cardiac Surgery

The recruitment status of this study is unknown because the information has not been verified recently.

Verified November 2009 by Instituto do Coracao.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Instituto do Coracao

ClinicalTrials.gov Identifier:

NCT01021631

First received: November 27, 2009

Last updated: NA

Last verified: November 2009

History: No changes posted

Purpose

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.

Condition	Intervention	Phase
Cardiac Surgery	Other: Red blood cell transfusion	Phase 3

Study Type:	Interventional
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)

Resource links provided by NLM:

MedlinePlus related topics: Blood Transfusion and Donation Heart Surgery

U.S. FDA Resources

Further study details as provided by Instituto do Coracao:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	500
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)

Arms	Assigned Interventions
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. Other Names: Red blood cells Transfusion Liberal Cardiac surgery
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. Other Names: Red blood cells Transfusion Restrictive Cardiac surgery

Arms

Assigned Interventions

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.

Other Names:

Red blood cells
Transfusion
Liberal
Cardiac surgery

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.

Other Names:

Red blood cells
Transfusion
Restrictive
Cardiac surgery

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01021631

Contacts

Contact: Ludhmila A Hajjar, MD	55-11-93194401	ludhmila@terra.com.br
Contact: Filomena R Galas, MD, PhD	55-11-93190441	filomenagalas@hotmail.com

Locations

Brazil
InCor - Faculdade de Medicina da Universidade de Sao Paulo	Recruiting
Sao Paulo, SP, Brazil, 05403000
Contact: Ludhmila A Hajjar, MD 55-11-93194401 ludhmila@terra.com.br
Contact: Filomena R Galas, MD, PhD 55-11-93190441 filomenagalas@hotmail.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

Sponsors and Collaborators

Instituto do Coracao

Investigators

Principal Investigator:

Ludhmila A Hajjar, MD

InCor - HCFMUSP

More Information

Publications:

Hajjar LA, Auler Junior JO, Santos L, Galas F. Blood tranfusion in critically ill patients: state of the art. Clinics (Sao Paulo). 2007 Aug;62(4):507-24. Review.

Auler JO Jr, Galas F, Hajjar L, Santos L, Carvalho T, Michard F. Online monitoring of pulse pressure variation to guide fluid therapy after cardiac surgery. Anesth Analg. 2008 Apr;106(4):1201-6, table of contents.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hajjar LA, Vincent JL, Galas FR, Nakamura RE, Silva CM, Santos MH, Fukushima J, Kalil Filho R, Sierra DB, Lopes NH, Mauad T, Roquim AC, Sundin MR, Leão WC, Almeida JP, Pomerantzeff PM, Dallan LO, Jatene FB, Stolf NA, Auler JO Jr. Transfusion requirements after cardiac surgery: the TRACS randomized controlled trial. JAMA. 2010 Oct 13;304(14):1559-67.

Responsible Party:	Jose Otavio Costa Auler Jr, InCor - HCFMUSP
ClinicalTrials.gov Identifier:	NCT01021631 History of Changes
Other Study ID Numbers:	Transfusion
Study First Received:	November 27, 2009
Last Updated:	November 27, 2009
Health Authority:	Brazil: Ethics Committee

Keywords provided by Instituto do Coracao:

Cardiac surgery
Strategies of transfusion
Red blood cells

Liberal
Restrictive
Anemia

ClinicalTrials.gov processed this record on May 16, 2013

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