Clinical trial NCT02042898: Transfusion Requirements in Cardiac Surgery III
Official title: An International, Multi-centre, Randomized Controlled Trial to Assess Transfusion Thresholds in Patients Undergoing Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disorder; Heart, Functional, Postoperative, Cardiac Surgery
Keywords: Cardiac Surgery
Transfusion
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2014-01-23
Enrollment: 5028
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Up to hospital discharge or postoperative day 28 (whichever occurs first)
Secondary outcomes:
measure: Incidence of in-hospital all-cause mortality
timeFrame: Up to hospital discharge or postoperative day 28 (whichever occurs first)
measure: Incidence of in-hospital myocardial infarction
timeFrame: Up to hospital discharge or postoperative day 28 (whichever occurs first)
measure: Incidence of in-hospital new renal failure requiring dialysis
timeFrame: Up to hospital discharge or postoperative day 28 (whichever occurs first)
measure: Incidence of in-hospital new focal neurological deficit
timeFrame: Up to hospital discharge or postoperative day 28 (whichever occurs first)
measure: Length of stay in the ICU and hospital
timeFrame: Up to hospital discharge or postoperative day 28 (whichever occurs first)
measure: Prolonged low output state defined as the need for two or more inotropes for 24 hours or more, intra-aortic balloon pump postoperatively or ventricular assist device
timeFrame: Up to hospital discharge or postoperative day 28 (whichever occurs first)
measure: Duration of mechanical ventilation
timeFrame: Up to hospital discharge or postoperative day 28 (whichever occurs first)
measure: Incidence of infection
timeFrame: Up to hospital discharge or postoperative day 28 (whichever occurs first)
measure: Acute kidney injury (defined by Kidney Disease Improving Global Outcomes criteria)
timeFrame: Up to hospital discharge or postoperative day 28 (whichever occurs first)
measure: Incidence of gut infarction
timeFrame: Up to hospital discharge or postoperative day 28 (whichever occurs first)
measure: The proportion of patients transfused and the number of blood products and hemostatic products utilized (e.g. red cells, plasma, platelets, cryoprecipitate, factor VII) (index hospitalization)
timeFrame: Up to hospital discharge or postoperative day 28 (whichever occurs first)
measure: Death
timeFrame: 6 months
measure: New onset dialysis (since incident surgery) status
timeFrame: 6 months
measure: Stroke
timeFrame: 6 months
measure: Coronary revascularization
timeFrame: 6 months
measure: Myocardial infarction
timeFrame: 6 months
measure: Health Care Utilization
timeFrame: 6 months
measure: Renal function, based on changes in postoperative serum creatinine
timeFrame: Up to hospital discharge or postoperative day 28 (whichever occurs first)
measure: Incidence of Seizures
timeFrame: Up to hospital discharge or postoperative day 28 (whichever occurs first)
measure: Incidence of Encephalopathy
timeFrame: Up to hospital discharge or postoperative day 28 (whichever occurs first)
measure: Incidence of Delirium
timeFrame: Up to hospital discharge or postoperative day 28 (whichever occurs first)
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco VA Medical Center
state: California
city: New Haven
country: United States
facility: Yale-New Haven Hospital
state: Connecticut
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Durham
country: United States
facility: Durham Veterans Affairs Medical Center
state: North Carolina
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: Michael E. DeBakey Veterans Affairs Medical Center
state: Texas
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Fitzroy
country: Australia
facility: St Vincent's Hospital, Melbourne
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Hospital
state: Victoria
city: Malvern
country: Australia
facility: Cabrini Health
state: Victoria
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Barwon Health (University Hospital Geelong)
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Rio de Janeiro
country: Brazil
facility: Hospital Unimed Rio (National Institute of Cardiology)
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Kelowna
country: Canada
facility: Kelowna General Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Winnipeg
country: Canada
facility: St Boniface Hospital
state: Manitoba
city: Saint John
country: Canada
facility: Saint John Regional Hospital
state: New Brunswick
city: St John's
country: Canada
facility: Health Sciences Centre (Memorial University)
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: QEII Health Science Centre
state: Nova Scotia
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: London
country: Canada
facility: London Health Sciences Center
state: Ontario
city: Newmarket
country: Canada
facility: Southlake Regional Health Centre
state: Ontario
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: St Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: University Health Network Toronto General Hospital
state: Ontario
city: Chemin Sainte-Foy
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
state: Quebec
city: Montreal
country: Canada
facility: SMBD Jewish General Hospital
state: Quebec
city: Montreal
country: Canada
facility: Hôpital du Sacré-Cœur de Montréal
state: Quebec
city: Montreal
country: Canada
facility: Centre hospitalier de l'Université de Montréal
state: Quebec
city: Montréal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke
state: Quebec
city: Shanghai
country: China
facility: Shanghai Yodak Cardio-Thoracic Hospital
city: Shanghai
country: China
facility: Renji Hospital
city: Bucaramanga
country: Colombia
facility: Instituto del Corazón de Bucaramanga
state: Santander
city: Bogota
country: Colombia
facility: Clinica de Marly
city: Bogota
country: Colombia
facility: Fundacion Cardioinfantil Instituto de Cardiologia
city: Bogota
country: Colombia
facility: Fundación Clínica Shaio
city: Bogota
country: Colombia
facility: Hospital De San Jose
city: Copenhagen
country: Denmark
facility: Rigshospitalet - Copenhagen University Hospital
city: Tanta
country: Egypt
facility: Tanta University Hospital
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Giessen
country: Germany
facility: University Hospital Giessen
city: Volos
country: Greece
facility: University of Thessaly
city: Bangalore
country: India
facility: Narayana Health
state: Karnataka
city: Gujarat
country: India
facility: SAL Hospital
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Centre
city: Kuala Lampur
country: Malaysia
facility: Institut Jantung Negara
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
city: Dunedin
country: New Zealand
facility: Dunedin Hospital
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Wellington
country: New Zealand
facility: Wellington Hospital
city: Târgu-Mureș
country: Romania
facility: Emergency Institute for Cardiovascular Diseases
city: Singapore
country: Singapore
facility: National Heart Centre Singapore
city: Durban
country: South Africa
facility: University of KwaZulu-Natal
state: KwaZulu-Natal
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Valencia
country: Spain
facility: Consorcio Hospital General Universitario de Valencia
city: Valencia
country: Spain
facility: Instituto de Investigación Sanitaria Hospital Univ. & Politc. La Fe de Valencia
city: Basel
country: Switzerland
facility: University Hospital Basel
city: Bern
country: Switzerland
facility: University Hospital Bern (Inselspital)
Study officials:
affiliation: Unity Health Toronto
name: David Mazer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MOUNT SINAI HOSPITAL
name: Nadine Shehata, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Richard Whitlock, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ottawa Hospital Research Institute
name: Dean Fergusson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Toronto
name: Kevin Thorpe, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.