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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02042898




Registration number
NCT02042898
Ethics application status
Date submitted
17/01/2014
Date registered
23/01/2014
Date last updated
15/08/2018

Titles & IDs
Public title
Transfusion Requirements in Cardiac Surgery III
Scientific title
An International, Multi-centre, Randomized Controlled Trial to Assess Transfusion Thresholds in Patients Undergoing Cardiac Surgery
Secondary ID [1] 0 0
301852
Secondary ID [2] 0 0
TRICSIII
Universal Trial Number (UTN)
Trial acronym
TRICS-III
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Disorder; Heart, Functional, Postoperative, Cardiac Surgery 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Active comparator: 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

Active comparator: 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.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Up to hospital discharge or postoperative day 28 (whichever occurs first)
Secondary outcome [1] 0 0
Incidence of in-hospital all-cause mortality
Timepoint [1] 0 0
Up to hospital discharge or postoperative day 28 (whichever occurs first)
Secondary outcome [2] 0 0
Incidence of in-hospital myocardial infarction
Timepoint [2] 0 0
Up to hospital discharge or postoperative day 28 (whichever occurs first)
Secondary outcome [3] 0 0
Incidence of in-hospital new renal failure requiring dialysis
Timepoint [3] 0 0
Up to hospital discharge or postoperative day 28 (whichever occurs first)
Secondary outcome [4] 0 0
Incidence of in-hospital new focal neurological deficit
Timepoint [4] 0 0
Up to hospital discharge or postoperative day 28 (whichever occurs first)
Secondary outcome [5] 0 0
Length of stay in the ICU and hospital
Timepoint [5] 0 0
Up to hospital discharge or postoperative day 28 (whichever occurs first)
Secondary outcome [6] 0 0
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
Timepoint [6] 0 0
Up to hospital discharge or postoperative day 28 (whichever occurs first)
Secondary outcome [7] 0 0
Duration of mechanical ventilation
Timepoint [7] 0 0
Up to hospital discharge or postoperative day 28 (whichever occurs first)
Secondary outcome [8] 0 0
Incidence of infection
Timepoint [8] 0 0
Up to hospital discharge or postoperative day 28 (whichever occurs first)
Secondary outcome [9] 0 0
Acute kidney injury (defined by Kidney Disease Improving Global Outcomes criteria)
Timepoint [9] 0 0
Up to hospital discharge or postoperative day 28 (whichever occurs first)
Secondary outcome [10] 0 0
Incidence of gut infarction
Timepoint [10] 0 0
Up to hospital discharge or postoperative day 28 (whichever occurs first)
Secondary outcome [11] 0 0
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)
Timepoint [11] 0 0
Up to hospital discharge or postoperative day 28 (whichever occurs first)
Secondary outcome [12] 0 0
Death
Timepoint [12] 0 0
6 months
Secondary outcome [13] 0 0
New onset dialysis (since incident surgery) status
Timepoint [13] 0 0
6 months
Secondary outcome [14] 0 0
Stroke
Timepoint [14] 0 0
6 months
Secondary outcome [15] 0 0
Coronary revascularization
Timepoint [15] 0 0
6 months
Secondary outcome [16] 0 0
Myocardial infarction
Timepoint [16] 0 0
6 months
Secondary outcome [17] 0 0
Health Care Utilization
Timepoint [17] 0 0
6 months
Secondary outcome [18] 0 0
Renal function, based on changes in postoperative serum creatinine
Timepoint [18] 0 0
Up to hospital discharge or postoperative day 28 (whichever occurs first)
Secondary outcome [19] 0 0
Incidence of Seizures
Timepoint [19] 0 0
Up to hospital discharge or postoperative day 28 (whichever occurs first)
Secondary outcome [20] 0 0
Incidence of Encephalopathy
Timepoint [20] 0 0
Up to hospital discharge or postoperative day 28 (whichever occurs first)
Secondary outcome [21] 0 0
Incidence of Delirium
Timepoint [21] 0 0
Up to hospital discharge or postoperative day 28 (whichever occurs first)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/01/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2017
Sample size
Target
Accrual to date
Final
5028
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Royal North Shore Hospital - Sydney
Recruitment hospital [3] 0 0
Westmead Hospital - Westmead
Recruitment hospital [4] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [5] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [6] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [7] 0 0
St Vincent's Hospital, Melbourne - Fitzroy
Recruitment hospital [8] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [9] 0 0
Cabrini Health - Malvern
Recruitment hospital [10] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [11] 0 0
Barwon Health (University Hospital Geelong) - Melbourne
Recruitment hospital [12] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2065 - Sydney
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
5042 - Bedford Park
Recruitment postcode(s) [6] 0 0
3168 - Clayton
Recruitment postcode(s) [7] 0 0
3065 - Fitzroy
Recruitment postcode(s) [8] 0 0
3084 - Heidelberg
Recruitment postcode(s) [9] 0 0
3144 - Malvern
Recruitment postcode(s) [10] 0 0
3004 - Melbourne
Recruitment postcode(s) [11] 0 0
3220 - Melbourne
Recruitment postcode(s) [12] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Maine
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
Brazil
State/province [7] 0 0
Rio de Janeiro
Country [8] 0 0
Canada
State/province [8] 0 0
Alberta
Country [9] 0 0
Canada
State/province [9] 0 0
British Columbia
Country [10] 0 0
Canada
State/province [10] 0 0
Manitoba
Country [11] 0 0
Canada
State/province [11] 0 0
New Brunswick
Country [12] 0 0
Canada
State/province [12] 0 0
Newfoundland and Labrador
Country [13] 0 0
Canada
State/province [13] 0 0
Nova Scotia
Country [14] 0 0
Canada
State/province [14] 0 0
Ontario
Country [15] 0 0
Canada
State/province [15] 0 0
Quebec
Country [16] 0 0
China
State/province [16] 0 0
Shanghai
Country [17] 0 0
Colombia
State/province [17] 0 0
Santander
Country [18] 0 0
Colombia
State/province [18] 0 0
Bogota
Country [19] 0 0
Denmark
State/province [19] 0 0
Copenhagen
Country [20] 0 0
Egypt
State/province [20] 0 0
Tanta
Country [21] 0 0
Germany
State/province [21] 0 0
Berlin
Country [22] 0 0
Germany
State/province [22] 0 0
Giessen
Country [23] 0 0
Greece
State/province [23] 0 0
Volos
Country [24] 0 0
India
State/province [24] 0 0
Karnataka
Country [25] 0 0
India
State/province [25] 0 0
Gujarat
Country [26] 0 0
Israel
State/province [26] 0 0
Ramat Gan
Country [27] 0 0
Israel
State/province [27] 0 0
Tel Aviv
Country [28] 0 0
Malaysia
State/province [28] 0 0
Kuala Lampur
Country [29] 0 0
New Zealand
State/province [29] 0 0
Auckland
Country [30] 0 0
New Zealand
State/province [30] 0 0
Christchurch
Country [31] 0 0
New Zealand
State/province [31] 0 0
Dunedin
Country [32] 0 0
New Zealand
State/province [32] 0 0
Hamilton
Country [33] 0 0
New Zealand
State/province [33] 0 0
Wellington
Country [34] 0 0
Romania
State/province [34] 0 0
Târgu-Mure?
Country [35] 0 0
Singapore
State/province [35] 0 0
Singapore
Country [36] 0 0
South Africa
State/province [36] 0 0
KwaZulu-Natal
Country [37] 0 0
Spain
State/province [37] 0 0
Barcelona
Country [38] 0 0
Spain
State/province [38] 0 0
Madrid
Country [39] 0 0
Spain
State/province [39] 0 0
Valencia
Country [40] 0 0
Switzerland
State/province [40] 0 0
Basel
Country [41] 0 0
Switzerland
State/province [41] 0 0
Bern

Funding & Sponsors
Primary sponsor type
Other
Name
Unity Health Toronto
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT02042898
Trial related presentations / publications
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.
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.
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.
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.
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
David Mazer, MD
Address 0 0
Unity Health Toronto
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02042898