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DisorderTRICS-IVNCT04754022

Transfusion Requirements in Younger Patients Undergoing Cardiac Surgery

A study testing Restrictive Transfusion Strategy and Liberal transfusion strategy in people with Disorder and Heart, run by Unity Health Toronto at 54 sites in 16 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

TRICS-IV is an international, multi-centre, open-label randomized controlled trial of two commonly used transfusion strategies in moderate to high risk patients who are 65 years of age or younger undergoing cardiac surgery on cardiopulmonary bypass, using a superiority trial design. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Disorder, Heart, Postoperative
What is being tested?
Restrictive Transfusion Strategy and Liberal transfusion strategy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,440 participants
Where
54 sitesin 16 countries
Study dates
1 Nov 2021to Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥18 and ≤65 years of age
  • Planned cardiac surgery using cardiopulmonary bypass
  • Informed consent obtained
  • Preoperative European System for Cardiac Operative Risk Evaluation (EuroSCORE I) of 6 or more

Who cannot join

  • Patients who refuse participation
  • Patients who are unable to receive or who refuse blood products
  • Patients who are involved in a preoperative autologous pre-donation program
  • Patients who are having a heart transplant or having surgery solely for an insertion of a ventricular assist device
  • Pregnancy or lactation (a negative pregnancy test must be obtained prior to randomization for women of childbearing potential)

Trial locations and contacts

54 sites in 16 countries. Contact the study team or a site near you to ask about taking part.

David Mazer, MD contact

416-864-5825

David.Mazer@unityhealth.to

54 sites in 16 countries

Canada15 sites, 14 recruiting

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2B7

    Wing Lam, MD, 780-407-8861, wingying@ualberta.ca

    Wing Lam, MD

    Recruiting

  • Health Sciences North Research Institute

    Greater Sudbury, Ontario, P3E 5J1

    Eugene Leshchyshyn, MD, 416-856-8574, eugene.leshchyshyn@mail.utoronto.ca

    Eugene Leshchyshyn, MD

    Recruiting

  • Hamilton Health Sciences Centre / Hamilton General Hospital

    Hamilton, Ontario, L8L 2X2

    Richard Whitlock, 905-521-2100 ext. 40306, Richard.whitlock@phri.ca

    Richard Whitlock

    Recruiting

  • Interior Health Kelowna General Hospital

    Kelowna, British Columbia, V1Y 0C5

    Nick Kuzak, 250-808-3035, nick.kuzak@interiorhealth.ca

    Nick Kuzak

    Recruiting

  • Kingston Health Sciences Centre

    Kingston, Ontario, K7L 2V7

    Active, not recruiting

  • Montreal Heart Institute

    Montreal, Quebec, H1T 1C8

    Antoine Rochon, MD, 514-376-3330, antoine.rochon@icm-mhi.org

    Antoine Rochon, MD

    Recruiting

  • Centre hospitalier de l'Université de Montréal

    Montreal, Quebec, H2X 0C1

    François Carrier, 514-890-8444, francois.martin.carrier@umontreal.ca

    François Carrier

    Recruiting

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

    Matthew Cameron, MD, 514-340-8222, matthew.cameron@mcgill.ca

    Matthew Cameron, MD

    Recruiting

  • Hôpital Sacré-Cœur de Montréal

    Montreal, Quebec, H4J 1C5

    Hugues Jeanmart, MD, 514-338-2050, hugues.jeanmart@umontreal.ca

    Hugues Jeanmart, MD

    Recruiting

  • Institut universitaire de cardiologie et de pneumology de Québec - université Laval (IUCPQ-UL)

    Québec, Quebec, G1V 4G5

    Étienne J Couture, 418-656-8711 ext. 2641, etienne.couture.3@ulaval.ca

    Étienne J Couture

    Recruiting

  • Saint John Regional Hospitall

    Saint John, New Brunswick, E2L 4L2

    Craig Brown, 506-648-6102, cdbrown@nbnet.nb.ca

    Craig Brown

    Recruiting

  • Sunnybrook Health Sciences Center

    Toronto, Ontario, M4N 3M5

    Stephen Fremes, MD, 416-480-6100, stephen.fremes@sunnybrook.ca

    Stephen Fremes, MD

    Recruiting

  • St. Michael's Hospital, Unity Health Toronto

    Toronto, Ontario, M5B 1W8

    David Mazer, MD, 416-864-5825, david.mazer@unityhealth.to

    David Mazer, MD

    Recruiting

  • Toronto General Hospital

    Toronto, Ontario, M5G 2C4

    Matteo Parotto, MD, 416-430-5164, matteo.parotto@uhn.ca

    Matteo Parotto, MD

    Recruiting

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9

    Darren Mullane, MD, 604- 875-4304, Darren.mullane@vch.ca

    Darren Mullane, MD

    Recruiting

Other trials in Canada

Australia11 sites, 11 recruiting

  • Royal Adelaide Hospital

    Adelaide, Adelaide, 5000

    Kate Drummond, MD, 0412 517 816, Kate.Drummond@sa.gov.au

    Kate Drummond, MD

    Recruiting

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042

    Robert Baker, +61 8 8404 2015, rob.baker@sa.gov.au

    Robert Baker

    Recruiting

  • Royal Prince Alfred hospital

    Camperdown, New South Wales, 2050

    Paul Bannon, MD, 02 9515 6377, pgbannon@gmail.com

    Paul Bannon, MD

    Recruiting

  • Monash Health

    Clayton, Victoria, 3168

    Julian Smith, MD, + 61 3 8572 2563, Julian.smith@monash.edu

    Julian Smith, MD

    Recruiting

  • St Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065

    David Scott, MD, +61 3 9231 4253, David.SCOTT@svha.org.au

    David Scott, MD

    Recruiting

  • Austin Health

    Heidelberg, Victoria, 3084

    Raymond Hu, MD, 03 9496 3800, raymond.hu@austin.org.au

    Raymond Hu, MD

    Recruiting

  • Royal Melbourne Hospital

    Melbourne

    Alistair Royse, MD, 0418554135, Alistair.Royse@heartweb.com

    Alistair Royse, MD

    Recruiting

  • Alfred Hospital

    Prahran, 3181

    Paul Myles, MD, 90763176, p.myles@alfred.org.au

    Paul Myles, MD

    Recruiting

  • Prince of Wales Hospital

    Randwick, New South Wales, 2024

    Aine Duggan, MD, 0438 304 976, aineduggan@hotmail.com

    Aine Duggan, MD

    Recruiting

  • Gold Coast University Hospital

    Southport, Queensland, 4215

    Matthew Beech, MD, 0407233263, Matthew.Beech@health.qld.gov.au

    Matthew Beech, MD

    Recruiting

  • Westmead Hospital

    Westmead, New South Wales, 2145

    Stefan Dieleman, MD, 0406982659, jan.dieleman@health.nsw.gov.au

    Stefan Dieleman, MD

    Recruiting

Other trials in Australia

United Kingdom7 sites, 7 recruiting

  • Basildon University Hospitals-Mid and South Essex NHS Trust

    Basildon, Essex

    Kunal Waghmare, MD, 01268524900, kunal.waghmare@nhs.net

    Kunal Waghmare, MD

    Recruiting

  • University Hospitals Sussex NHS Foundation Trust

    Brighton, BN2 1ES

    Michael Lewis, MD, Michael.lewis22@nhs.net

    Michael Lewis, MD

    Recruiting

  • University Hospitals Bristol and Weston NHS Foundation Trust

    Bristol

    Ben Gibbison, MD, 07931568135, ben.gibbison@bristol.ac.uk

    Ben Gibbison, MD

    Recruiting

  • Royal Papworth Hospital NHS Foundation Trust.

    Cambridge

    Andrew klein, MD, (01223) 638185, andrew.klein@nhs.net

    Andrew klein, MD

    Recruiting

  • University Hospital Leicester

    Leicester, East Midlands, LE3 9QP

    Gavin Murphy, MD, +44 116 258 3054, gjm19@leicester.ac.uk

    Gavin Murphy, MD

    Recruiting

  • University Hospital Southampton Foundation Trust

    Southampton, Hampshire, SO16 6YD

    Paul Diprose, MD, 01722 711042, drpdiprose@gmail.com

    Paul Diprose, MD

    Recruiting

  • Manchester University NHS Foundation Trust

    Wythenshawe, M23 9QZ

    Seema Agarwal, MD, Seema.Agarwal@mft.nhs.uk

    Seema Agarwal, MD

    Recruiting

Other trials in United Kingdom

United States4 sites, 3 recruiting

  • The Cooper Health System

    Camden, New Jersey, 08103

    Ludmil Mitrev, MD, mitrev-ludmil@CooperHealth.edu

    Ludmil Mitrev, MD

    Recruiting

  • Columbia University

    New York, New York, 10032

    Aaron Mittel, MD, 212-305-9817, am4656@cumc.columbia.edu

    Aaron Mittel, MD

    Not yet recruiting

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

    Active, not recruiting

  • Maine Medical Center

    Portland, Maine, 04102

    Robert Kramer, MD, 207-662-2923, Robert.Kramer@mainehealth.org

    Robert Kramer, MD

    Recruiting

Other trials in United States

Colombia3 sites, 3 recruiting

  • Hospital Universitario San Ignacio

    Bogotá, 110231

    Edgar Rios, MD, egrios@husi.org.co

    Edgar Rios, MD

    Recruiting

  • Fundacion Abood Shaio

    Bogotá, 111111

    Mauricio Abello Sanchez, MD, 3103218780, mauricio.abellos@shaio.org

    Mauricio Abello Sanchez, MD

    Recruiting

  • Fundacion Cardioinfantil

    Bogotá

    Edgar Leiva, MD, +573108708827, edgarhernandez@lacardio.org

    Edgar Leiva, MD

    Recruiting

Other trials in Colombia

Spain3 sites, 3 recruiting

  • Hospital de la Santa Creu I Sant Pau

    Barcelona, Catalonia, 08025

    Ana Maria Caro, MD, 34 93 291 90 00, AGomezC@santpau.cat

    Ana Maria Gomez Caro, MD

    Recruiting

  • Hospital General Universitari de Valencia

    Valencia

    Joaquin Moreno-Pachon, MD, 630306333187554, jmorenopachon@gmail.com

    Joaquin Moreno-Pachon, MD

    Recruiting

  • Hospital Universitario La Fe Valencia

    Valencia

    Paula Garcia, MD, 0034669344529, paulayayu@gmail.com

    Paula Carmona Garcia, MD

    Recruiting

Other trials in Spain

Switzerland2 sites, 2 recruiting

  • University Hospital Basel

    Basel, 4054

    Daniel Bolliger, MD, +41 61 328 64 23, Daniel.bolliger@usb.ch

    Daniel Bolliger, MD

    Recruiting

  • Inselspital, University Hospital Bern, University of Bern

    Bern, Canton of Bern, 3010

    Gabor Erdoes, MD, 00 41 31 632 2726, gabor.erdoes@insel.ch

    Gabor Erdoes, MD

    Recruiting

Other trials in Switzerland

Egypt1 site

  • Nasr City Health Insurance Hospital

    Naşr, Cairo Governorate, 4450010

    Active, not recruiting

Other trials in Egypt

Greece1 site, 1 recruiting

  • Democritus University of Thrace

    Alexandroupoli, Evros, 68100

    Dimos Karangelis, MD, (0030)6944786480, dimoskaragel@yahoo.com

    Dimos Karangelis, MD

    Recruiting

Other trials in Greece

India1 site, 1 recruiting

  • EPIC Hospital

    Ahmedabad, Gujarat, 380060

    Chirag Mehta, MD, +91 9825016956, chiragdr69@gmail.com

    Chirag Mehta, MD

    Recruiting

Other trials in India

Namibia1 site

  • Windhoek Central Hospital

    Windhoek, Khomas Region, 0000

    Active, not recruiting
Nepal1 site, 1 recruiting

  • Shahid Gangalal National Heart Center

    Kathmandu, Kathmandu, 44600

    Ashish Amatya, MD, +9779851004532, amatyaashish151@gmail.com

    Ashish Amatya, MD

    Recruiting

Other trials in Nepal

Romania1 site, 1 recruiting

  • Emergency Institute of Cardiovascular Diseases

    Bucharest, Romania, 022322

    Daniela Filipescu, MD, 004-0213026736, 1danielaf@gmail.com

    Daniela Filipescu, MD

    Recruiting

Other trials in Romania

Russia1 site

  • Saint-Petersburg State University Hospital

    Saint Petersburg

    Suspended

Other trials in Russia

Singapore1 site, 1 recruiting

  • National Heart Centre

    Singapore

    Hwang Chih, MD, +65 6321 4220, hwang.nian.chih@singhealth.com.sg

    Hwang Chih, MD

    Recruiting

Other trials in Singapore

South Africa1 site

  • Charlotte Maxeke Johannesburg Academic Hospital

    Johannesburg, Gauteng, 2196

    Active, not recruiting

Other trials in South Africa

About this study

Official title: An International, Multi-centre, Randomized Controlled Trial to Assess Transfusion Thresholds in Younger Patients Undergoing Cardiac Surgery

TRICS-IV is an international, multi-centre, open-label randomized controlled trial of two commonly used transfusion strategies in moderate to high risk patients who are 65 years of age or younger undergoing cardiac surgery on cardiopulmonary bypass, using a superiority trial design.

Being tested
Restrictive Transfusion Strategy, Liberal transfusion strategy
Keywords
Cardiac Surgery, Transfusion
Medical subject headings
Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Restrictive Transfusion StrategyOther

    Patients will receive a RBC transfusion if their Hb concentration is <75 g/L (<7.5 g/dL; <4.7mmol/L) intraoperatively and/or postoperatively.

  • Liberal transfusion strategyOther

    Patients will receive a RBC transfusion if their Hb concentration is <95 g/L (<9.5 g/dL; <5.9mmol/L) intraoperatively, or postoperatively in the ICU; and/or <85 g/L (< 8.5 g/dL; <5.3mmol/L) on the ward.

Study groups in NCT04754022
Study groupRoleWhat they receive
Restrictive Transfusion StrategyActive comparatorPatients will receive a RBC transfusion if their Hb concentration is <75 g/L (<7.5 g/dL; <4.7mmol/L) intraoperatively and/or postoperatively.
Receives: Other: Restrictive Transfusion Strategy
Liberal Transfusion StrategyActive comparatorPatients will receive a RBC transfusion if their Hb concentration is <95 g/L (<9.5 g/dL; <5.9mmol/L) intraoperatively, or postoperatively in the ICU; and/or <85 g/L (< 8.5 g/dL; <5.3mmol/L) on the ward.
Receives: Other: Liberal transfusion strategy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite score of any one of the following events occurring 6 months after cardiac surgery: (1) all-cause mortality; (2) myocardial infarction; (3) new onset renal failure requiring dialysis; or (4) new focal neurological deficit (stroke).

    Any of all-cause mortality, myocardial infarction, new onset renal failure requiring dialysis, or new focal neurological deficit (stroke).

    Measured: Within 6 months after cardiac surgery.

Secondary outcomes (13)

  1. Incidence of each individual component of the primary outcome: all-cause mortality, myocardial infarction, new onset renal failure requiring dialysis, and new focal neurological deficit (stroke).

    Incidence of all-cause mortality, myocardial infarction, new onset renal failure requiring dialysis, and new focal neurological deficit (stroke).

    Measured: Within 6 months after cardiac surgery.

  2. Composite and individual all-cause mortality, myocardial infarction, new onset renal failure requiring dialysis, and new focal neurological deficit (stroke).

    Composite and individual incidence of all-cause mortality, myocardial infarction, new onset renal failure requiring dialysis, and new focal neurological deficit (stroke).

    Measured: Up to hospital discharge or after 28 days postoperatively, whichever comes first.

  3. Length of stay in the ICU and hospital.

    Length of stay in the ICU and hospital in days.

    Measured: Up to hospital discharge or after 28 days postoperatively, whichever comes first.

  4. Prolonged low output state.

    Defined as the need for two or more inotropes for 24 hours or more, intra-aortic balloon pump or ventricular assist device postoperatively.

    Measured: Up to hospital discharge or after 28 days postoperatively, whichever comes first.

  5. Duration of mechanical ventilation.

    Time on mechanical ventilation.

    Measured: Up to hospital discharge or after 28 days postoperatively, whichever comes first.

  6. Incidence of infection.

    Defined as septic shock with positive blood cultures; pneumonia defined as autopsy diagnosis or roentgenographic infiltrate and at least two out of three of the following criteria: fever, leukocytosis, and positive sputum culture; and/or deep sternal or leg wound infection requiring intravenous antibiotics and/or surgical debridement.

    Measured: Up to hospital discharge or after 28 days postoperatively, whichever comes first.

  7. Acute kidney injury.

    Defined by the Kidney Disease Improving Global Outcomes (KDIGO) clinical practice guideline - a 50% increase in serum creatinine within 1 week or a 26.5 mmol/L increase within 48 hours.

    Measured: Up to hospital discharge or after 28 days postoperatively, whichever comes first.

  8. Delirium.

    Confusion Assessment Method (CAM) or CAM-ICU (even on 1 occasion), or Intensive Care Delirium Screening Checklist (ICDSC) > 3, or 3D-CAM, or 4AT ≥4, or more than one dose of haloperidol or similar antipsychotic drug, or documented delirium by neurologist or neurosurgeon or psychiatrist consultation.

    Measured: Up to hospital discharge or after 28 days postoperatively, whichever comes first.

  9. Incidence of gut infarction.

    Confirmed by imaging (e.g. angiography), autopsy, or through surgical means.

    Measured: Up to hospital discharge or after 28 days postoperatively, whichever comes first.

  10. Hospital visits.

    Hospitalization and/or emergency visits and coronary revascularization after index procedure.

    Measured: Within 6 months after cardiac surgery.

  11. Transfusion requirements.

    The proportion of patients transfused and the number of blood products utilized (RBCs, plasma, platelets).

    Measured: Up to hospital discharge or after 28 days postoperatively, whichever comes first.

  12. Incidence of seizures.

    Generalized or focal tonic-clonic movements consistent with seizure; or electroencephalogram demonstrating epileptiform discharges; or diagnosis of seizures by neurologist or neurosurgeon consultation.

    Measured: Up to hospital discharge or after 28 days postoperatively, whichever comes first.

  13. Incidence of encephalopathy.

    Unexpected delayed awakening or severely altered mental status (unconscious despite no sedative medication for more than 5 days), or encephalopathy documented by neurologist or neurosurgeon or psychiatrist consultation.

    Measured: Up to hospital discharge or after 28 days postoperatively, whichever comes first.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2021
  2. Study start1 Nov 2021
  3. Primary completionDec 2025 (estimated)
  4. Study completionJun 2026 (estimated)

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,440 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04754022
Sponsor's protocol ID
TRICS-IV
Acronym
TRICS-IV
Status last verified
Nov 2024
First submitted
9 Feb 2021
Last updated
21 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 41114449

  • 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.

    PubMed 34932836

Questions about this trial

What is this clinical trial studying?

A study testing Restrictive Transfusion Strategy and Liberal transfusion strategy in people with Disorder and Heart, run by Unity Health Toronto at 54 sites in 16 countries.

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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in Canada, Australia, United Kingdom, United States, Colombia and 11 more countries. 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.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact David Mazer, MD (416-864-5825, David.Mazer@unityhealth.to), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite score of any one of the following events occurring 6 months after cardiac surgery: (1) all-cause mortality; (2) myocardial infarction; (3) new onset renal failure requiring dialysis; or (4) new focal neurological deficit (stroke). (time frame: Within 6 months after cardiac 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 NCT04754022, which also lists 2 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 21 Nov 2024.

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