Transfusion Requirements in Cardiac Surgery III

NCT ID: NCT02042898

Last Updated: 2018-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5028 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-20

Study Completion Date

2017-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Disorder; Heart, Functional, Postoperative, Cardiac Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Restrictive transfusion strategy

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

Group Type ACTIVE_COMPARATOR

Restrictive Transfusion Strategy

Intervention Type OTHER

Liberal transfusion strategy

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.

Group Type ACTIVE_COMPARATOR

Liberal transfusion strategy

Intervention Type OTHER

Interventions

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Restrictive Transfusion Strategy

Intervention Type OTHER

Liberal transfusion strategy

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Unity Health Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Mazer, MD

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Nadine Shehata, MD

Role: PRINCIPAL_INVESTIGATOR

MOUNT SINAI HOSPITAL

Richard Whitlock, MD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Dean Fergusson, MD

Role: PRINCIPAL_INVESTIGATOR

Ottawa Hospital Research Institute

Kevin Thorpe, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Locations

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San Francisco VA Medical Center

San Francisco, California, United States

Site Status

Yale-New Haven Hospital

New Haven, Connecticut, United States

Site Status

Maine Medical Center

Portland, Maine, United States

Site Status

Montefiore Medical Center

The Bronx, New York, United States

Site Status

Durham Veterans Affairs Medical Center

Durham, North Carolina, United States

Site Status

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status

Baylor College of Medicine

Houston, Texas, United States

Site Status

Michael E. DeBakey Veterans Affairs Medical Center

Houston, Texas, United States

Site Status

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Site Status

Royal North Shore Hospital

Sydney, New South Wales, Australia

Site Status

Westmead Hospital

Westmead, New South Wales, Australia

Site Status

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Site Status

Flinders Medical Centre

Bedford Park, South Australia, Australia

Site Status

Monash Medical Centre

Clayton, Victoria, Australia

Site Status

St Vincent's Hospital, Melbourne

Fitzroy, Victoria, Australia

Site Status

Austin Hospital

Heidelberg, Victoria, Australia

Site Status

Cabrini Health

Malvern, Victoria, Australia

Site Status

Alfred Hospital

Melbourne, Victoria, Australia

Site Status

Barwon Health (University Hospital Geelong)

Melbourne, Victoria, Australia

Site Status

Royal Melbourne Hospital

Parkville, Victoria, Australia

Site Status

Hospital Unimed Rio (National Institute of Cardiology)

Rio de Janeiro, , Brazil

Site Status

Foothills Medical Centre

Calgary, Alberta, Canada

Site Status

University of Alberta

Edmonton, Alberta, Canada

Site Status

Kelowna General Hospital

Kelowna, British Columbia, Canada

Site Status

Vancouver General Hospital

Vancouver, British Columbia, Canada

Site Status

St Boniface Hospital

Winnipeg, Manitoba, Canada

Site Status

Saint John Regional Hospital

Saint John, New Brunswick, Canada

Site Status

Health Sciences Centre (Memorial University)

St. John's, Newfoundland and Labrador, Canada

Site Status

QEII Health Science Centre

Halifax, Nova Scotia, Canada

Site Status

Hamilton General Hospital

Hamilton, Ontario, Canada

Site Status

Kingston General Hospital

Kingston, Ontario, Canada

Site Status

London Health Sciences Center

London, Ontario, Canada

Site Status

Southlake Regional Health Centre

Newmarket, Ontario, Canada

Site Status

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Site Status

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status

St Michael's Hospital

Toronto, Ontario, Canada

Site Status

University Health Network Toronto General Hospital

Toronto, Ontario, Canada

Site Status

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

Chemin Sainte-Foy, Quebec, Canada

Site Status

Montreal Heart Institute

Montreal, Quebec, Canada

Site Status

SMBD Jewish General Hospital

Montreal, Quebec, Canada

Site Status

Hôpital du Sacré-Cœur de Montréal

Montreal, Quebec, Canada

Site Status

Centre hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Site Status

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Site Status

Shanghai Yodak Cardio-Thoracic Hospital

Shanghai, , China

Site Status

Renji Hospital

Shanghai, , China

Site Status

Instituto del Corazón de Bucaramanga

Bucaramanga, Santander Department, Colombia

Site Status

Clinica de Marly

Bogotá, , Colombia

Site Status

Fundacion Cardioinfantil Instituto de Cardiologia

Bogotá, , Colombia

Site Status

Fundación Clínica Shaio

Bogotá, , Colombia

Site Status

Hospital De San Jose

Bogotá, , Colombia

Site Status

Rigshospitalet - Copenhagen University Hospital

Copenhagen, , Denmark

Site Status

Tanta University Hospital

Tanta, , Egypt

Site Status

Charité - Universitätsmedizin Berlin

Berlin, , Germany

Site Status

University Hospital Giessen

Giessen, , Germany

Site Status

University of Thessaly

Volos, , Greece

Site Status

Narayana Health

Bangalore, Karnataka, India

Site Status

SAL Hospital

Gujarat, , India

Site Status

Sheba Medical Center

Ramat Gan, , Israel

Site Status

Tel Aviv Sourasky Medical Centre

Tel Aviv, , Israel

Site Status

Institut Jantung Negara

Kuala Lampur, , Malaysia

Site Status

Auckland City Hospital

Auckland, , New Zealand

Site Status

Christchurch Hospital

Christchurch, , New Zealand

Site Status

Dunedin Hospital

Dunedin, , New Zealand

Site Status

Waikato Hospital

Hamilton, , New Zealand

Site Status

Wellington Hospital

Wellington, , New Zealand

Site Status

Emergency Institute for Cardiovascular Diseases

Târgu Mureş, , Romania

Site Status

National Heart Centre Singapore

Singapore, , Singapore

Site Status

University of KwaZulu-Natal

Durban, KwaZulu-Natal, South Africa

Site Status

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Site Status

Hospital Ramón y Cajal

Madrid, , Spain

Site Status

Consorcio Hospital General Universitario de Valencia

Valencia, , Spain

Site Status

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

Valencia, , Spain

Site Status

University Hospital Basel

Basel, , Switzerland

Site Status

University Hospital Bern (Inselspital)

Bern, , Switzerland

Site Status

Countries

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United States Australia Brazil Canada China Colombia Denmark Egypt Germany Greece India Israel Malaysia New Zealand Romania Singapore South Africa Spain Switzerland

References

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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:CD002042. doi: 10.1002/14651858.CD002042.pub6.

Reference Type DERIVED
PMID: 41114449 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37575193 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36123418 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34932836 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30146969 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29326843 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29273477 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29130845 (View on PubMed)

Other Identifiers

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301852

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

TRICSIII

Identifier Type: -

Identifier Source: org_study_id

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