Transfusion Requirements in Cardiac Surgery III

NCT02042898 | Completed DMC

• 2 other identifiers: TRICSIII301852
• Study Type: interventional
• Target: 5,028
• Locations: 19 countries
• Sites: 74

Brief Summary

TRICS-III is an international, multi-centre, open-label randomized controlled trial of two commonly used transfusion strategies in high risk patients having cardiac surgery using a non-inferiority trial design.

Conditions

Disorder; Heart, Functional, Postoperative, Cardiac Surgery

Keywords

Cardiac Surgery; Transfusion

Outcome Measures

Primary Outcomes (1)

• Composite score of any one of the following: (1) all-cause mortality; (2) myocardial infarction; (3) new renal failure requiring dialysis; or (4) new focal neurological deficit

  Composite score of any one of the following events occurring during the index hospitalization (from the start of surgery until hospital discharge or postoperative day 28, whichever comes first): (1) all-cause mortality; (2) myocardial infarction; (3) new renal failure requiring dialysis; or (4) new focal neurological deficit

  Up to hospital discharge or postoperative day 28 (whichever occurs first)

Secondary Outcomes (21)

• Incidence of in-hospital all-cause mortality

  Up to hospital discharge or postoperative day 28 (whichever occurs first)

• Incidence of in-hospital myocardial infarction

  Up to hospital discharge or postoperative day 28 (whichever occurs first)

• Incidence of in-hospital new renal failure requiring dialysis

  Up to hospital discharge or postoperative day 28 (whichever occurs first)

• Incidence of in-hospital new focal neurological deficit

  Up to hospital discharge or postoperative day 28 (whichever occurs first)

• Length of stay in the ICU and hospital

  Up to hospital discharge or postoperative day 28 (whichever occurs first)

Study Arms (2)

Restrictive transfusion strategy

ACTIVE COMPARATOR

Restrictive transfusion strategy: patients will receive a red cell transfusion if their hemoglobin is \<75 g/L (\<7.5 g/dL;\<4.7mmol/L) intraoperatively and/or postoperatively

Other: Restrictive Transfusion Strategy

Liberal transfusion strategy

ACTIVE COMPARATOR

Liberal transfusion strategy: patients will receive a red cell transfusion if their hemoglobin concentration is \<95 g/L (\<9.5 g/dL\<5.9mmol/L) intraoperatively, or postoperatively in the intensive care unit; and/or \<85 g/L (\< 8.5 g/dL;\<5.3mmol/L) on the ward.

Other: Liberal transfusion strategy

Interventions

Restrictive Transfusion Strategy OTHER

Restrictive transfusion strategy

Liberal transfusion strategy OTHER

Liberal transfusion strategy

Eligibility Criteria

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

You may qualify if:

• Age 18 or older
• 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 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.)
• Patients who are unable to receive or who refuse blood products

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (74)

San Francisco VA Medical Center

San Francisco, California, 94121, United States

Location

Yale-New Haven Hospital

New Haven, Connecticut, 06510-3202, United States

Location

Maine Medical Center

Portland, Maine, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Durham Veterans Affairs Medical Center

Durham, North Carolina, 27705, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75235, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Michael E. DeBakey Veterans Affairs Medical Center

Houston, Texas, 77030, United States

Location

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

Royal North Shore Hospital

Sydney, New South Wales, 2065, Australia

Location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Flinders Medical Centre

Bedford Park, South Australia, 5042, Australia

Location

Monash Medical Centre

Clayton, Victoria, 3168, Australia

Location

St Vincent's Hospital, Melbourne

Fitzroy, Victoria, 3065, Australia

Location

Austin Hospital

Heidelberg, Victoria, 3084, Australia

Location

Cabrini Health

Malvern, Victoria, 3144, Australia

Location

Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Barwon Health (University Hospital Geelong)

Melbourne, Victoria, 3220, Australia

Location

Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

Hospital Unimed Rio (National Institute of Cardiology)

Rio de Janeiro, Brazil

Location

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

Location

University of Alberta

Edmonton, Alberta, T6G 2R3, Canada

Location

Kelowna General Hospital

Kelowna, British Columbia, V1Y 1T2, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1L7, Canada

Location

St Boniface Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Saint John Regional Hospital

Saint John, New Brunswick, E2L 4L4, Canada

Location

Health Sciences Centre (Memorial University)

St. John's, Newfoundland and Labrador, A1B 3X9, Canada

Location

QEII Health Science Centre

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

London Health Sciences Center

London, Ontario, N6G 2V4, Canada

Location

Southlake Regional Health Centre

Newmarket, Ontario, L3Y 2P9, Canada

Location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

St Michael's Hospital

Toronto, Ontario, M5B1W8, Canada

Location

University Health Network Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)

Chemin Sainte-Foy, Quebec, G1V 4G5, Canada

Location

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

SMBD Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Hôpital du Sacré-Cœur de Montréal

Montreal, Quebec, H4J 1C5, Canada

Location

Centre hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Location

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1G 2E8, Canada

Location

Shanghai Yodak Cardio-Thoracic Hospital

Shanghai, 200235, China

Location

Renji Hospital

Shanghai, China

Location

Instituto del Corazón de Bucaramanga

Bucaramanga, Santander Department, Colombia

Location

Clinica de Marly

Bogotá, Colombia

Location

Fundacion Cardioinfantil Instituto de Cardiologia

Bogotá, Colombia

Location

Fundación Clínica Shaio

Bogotá, Colombia

Location

Hospital De San Jose

Bogotá, Colombia

Location

Rigshospitalet - Copenhagen University Hospital

Copenhagen, 2100, Denmark

Location

Tanta University Hospital

Tanta, Egypt

Location

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

University Hospital Giessen

Giessen, Germany

Location

University of Thessaly

Volos, Greece

Location

Narayana Health

Bangalore, Karnataka, India

Location

SAL Hospital

Gujarat, 380054, India

Location

Sheba Medical Center

Ramat Gan, 5262100, Israel

Location

Tel Aviv Sourasky Medical Centre

Tel Aviv, 64239, Israel

Location

Institut Jantung Negara

Kuala Lampur, 50400, Malaysia

Location

Auckland City Hospital

Auckland, 1023, New Zealand

Location

Christchurch Hospital

Christchurch, 4710, New Zealand

Location

Dunedin Hospital

Dunedin, 9016, New Zealand

Location

Waikato Hospital

Hamilton, 3204, New Zealand

Location

Wellington Hospital

Wellington, 6021, New Zealand

Location

Emergency Institute for Cardiovascular Diseases

Târgu Mureş, Romania

Location

National Heart Centre Singapore

Singapore, Singapore

Location

University of KwaZulu-Natal

Durban, KwaZulu-Natal, 4041, South Africa

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Location

Hospital Ramón y Cajal

Madrid, Spain

Location

Consorcio Hospital General Universitario de Valencia

Valencia, 46014, Spain

Location

Instituto de Investigación Sanitaria Hospital Univ. & Politc. La Fe de Valencia

Valencia, 46026, Spain

Location

University Hospital Basel

Basel, 4056, Switzerland

Location

University Hospital Bern (Inselspital)

Bern, Switzerland

Location

Related Publications (8)

• 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

• Mistry N, Hare GMT, Shehata N, Kramer RS, Fawzy HF, Baker RA, Carmona P, Saczkowski R, Filipescu D, Alphonsus CS, Rochon A, Gregory AJ, Khanykin B, Leff JD, Mateo E, Karangelis D, Tellez JC, Saha T, Ko DT, Wijeysundera DN, Verma S, Mazer CD. Methemoglobin as a marker of acute anemic stress in cardiac surgery. iScience. 2023 Jul 20;26(8):107429. doi: 10.1016/j.isci.2023.107429. eCollection 2023 Aug 18.

  PMID: 37575193 DERIVED

• Sankar A, Rotstein AJ, Teja B, Carrier FM, Belley-Cote EP, Bolliger D, Saha T, Carmona P, Sander M, Shehata N, Thorpe KE, Mazer CD. Prolonged mechanical ventilation after cardiac surgery: substudy of the Transfusion Requirements in Cardiac Surgery III trial. Can J Anaesth. 2022 Dec;69(12):1493-1506. doi: 10.1007/s12630-022-02319-9. Epub 2022 Sep 19.

  PMID: 36123418 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

• Mazer CD, Whitlock RP, Fergusson DA, Belley-Cote E, Connolly K, Khanykin B, Gregory AJ, de Medicis E, Carrier FM, McGuinness S, Young PJ, Byrne K, Villar JC, Royse A, Grocott HP, Seeberger MD, Mehta C, Lellouche F, Hare GMT, Painter TW, Fremes S, Syed S, Bagshaw SM, Hwang NC, Royse C, Hall J, Dai D, Mistry N, Thorpe K, Verma S, Juni P, Shehata N; TRICS Investigators and Perioperative Anesthesia Clinical Trials Group. Six-Month Outcomes after Restrictive or Liberal Transfusion for Cardiac Surgery. N Engl J Med. 2018 Sep 27;379(13):1224-1233. doi: 10.1056/NEJMoa1808561. Epub 2018 Aug 26.

  PMID: 30146969 DERIVED

• Garg AX, Shehata N, McGuinness S, Whitlock R, Fergusson D, Wald R, Parikh C, Bagshaw SM, Khanykin B, Gregory A, Syed S, Hare GMT, Cuerden MS, Thorpe KE, Hall J, Verma S, Roshanov PS, Sontrop JM, Mazer CD. Risk of Acute Kidney Injury in Patients Randomized to a Restrictive Versus Liberal Approach to Red Blood Cell Transfusion in Cardiac Surgery: A Substudy Protocol of the Transfusion Requirements in Cardiac Surgery III Noninferiority Trial. Can J Kidney Health Dis. 2018 Jan 3;5:2054358117749532. doi: 10.1177/2054358117749532. eCollection 2018.

  PMID: 29326843 DERIVED

• Shehata N, Whitlock R, Fergusson DA, Thorpe KE, MacAdams C, Grocott HP, Rubens F, Fremes S, Lellouche F, Bagshaw S, Royse A, Rosseel PM, Hare G, Medicis E, Hudson C, Belley-Cote E, Bainbridge D, Kent B, Shaw A, Byrne K, Syed S, Royse CF, McGuiness S, Hall J, Mazer CD. Transfusion Requirements in Cardiac Surgery III (TRICS III): Study Design of a Randomized Controlled Trial. J Cardiothorac Vasc Anesth. 2018 Feb;32(1):121-129. doi: 10.1053/j.jvca.2017.10.036. Epub 2017 Nov 3.

  PMID: 29273477 DERIVED

• Mazer CD, Whitlock RP, Fergusson DA, Hall J, Belley-Cote E, Connolly K, Khanykin B, Gregory AJ, de Medicis E, McGuinness S, Royse A, Carrier FM, Young PJ, Villar JC, Grocott HP, Seeberger MD, Fremes S, Lellouche F, Syed S, Byrne K, Bagshaw SM, Hwang NC, Mehta C, Painter TW, Royse C, Verma S, Hare GMT, Cohen A, Thorpe KE, Juni P, Shehata N; TRICS Investigators and Perioperative Anesthesia Clinical Trials Group. Restrictive or Liberal Red-Cell Transfusion for Cardiac Surgery. N Engl J Med. 2017 Nov 30;377(22):2133-2144. doi: 10.1056/NEJMoa1711818. Epub 2017 Nov 12.

  PMID: 29130845 DERIVED

Study Officials

• David Mazer, MD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

• Nadine Shehata, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

• Richard Whitlock, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

• Dean Fergusson, MD

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

• Kevin Thorpe, MSc

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2014
• First Posted: January 23, 2014
• Study Start: January 20, 2014
• Primary Completion: April 28, 2017
• Study Completion: October 1, 2017
• Last Updated: August 15, 2018

Record last verified: 2018-08

Locations

DK (1); EG (1); DE (2); CO (5); ES (4); US (8); GR (1); RO (1); CH (2); IL (2); MY (1); SG (1); BR (1); CA (22); AU (12); CN (2); NZ (5); ZA (1); IN (2)