Transfusion Requirements in Younger Patients Undergoing Cardiac Surgery

NCT04754022 | Recruiting DMC

• 1 other identifier: TRICS-IV
• Study Type: interventional
• Target: 1,440
• Locations: 16 countries
• Sites: 54

Brief 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.

Conditions

Disorder; Heart; Postoperative; Cardiac Surgery

Keywords

Cardiac Surgery; Transfusion

Outcome Measures

Primary Outcomes (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).

  Within 6 months after cardiac surgery.

Secondary Outcomes (13)

• 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).

  Within 6 months after cardiac surgery.

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

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

• Length of stay in the ICU and hospital.

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

• Prolonged low output state.

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

• Duration of mechanical ventilation.

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

Study Arms (2)

Restrictive Transfusion Strategy

ACTIVE COMPARATOR

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.

Other: Restrictive Transfusion Strategy

Liberal Transfusion Strategy

ACTIVE COMPARATOR

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.

Other: Liberal transfusion strategy

Interventions

Restrictive Transfusion Strategy OTHER

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.

Restrictive Transfusion Strategy

Liberal transfusion strategy OTHER

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.

Liberal Transfusion Strategy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (54)

Maine Medical Center

Portland, Maine, 04102, United States

RECRUITING

The Cooper Health System

Camden, New Jersey, 08103, United States

RECRUITING

Columbia University

New York, New York, 10032, United States

NOT YET RECRUITING

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

ACTIVE NOT RECRUITING

Royal Adelaide Hospital

Adelaide, Adelaide, 5000, Australia

RECRUITING

Royal Prince Alfred hospital

Camperdown, New South Wales, 2050, Australia

RECRUITING

Prince of Wales Hospital

Randwick, New South Wales, 2024, Australia

RECRUITING

Westmead Hospital

Westmead, New South Wales, 2145, Australia

RECRUITING

Gold Coast University Hospital

Southport, Queensland, 4215, Australia

RECRUITING

Flinders Medical Centre

Bedford Park, South Australia, 5042, Australia

RECRUITING

Monash Health

Clayton, Victoria, 3168, Australia

RECRUITING

St Vincent's Hospital Melbourne

Fitzroy, Victoria, 3065, Australia

RECRUITING

Austin Health

Heidelberg, Victoria, 3084, Australia

RECRUITING

Royal Melbourne Hospital

Melbourne, Australia

RECRUITING

Alfred Hospital

Prahran, 3181, Australia

RECRUITING

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

RECRUITING

Interior Health Kelowna General Hospital

Kelowna, British Columbia, V1Y 0C5, Canada

RECRUITING

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

RECRUITING

Saint John Regional Hospitall

Saint John, New Brunswick, E2L 4L2, Canada

RECRUITING

Health Sciences North Research Institute

Greater Sudbury, Ontario, P3E 5J1, Canada

RECRUITING

Hamilton Health Sciences Centre / Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

RECRUITING

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

ACTIVE NOT RECRUITING

Sunnybrook Health Sciences Center

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

St. Michael's Hospital, Unity Health Toronto

Toronto, Ontario, M5B 1W8, Canada

RECRUITING

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

RECRUITING

Centre hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 0C1, Canada

RECRUITING

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

RECRUITING

Hôpital Sacré-Cœur de Montréal

Montreal, Quebec, H4J 1C5, Canada

RECRUITING

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

Québec, Quebec, G1V 4G5, Canada

RECRUITING

Hospital Universitario San Ignacio

Bogotá, 110231, Colombia

RECRUITING

Fundacion Abood Shaio

Bogotá, 111111, Colombia

RECRUITING

Fundacion Cardioinfantil

Bogotá, Colombia

RECRUITING

Nasr City Health Insurance Hospital

Naşr, Cairo Governorate, 4450010, Egypt

ACTIVE NOT RECRUITING

Democritus University of Thrace

Alexandroupoli, Evros, 68100, Greece

RECRUITING

EPIC Hospital

Ahmedabad, Gujarat, 380060, India

RECRUITING

Windhoek Central Hospital

Windhoek, Khomas Region, 0000, Namibia

ACTIVE NOT RECRUITING

Shahid Gangalal National Heart Center

Kathmandu, Kathmandu, 44600, Nepal

RECRUITING

Emergency Institute of Cardiovascular Diseases

Bucharest, Romania, 022322, Romania

RECRUITING

Saint-Petersburg State University Hospital

Saint Petersburg, Russia

SUSPENDED

National Heart Centre

Singapore, Singapore

RECRUITING

Charlotte Maxeke Johannesburg Academic Hospital

Johannesburg, Gauteng, 2196, South Africa

ACTIVE NOT RECRUITING

Hospital de la Santa Creu I Sant Pau

Barcelona, Catalonia, 08025, Spain

RECRUITING

Hospital General Universitari de Valencia

Valencia, Spain

RECRUITING

Hospital Universitario La Fe Valencia

Valencia, Spain

RECRUITING

Inselspital, University Hospital Bern, University of Bern

Bern, Canton of Bern, 3010, Switzerland

RECRUITING

University Hospital Basel

Basel, 4054, Switzerland

RECRUITING

University Hospital Leicester

Leicester, East Midlands, LE3 9QP, United Kingdom

RECRUITING

Basildon University Hospitals-Mid and South Essex NHS Trust

Basildon, Essex, United Kingdom

RECRUITING

University Hospital Southampton Foundation Trust

Southampton, Hampshire, SO16 6YD, United Kingdom

RECRUITING

University Hospitals Sussex NHS Foundation Trust

Brighton, BN2 1ES, United Kingdom

RECRUITING

University Hospitals Bristol and Weston NHS Foundation Trust

Bristol, United Kingdom

RECRUITING

Royal Papworth Hospital NHS Foundation Trust.

Cambridge, United Kingdom

RECRUITING

Manchester University NHS Foundation Trust

Wythenshawe, M23 9QZ, United Kingdom

RECRUITING

Related Publications (2)

• 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: 41114449 DERIVED

• 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: 34932836 DERIVED

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• David Mazer, MD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

• Nadine Shehata, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Mazer, MD

CONTACT

416-864-5825; David.Mazer@unityhealth.to

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: February 15, 2021
• Study Start: November 1, 2021
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1); GR (1); RO (1); GB (7); US (4); CA (15); IN (1); SG (1); NE (1); EG (1); ZA (1); AU (11); CO (3); ES (3); CH (2); NA (1)