Disorder; Heart, Functional, Postoperative, Cardiac SurgeryTRICS-IIINCT02042898
Transfusion Requirements in Cardiac Surgery III
A study testing Restrictive Transfusion Strategy and Liberal transfusion strategy in people with Disorder; Heart, Functional, Postoperative, Cardiac Surgery, run by Unity Health Toronto at 74 sites in 19 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disorder; Heart, Functional, Postoperative, Cardiac Surgery
- 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
- 5,028 participants
- Where
- 74 sitesin 19 countries
- Study dates
- 20 Jan 2014to 1 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
74 sites in 19 countries.
74 sites in 19 countries
Canada22 sites
Foothills Medical Centre
Calgary, Alberta, T2N 2T9
Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
Chemin Sainte-Foy, Quebec, G1V 4G5
University of Alberta
Edmonton, Alberta, T6G 2R3
QEII Health Science Centre
Halifax, Nova Scotia, B3H 2Y9
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
Kelowna General Hospital
Kelowna, British Columbia, V1Y 1T2
Kingston General Hospital
Kingston, Ontario, K7L 2V7
London Health Sciences Center
London, Ontario, N6G 2V4
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
SMBD Jewish General Hospital
Montreal, Quebec, H3T 1E2
Hôpital du Sacré-Cœur de Montréal
Montreal, Quebec, H4J 1C5
Centre hospitalier de l'Université de Montréal
Montreal, Quebec
Southlake Regional Health Centre
Newmarket, Ontario, L3Y 2P9
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L4
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1G 2E8
Health Sciences Centre (Memorial University)
St. John's, Newfoundland and Labrador, A1B 3X9
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
St Michael's Hospital
Toronto, Ontario, M5B1W8
University Health Network Toronto General Hospital
Toronto, Ontario, M5G 2C4
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1L7
St Boniface Hospital
Winnipeg, Manitoba, R2H 2A6
Australia12 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Flinders Medical Centre
Bedford Park, South Australia, 5042
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Monash Medical Centre
Clayton, Victoria, 3168
St Vincent's Hospital, Melbourne
Fitzroy, Victoria, 3065
Austin Hospital
Heidelberg, Victoria, 3084
Cabrini Health
Malvern, Victoria, 3144
Alfred Hospital
Melbourne, Victoria, 3004
Barwon Health (University Hospital Geelong)
Melbourne, Victoria, 3220
Royal Melbourne Hospital
Parkville, Victoria, 3050
Royal North Shore Hospital
Sydney, New South Wales, 2065
Westmead Hospital
Westmead, New South Wales, 2145
United States8 sites
University of Texas Southwestern Medical Center
Dallas, Texas, 75235
Durham Veterans Affairs Medical Center
Durham, North Carolina, 27705
Baylor College of Medicine
Houston, Texas, 77030
Michael E. DeBakey Veterans Affairs Medical Center
Houston, Texas, 77030
Yale-New Haven Hospital
New Haven, Connecticut, 06510-3202
Maine Medical Center
Portland, Maine
San Francisco VA Medical Center
San Francisco, California, 94121
Montefiore Medical Center
The Bronx, New York, 10467
Colombia5 sites
Clinica de Marly
Bogotá
Fundacion Cardioinfantil Instituto de Cardiologia
Bogotá
Fundación Clínica Shaio
Bogotá
Hospital De San Jose
Bogotá
Instituto del Corazón de Bucaramanga
Bucaramanga, Santander Department
New Zealand5 sites
Auckland City Hospital
Auckland, 1023
Christchurch Hospital
Christchurch, 4710
Dunedin Hospital
Dunedin, 9016
Waikato Hospital
Hamilton, 3204
Wellington Hospital
Wellington, 6021
Spain4 sites
Hospital de la Santa Creu i Sant Pau
Barcelona
Hospital Ramón y Cajal
Madrid
Consorcio Hospital General Universitario de Valencia
Valencia, 46014
Instituto de Investigación Sanitaria Hospital Univ. & Politc. La Fe de Valencia
Valencia, 46026
China2 sites
Shanghai Yodak Cardio-Thoracic Hospital
Shanghai, 200235
Renji Hospital
Shanghai
Germany2 sites
Charité - Universitätsmedizin Berlin
Berlin, 10117
University Hospital Giessen
Giessen
Israel2 sites
Sheba Medical Center
Ramat Gan, 5262100
Tel Aviv Sourasky Medical Centre
Tel Aviv, 64239
Switzerland2 sites
University Hospital Basel
Basel, 4056
University Hospital Bern (Inselspital)
Bern
Brazil1 site
Hospital Unimed Rio (National Institute of Cardiology)
Rio de Janeiro
Denmark1 site
Rigshospitalet - Copenhagen University Hospital
Copenhagen, 2100
South Africa1 site
University of KwaZulu-Natal
Durban, KwaZulu-Natal, 4041
About this study
Official title: An International, Multi-centre, Randomized Controlled Trial to Assess Transfusion Thresholds in Patients Undergoing Cardiac Surgery
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.
- Being tested
- Restrictive Transfusion Strategy, Liberal transfusion strategy
- Keywords
- Cardiac Surgery, Transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restrictive Transfusion StrategyOther
Liberal transfusion strategyOther
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Liberal transfusion strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to hospital discharge or postoperative day 28 (whichever occurs first)
Secondary outcomes (21)
Incidence of in-hospital all-cause mortality
Measured: Up to hospital discharge or postoperative day 28 (whichever occurs first)
Incidence of in-hospital myocardial infarction
Measured: Up to hospital discharge or postoperative day 28 (whichever occurs first)
Incidence of in-hospital new renal failure requiring dialysis
Measured: Up to hospital discharge or postoperative day 28 (whichever occurs first)
Incidence of in-hospital new focal neurological deficit
Measured: Up to hospital discharge or postoperative day 28 (whichever occurs first)
Length of stay in the ICU and hospital
Measured: Up to hospital discharge or postoperative day 28 (whichever occurs first)
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
Measured: Up to hospital discharge or postoperative day 28 (whichever occurs first)
Duration of mechanical ventilation
Measured: Up to hospital discharge or postoperative day 28 (whichever occurs first)
Incidence of infection
Measured: Up to hospital discharge or postoperative day 28 (whichever occurs first)
Acute kidney injury (defined by Kidney Disease Improving Global Outcomes criteria)
Measured: Up to hospital discharge or postoperative day 28 (whichever occurs first)
Incidence of gut infarction
Measured: Up to hospital discharge or postoperative day 28 (whichever occurs first)
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)
Measured: Up to hospital discharge or postoperative day 28 (whichever occurs first)
Death
Measured: 6 months
New onset dialysis (since incident surgery) status
Measured: 6 months
Stroke
Measured: 6 months
Coronary revascularization
Measured: 6 months
Myocardial infarction
Measured: 6 months
Health Care Utilization
Measured: 6 months
Renal function, based on changes in postoperative serum creatinine
Measured: Up to hospital discharge or postoperative day 28 (whichever occurs first)
Incidence of Seizures
Measured: Up to hospital discharge or postoperative day 28 (whichever occurs first)
Incidence of Encephalopathy
Measured: Up to hospital discharge or postoperative day 28 (whichever occurs first)
Incidence of Delirium
Measured: Up to hospital discharge or postoperative day 28 (whichever occurs first)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study start20 Jan 2014
- Primary completion28 Apr 2017
- Study completion1 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Disorder; Heart, Functional, Postoperative, Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5,028 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Mazer, MD, Principal investigator, Unity Health TorontoNadine Shehata, MD, Principal investigator, MOUNT SINAI HOSPITALRichard Whitlock, MD, Principal investigator, McMaster UniversityDean Fergusson, MD, Principal investigator, Ottawa Hospital Research InstituteKevin Thorpe, MSc, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02042898
- Sponsor's protocol ID
- TRICSIII
- Other IDs
- 301852
- Acronym
- TRICS-III
- Status last verified
- Aug 2018
- First submitted
- 17 Jan 2014
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
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 41114449Mistry 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.
PubMed 37575193Sankar 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.
PubMed 36123418Carson 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 34932836Mazer 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.
PubMed 30146969Garg 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.
PubMed 29326843Shehata 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.
PubMed 29273477Mazer 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.
PubMed 29130845
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International, Multi-centre, Randomized Controlled Trial to Assess Transfusion Thresholds in Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02042898
- Acronym / sponsor ID
- TRICS-III / TRICSIII
- Keywords
- Cardiac Surgery, Transfusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,028 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 20 Jan 2014 (actual)
- Primary completion
- 28 Apr 2017 (actual)
- Study completion
- 1 Oct 2017 (actual)
- First posted
- 23 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Restrictive transfusion strategy | Active comparator | Other: Restrictive Transfusion StrategyRestrictive 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 |
| Liberal transfusion strategy | Active comparator | Other: Liberal transfusion strategyLiberal 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Restrictive Transfusion Strategy | Other | Restrictive transfusion strategy |
| Liberal transfusion strategy | Other | Liberal transfusion strategy |
Primary outcome
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
Time frame: Up to hospital discharge or postoperative day 28 (whichever occurs first)
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
21 secondary outcomes
Incidence of in-hospital all-cause mortality
Time frame: Up to hospital discharge or postoperative day 28 (whichever occurs first)
Incidence of in-hospital myocardial infarction
Time frame: Up to hospital discharge or postoperative day 28 (whichever occurs first)
Incidence of in-hospital new renal failure requiring dialysis
Time frame: Up to hospital discharge or postoperative day 28 (whichever occurs first)
Incidence of in-hospital new focal neurological deficit
Time frame: Up to hospital discharge or postoperative day 28 (whichever occurs first)
Length of stay in the ICU and hospital
Time frame: Up to hospital discharge or postoperative day 28 (whichever occurs first)
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
Time frame: Up to hospital discharge or postoperative day 28 (whichever occurs first)
Duration of mechanical ventilation
Time frame: Up to hospital discharge or postoperative day 28 (whichever occurs first)
Incidence of infection
Time frame: Up to hospital discharge or postoperative day 28 (whichever occurs first)
Acute kidney injury (defined by Kidney Disease Improving Global Outcomes criteria)
Time frame: Up to hospital discharge or postoperative day 28 (whichever occurs first)
Incidence of gut infarction
Time frame: Up to hospital discharge or postoperative day 28 (whichever occurs first)
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)
Time frame: Up to hospital discharge or postoperative day 28 (whichever occurs first)
Death
Time frame: 6 months
New onset dialysis (since incident surgery) status
Time frame: 6 months
Stroke
Time frame: 6 months
Coronary revascularization
Time frame: 6 months
Myocardial infarction
Time frame: 6 months
Health Care Utilization
Time frame: 6 months
Renal function, based on changes in postoperative serum creatinine
Time frame: Up to hospital discharge or postoperative day 28 (whichever occurs first)
Incidence of Seizures
Time frame: Up to hospital discharge or postoperative day 28 (whichever occurs first)
Incidence of Encephalopathy
Time frame: Up to hospital discharge or postoperative day 28 (whichever occurs first)
Incidence of Delirium
Time frame: Up to hospital discharge or postoperative day 28 (whichever occurs first)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2018.
- Derived from this study: PubMed 41114449Carson 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.
- Derived from this study: PubMed 37575193Mistry 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.
- Derived from this study: PubMed 36123418Sankar 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.
- Derived from this study: PubMed 34932836Carson 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.
- Derived from this study: PubMed 30146969Mazer 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.
- Derived from this study: PubMed 29326843Garg 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.
- Derived from this study: PubMed 29273477Shehata 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.
- Derived from this study: PubMed 29130845Mazer 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Mazer, MD principal investigator
Unity Health Toronto
Nadine Shehata, MD principal investigator
MOUNT SINAI HOSPITAL
Richard Whitlock, MD principal investigator
McMaster University
74 sites in 19 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restrictive Transfusion Strategy and Liberal transfusion strategy in people with Disorder; Heart, Functional, Postoperative, Cardiac Surgery, run by Unity Health Toronto at 74 sites in 19 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: finished, as of the sponsor's last update on 15 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 74 sites in Canada, Australia, United States, Colombia, New Zealand and 14 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Up to hospital discharge or postoperative day 28 (whichever occurs first)). 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 NCT02042898, which also lists 8 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 15 Aug 2018.