Cardiac SurgeryPhase 3TRACSNCT01021631
TRACS STUDY: Transfusion Requirements After Cardiac Surgery
A Phase 3 study testing Red blood cell transfusion in people with Cardiac Surgery, run by Instituto do Coracao at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- Red blood cell transfusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2009to Apr 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All elective primary and redo adult cardiac surgical patients for coronary artery bypass grafting, valve procedure or combined procedures
- Adults patients
- Written informed consent
Who cannot join
- Age less than 18 years
- Transplant procedures
- Emergency procedures
- Aortic repairs
- Congenital procedures
- Previous anemia (hemoglobin lower than 10 g/dL)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
InCor - Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, São Paulo, 05403000
Ludhmila A Hajjar, MD, 55-11-93194401, ludhmila@terra.com.br
Filomena R Galas, MD, PhD, 55-11-93190441, filomenagalas@hotmail.com
About this study
Official title: Transfusion Requirements After Cardiac Surgery: a Randomized Controlled Clinical Trial (TRACS STUDY)
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.
Read the 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.
- Conditions
- Cardiac Surgery
- Being tested
- Red blood cell transfusion
- Keywords
- Cardiac surgery, Strategies of transfusion, Red blood cells, Liberal, Restrictive, Anemia
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red blood cell transfusionOther
Also called Red blood cells, Transfusion, Liberal, Cardiac surgery
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.
Red blood cell transfusionOther
Also called Red blood cells, Transfusion, Restrictive, Cardiac surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Liberal Transfusion Strategy | Active comparator | Liberal Group - transfusion when hematocrit is lower than 30% Receives: Other: Red blood cell transfusion |
| Restrictive Transfusion Strategy | Active comparator | Restrictive Group - transfusion when hematocrit is lower than 24% Receives: Other: Red blood cell transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2009 (estimated)
- Study startFeb 2009
- Primary completionFeb 2010 (estimated)
- Study completionApr 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto do Coracao
- Sponsor type
- Other government
- Investigators
- Ludhmila A Hajjar, MD, Principal investigator, InCor - HCFMUSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01021631
- Sponsor's protocol ID
- Transfusion
- Acronym
- TRACS
- Status last verified
- Nov 2009
- First submitted
- 27 Nov 2009
- Last updated
- 30 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1590/s1807-59322007000400019.
PubMed 17823715Auler 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.
PubMed 18349193Carson 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.
PubMed 41114449Carson 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.
PubMed 34932836Nakamura 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.
PubMed 26318355Galas 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.
PubMed 23531208Hajjar 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.
PubMed 23507124Hajjar 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.
PubMed 20940381
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transfusion Requirements After Cardiac Surgery: a Randomized Controlled Clinical Trial (TRACS STUDY)
- ClinicalTrials.gov ID
- NCT01021631
- Acronym / sponsor ID
- TRACS / Transfusion
- Conditions
- Cardiac Surgery
- Keywords
- Cardiac surgery, Strategies of transfusion, Red blood cells, Liberal, Restrictive, Anemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Instituto do CoracaoOther government
- Study start
- Feb 2009
- Primary completion
- Feb 2010 (estimated)
- Study completion
- Apr 2010 (estimated)
- First posted
- 30 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liberal Transfusion Strategy | Active comparator | Other: Red blood cell transfusionLiberal Group - transfusion when hematocrit is lower than 30% |
| Restrictive Transfusion Strategy | Active comparator | Other: Red blood cell transfusionRestrictive Group - transfusion when hematocrit is lower than 24% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All elective primary and redo adult cardiac surgical patients for coronary artery bypass grafting, valve procedure or combined procedures
- Adults patients
- Written informed consent
Key exclusion criteria (11 listed)
- Age less than 18 years
- Transplant procedures
- Emergency procedures
- Aortic repairs
- Congenital procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Red blood cell transfusionAlso: Red blood cells, Transfusion, Liberal, Cardiac surgeryRed 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 | Liberal Transfusion Strategy |
| Red blood cell transfusionAlso: Red blood cells, Transfusion, Restrictive, Cardiac surgeryRed 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 | Restrictive Transfusion Strategy |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2009.
- Background: PubMed 17823715Hajjar 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.
- Background: PubMed 18349193Auler 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.
- Derived from this study: PubMed 41114449Carson 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.
- Derived from this study: PubMed 34932836Carson 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.
- Derived from this study: PubMed 26318355Nakamura 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.
- Derived from this study: PubMed 23531208Galas 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.
- Derived from this study: PubMed 23507124Hajjar 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.
- Derived from this study: PubMed 20940381Hajjar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ludhmila A Hajjar, MD principal investigator
InCor - HCFMUSP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Red blood cell transfusion in people with Cardiac Surgery, run by Instituto do Coracao at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ludhmila A Hajjar, MD (55-11-93194401, ludhmila@terra.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01021631, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2009.