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TRACS STUDY: Transfusion Requirements After Cardiac Surgery

NCT ID: NCT01021631

Last Updated: 2009-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2010-04-30

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.

Conditions

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Cardiac Surgery

Keywords

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Cardiac surgery Strategies of transfusion Red blood cells Liberal Restrictive Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Liberal Transfusion Strategy

Liberal Group - transfusion when hematocrit is lower than 30%

Group Type ACTIVE_COMPARATOR

Red blood cell transfusion

Intervention Type OTHER

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.

Restrictive Transfusion Strategy

Restrictive Group - transfusion when hematocrit is lower than 24%

Group Type ACTIVE_COMPARATOR

Red blood cell transfusion

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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Red blood cells Transfusion Liberal Cardiac surgery Red blood cells Transfusion Restrictive Cardiac surgery

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto do Coracao

OTHER_GOV

Sponsor Role lead

Responsible Party

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InCor - HCFMUSP

Principal Investigators

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Ludhmila A Hajjar, MD

Role: PRINCIPAL_INVESTIGATOR

InCor - HCFMUSP

Locations

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InCor - Faculdade de Medicina da Universidade de Sao Paulo

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Ludhmila A Hajjar, MD

Role: CONTACT

Phone: 55-11-93194401

Email: [email protected]

Filomena R Galas, MD, PhD

Role: CONTACT

Phone: 55-11-93190441

Email: [email protected]

Facility Contacts

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Ludhmila A Hajjar, MD

Role: primary

Filomena R Galas, MD, PhD

Role: backup

References

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Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5.

Reference Type DERIVED
PMID: 34932836 (View on PubMed)

Nakamura RE, Vincent JL, Fukushima JT, de Almeida JP, Franco RA, Lee Park C, Osawa EA, Pinto Silva CM, Costa Auler JO Jr, Landoni G, Barbosa Gomes Galas FR, Filho RK, Hajjar LA. A liberal strategy of red blood cell transfusion reduces cardiogenic shock in elderly patients undergoing cardiac surgery. J Thorac Cardiovasc Surg. 2015 Nov;150(5):1314-20. doi: 10.1016/j.jtcvs.2015.07.051. Epub 2015 Jul 26.

Reference Type DERIVED
PMID: 26318355 (View on PubMed)

Galas FR, Almeida JP, Fukushima JT, Osawa EA, Nakamura RE, Silva CM, de Almeida EP, Auler JO, Vincent JL, Hajjar LA. Blood transfusion in cardiac surgery is a risk factor for increased hospital length of stay in adult patients. J Cardiothorac Surg. 2013 Mar 26;8:54. doi: 10.1186/1749-8090-8-54.

Reference Type DERIVED
PMID: 23531208 (View on PubMed)

Hajjar LA, Almeida JP, Fukushima JT, Rhodes A, Vincent JL, Osawa EA, Galas FR. High lactate levels are predictors of major complications after cardiac surgery. J Thorac Cardiovasc Surg. 2013 Aug;146(2):455-60. doi: 10.1016/j.jtcvs.2013.02.003. Epub 2013 Mar 15.

Reference Type DERIVED
PMID: 23507124 (View on PubMed)

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, Leao 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. doi: 10.1001/jama.2010.1446.

Reference Type DERIVED
PMID: 20940381 (View on PubMed)

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. doi: 10.1590/s1807-59322007000400019.

Reference Type BACKGROUND
PMID: 17823715 (View on PubMed)

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. doi: 10.1213/01.ane.0000287664.03547.c6.

Reference Type BACKGROUND
PMID: 18349193 (View on PubMed)

Carson JL, Stanworth SJ, Dennis JA, Fergusson DA, Pagano MB, Roubinian NH, Turgeon AF, Valentine S, Trivella M, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2025 Oct 20;10:CD002042. doi: 10.1002/14651858.CD002042.pub6.

Reference Type DERIVED
PMID: 41114449 (View on PubMed)

Other Identifiers

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Transfusion

Identifier Type: -

Identifier Source: org_study_id