NCT01021631

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2009

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 30, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

November 30, 2009

Status Verified

November 1, 2009

Enrollment Period

1 year

First QC Date

November 27, 2009

Last Update Submit

November 27, 2009

Conditions

Cardiac Surgery

Keywords

Cardiac surgeryStrategies of transfusionRed blood cellsLiberalRestrictiveAnemia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (2)

Liberal Transfusion Strategy

ACTIVE COMPARATOR

Liberal Group - transfusion when hematocrit is lower than 30%

Other: Red blood cell transfusion

Restrictive Transfusion Strategy

ACTIVE COMPARATOR

Restrictive Group - transfusion when hematocrit is lower than 24%

Other: Red blood cell transfusion

Interventions

Red blood cell transfusionOTHER

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.

Also known as: Red blood cells, Transfusion, Liberal, Cardiac surgery
Liberal Transfusion Strategy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All elective primary and redo adult cardiac surgical patients for coronary artery bypass grafting, valve procedure or combined procedures
  • Adults patients
  • Written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

InCor - Faculdade de Medicina da Universidade de Sao Paulo

São Paulo, São Paulo, 05403000, Brazil

RECRUITING

Related Publications (8)

  • 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.

    PMID: 17823715BACKGROUND

  • 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.

    PMID: 18349193BACKGROUND

  • 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(10):CD002042. doi: 10.1002/14651858.CD002042.pub6.

    PMID: 41114449DERIVED

  • 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.

    PMID: 34932836DERIVED

  • 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.

    PMID: 26318355DERIVED

  • 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.

    PMID: 23531208DERIVED

  • 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.

    PMID: 23507124DERIVED

  • 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.

    PMID: 20940381DERIVED

MeSH Terms

Conditions

Anemia

Interventions

Erythrocyte TransfusionErythrocyte CountBlood TransfusionCardiac Surgical Procedures

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Blood Component TransfusionBiological TherapyTherapeuticsBlood Cell CountCell CountCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHematologic TestsInvestigative TechniquesCell Physiological PhenomenaBlood Physiological PhenomenaCirculatory and Respiratory Physiological PhenomenaCardiovascular Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Study Officials

  • Ludhmila A Hajjar, MD

    InCor - HCFMUSP

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ludhmila A Hajjar, MD

CONTACT

55-11-93194401ludhmila@terra.com.br

Filomena R Galas, MD, PhD

CONTACT

55-11-93190441filomenagalas@hotmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 27, 2009

First Posted

November 30, 2009

Study Start

February 1, 2009

Primary Completion

February 1, 2010

Study Completion

April 1, 2010

Last Updated

November 30, 2009

Record last verified: 2009-11

Locations

BR(1)