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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
Titles & IDs
Public title
Transfusion Requirements in Cardiac Surgery III
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Scientific title
An International, Multi-centre, Randomized Controlled Trial to Assess Transfusion Thresholds in Patients Undergoing Cardiac Surgery
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Secondary ID [1]
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301852
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Secondary ID [2]
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TRICSIII
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Universal Trial Number (UTN)
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Trial acronym
TRICS-III
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Disorder; Heart, Functional, Postoperative, Cardiac Surgery
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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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.
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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
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Assessment method [1]
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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
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Timepoint [1]
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Up to hospital discharge or postoperative day 28 (whichever occurs first)
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Secondary outcome [1]
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Incidence of in-hospital all-cause mortality
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Assessment method [1]
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Timepoint [1]
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Up to hospital discharge or postoperative day 28 (whichever occurs first)
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Secondary outcome [2]
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Incidence of in-hospital myocardial infarction
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Assessment method [2]
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Timepoint [2]
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Up to hospital discharge or postoperative day 28 (whichever occurs first)
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Secondary outcome [3]
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Incidence of in-hospital new renal failure requiring dialysis
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Assessment method [3]
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Timepoint [3]
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Up to hospital discharge or postoperative day 28 (whichever occurs first)
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Secondary outcome [4]
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Incidence of in-hospital new focal neurological deficit
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Assessment method [4]
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Timepoint [4]
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Up to hospital discharge or postoperative day 28 (whichever occurs first)
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Secondary outcome [5]
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Length of stay in the ICU and hospital
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Assessment method [5]
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Timepoint [5]
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Up to hospital discharge or postoperative day 28 (whichever occurs first)
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Secondary outcome [6]
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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
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Assessment method [6]
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Timepoint [6]
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Up to hospital discharge or postoperative day 28 (whichever occurs first)
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Secondary outcome [7]
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Duration of mechanical ventilation
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Assessment method [7]
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Timepoint [7]
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Up to hospital discharge or postoperative day 28 (whichever occurs first)
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Secondary outcome [8]
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Incidence of infection
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Assessment method [8]
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Timepoint [8]
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Up to hospital discharge or postoperative day 28 (whichever occurs first)
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Secondary outcome [9]
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Acute kidney injury (defined by Kidney Disease Improving Global Outcomes criteria)
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Assessment method [9]
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Timepoint [9]
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Up to hospital discharge or postoperative day 28 (whichever occurs first)
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Secondary outcome [10]
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Incidence of gut infarction
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Assessment method [10]
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Timepoint [10]
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Up to hospital discharge or postoperative day 28 (whichever occurs first)
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Secondary outcome [11]
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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)
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Assessment method [11]
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Timepoint [11]
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Up to hospital discharge or postoperative day 28 (whichever occurs first)
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Secondary outcome [12]
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Death
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Assessment method [12]
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Timepoint [12]
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6 months
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Secondary outcome [13]
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New onset dialysis (since incident surgery) status
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Assessment method [13]
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Timepoint [13]
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6 months
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Secondary outcome [14]
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Stroke
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Assessment method [14]
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Timepoint [14]
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6 months
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Secondary outcome [15]
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Coronary revascularization
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Assessment method [15]
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Timepoint [15]
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6 months
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Secondary outcome [16]
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Myocardial infarction
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Assessment method [16]
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Timepoint [16]
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6 months
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Secondary outcome [17]
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Health Care Utilization
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Assessment method [17]
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Timepoint [17]
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6 months
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Secondary outcome [18]
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Renal function, based on changes in postoperative serum creatinine
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Assessment method [18]
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Timepoint [18]
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Up to hospital discharge or postoperative day 28 (whichever occurs first)
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Secondary outcome [19]
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Incidence of Seizures
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Assessment method [19]
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Timepoint [19]
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Up to hospital discharge or postoperative day 28 (whichever occurs first)
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Secondary outcome [20]
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Incidence of Encephalopathy
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Assessment method [20]
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Timepoint [20]
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Up to hospital discharge or postoperative day 28 (whichever occurs first)
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Secondary outcome [21]
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Incidence of Delirium
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Assessment method [21]
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Timepoint [21]
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Up to hospital discharge or postoperative day 28 (whichever occurs first)
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Other
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
20/01/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/10/2017
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Sample size
Target
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Accrual to date
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Final
5028
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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Recruitment hospital [1]
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [2]
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Royal North Shore Hospital - Sydney
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Westmead Hospital - Westmead
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Royal Adelaide Hospital - Adelaide
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Flinders Medical Centre - Bedford Park
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Monash Medical Centre - Clayton
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St Vincent's Hospital, Melbourne - Fitzroy
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Recruitment hospital [8]
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Austin Hospital - Heidelberg
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Cabrini Health - Malvern
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Alfred Hospital - Melbourne
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Barwon Health (University Hospital Geelong) - Melbourne
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Recruitment hospital [12]
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Royal Melbourne Hospital - Parkville
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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2065 - Sydney
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Recruitment postcode(s) [3]
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2145 - Westmead
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Recruitment postcode(s) [4]
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5000 - Adelaide
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Recruitment postcode(s) [5]
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5042 - Bedford Park
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Recruitment postcode(s) [6]
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3168 - Clayton
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Recruitment postcode(s) [7]
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3065 - Fitzroy
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Recruitment postcode(s) [8]
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3084 - Heidelberg
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Recruitment postcode(s) [9]
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3144 - Malvern
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Recruitment postcode(s) [10]
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3004 - Melbourne
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Recruitment postcode(s) [11]
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3220 - Melbourne
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Recruitment postcode(s) [12]
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3050 - Parkville
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Recruitment outside Australia
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United States of America
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California
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United States of America
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Connecticut
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United States of America
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Maine
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Texas
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Brazil
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Rio de Janeiro
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Alberta
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Canada
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British Columbia
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Canada
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Manitoba
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New Brunswick
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Canada
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Newfoundland and Labrador
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Nova Scotia
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Ontario
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Shanghai
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Copenhagen
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Egypt
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Tanta
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Germany
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Berlin
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Germany
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Giessen
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Karnataka
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Gujarat
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Israel
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Ramat Gan
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Israel
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Tel Aviv
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Malaysia
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Kuala Lampur
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Auckland
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Christchurch
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Dunedin
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New Zealand
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Hamilton
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New Zealand
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Wellington
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Romania
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Târgu-Mure?
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Singapore
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KwaZulu-Natal
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Barcelona
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Spain
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Madrid
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Spain
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Valencia
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Switzerland
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Basel
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Switzerland
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Bern
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Funding & Sponsors
Primary sponsor type
Other
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Name
Unity Health Toronto
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Address
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT02042898
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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.
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Public notes
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Contacts
Principal investigator
Name
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David Mazer, MD
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Address
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Unity Health Toronto
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02042898