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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04754022
Registration number
NCT04754022
Ethics application status
Date submitted
9/02/2021
Date registered
15/02/2021
Date last updated
25/02/2022
Titles & IDs
Public title
Transfusion Requirements in Younger Patients Undergoing Cardiac Surgery
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Scientific title
An International, Multi-centre, Randomized Controlled Trial to Assess Transfusion Thresholds in Younger Patients Undergoing Cardiac Surgery
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Secondary ID [1]
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TRICS-IV
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Universal Trial Number (UTN)
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Trial acronym
TRICS-IV
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Disorder
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Heart
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Postoperative
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Cardiac Surgery
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Restrictive Transfusion Strategy
Other interventions - Liberal transfusion strategy
Active Comparator: Restrictive Transfusion Strategy - Patients will receive a RBC transfusion if their Hb concentration is <75 g/L (<7.5 g/dL; <4.7mmol/L) intraoperatively and/or postoperatively.
Active Comparator: Liberal Transfusion Strategy - Patients will receive a RBC transfusion if their Hb concentration is <95 g/L (<9.5 g/dL; <5.9mmol/L) intraoperatively, or postoperatively in the ICU; and/or <85 g/L (< 8.5 g/dL; <5.3mmol/L) on the ward.
Other interventions: Restrictive Transfusion Strategy
Patients will receive a RBC transfusion if their Hb concentration is <75 g/L (<7.5 g/dL; <4.7mmol/L) intraoperatively and/or postoperatively.
Other interventions: Liberal transfusion strategy
Patients will receive a RBC transfusion if their Hb concentration is <95 g/L (<9.5 g/dL; <5.9mmol/L) intraoperatively, or postoperatively in the ICU; and/or <85 g/L (< 8.5 g/dL; <5.3mmol/L) on the ward.
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Intervention code [1]
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Other interventions
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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 events occurring 6 months after cardiac surgery: (1) all-cause mortality; (2) myocardial infarction; (3) new onset renal failure requiring dialysis; or (4) new focal neurological deficit (stroke).
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Assessment method [1]
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Any of all-cause mortality, myocardial infarction, new onset renal failure requiring dialysis, or new focal neurological deficit (stroke).
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Timepoint [1]
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Within 6 months after cardiac surgery.
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Secondary outcome [1]
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Incidence of each individual component of the primary outcome: all-cause mortality, myocardial infarction, new onset renal failure requiring dialysis, and new focal neurological deficit (stroke).
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Assessment method [1]
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Incidence of all-cause mortality, myocardial infarction, new onset renal failure requiring dialysis, and new focal neurological deficit (stroke).
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Timepoint [1]
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Within 6 months after cardiac surgery.
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Secondary outcome [2]
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Composite and individual all-cause mortality, myocardial infarction, new onset renal failure requiring dialysis, and new focal neurological deficit (stroke).
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Assessment method [2]
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Composite and individual incidence of all-cause mortality, myocardial infarction, new onset renal failure requiring dialysis, and new focal neurological deficit (stroke).
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Timepoint [2]
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Up to hospital discharge or after 28 days postoperatively, whichever comes first.
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Secondary outcome [3]
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Length of stay in the ICU and hospital.
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Assessment method [3]
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Length of stay in the ICU and hospital in days.
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Timepoint [3]
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Up to hospital discharge or after 28 days postoperatively, whichever comes first.
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Secondary outcome [4]
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Prolonged low output state.
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Assessment method [4]
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Defined as the need for two or more inotropes for 24 hours or more, intra-aortic balloon pump or ventricular assist device postoperatively.
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Timepoint [4]
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Up to hospital discharge or after 28 days postoperatively, whichever comes first.
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Secondary outcome [5]
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Duration of mechanical ventilation.
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Assessment method [5]
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Time on mechanical ventilation.
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Timepoint [5]
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Up to hospital discharge or after 28 days postoperatively, whichever comes first.
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Secondary outcome [6]
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Incidence of infection.
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Assessment method [6]
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Defined as septic shock with positive blood cultures; pneumonia defined as autopsy diagnosis or roentgenographic infiltrate and at least two out of three of the following criteria: fever, leukocytosis, and positive sputum culture; and/or deep sternal or leg wound infection requiring intravenous antibiotics and/or surgical debridement.
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Timepoint [6]
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Up to hospital discharge or after 28 days postoperatively, whichever comes first.
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Secondary outcome [7]
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Acute kidney injury.
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Assessment method [7]
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Defined by the Kidney Disease Improving Global Outcomes (KDIGO) clinical practice guideline - a 50% increase in serum creatinine within 1 week or a 26.5 mmol/L increase within 48 hours.
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Timepoint [7]
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Up to hospital discharge or after 28 days postoperatively, whichever comes first.
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Secondary outcome [8]
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Delirium.
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Assessment method [8]
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Confusion Assessment Method (CAM) or CAM-ICU (even on 1 occasion), or Intensive Care Delirium Screening Checklist (ICDSC) > 3, or 3D-CAM, or 4AT =4, or more than one dose of haloperidol or similar antipsychotic drug, or documented delirium by neurologist or neurosurgeon or psychiatrist consultation.
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Timepoint [8]
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Up to hospital discharge or after 28 days postoperatively, whichever comes first.
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Secondary outcome [9]
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Incidence of gut infarction.
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Assessment method [9]
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Confirmed by imaging (e.g. angiography), autopsy, or through surgical means.
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Timepoint [9]
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Up to hospital discharge or after 28 days postoperatively, whichever comes first.
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Secondary outcome [10]
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Hospital visits.
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Assessment method [10]
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Hospitalization and/or emergency visits and coronary revascularization after index procedure.
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Timepoint [10]
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Within 6 months after cardiac surgery.
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Secondary outcome [11]
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Transfusion requirements.
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Assessment method [11]
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The proportion of patients transfused and the number of blood products utilized (RBCs, plasma, platelets).
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Timepoint [11]
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Up to hospital discharge or after 28 days postoperatively, whichever comes first.
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Secondary outcome [12]
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Incidence of seizures.
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Assessment method [12]
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Generalized or focal tonic-clonic movements consistent with seizure; or electroencephalogram demonstrating epileptiform discharges; or diagnosis of seizures by neurologist or neurosurgeon consultation.
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Timepoint [12]
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Up to hospital discharge or after 28 days postoperatively, whichever comes first.
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Secondary outcome [13]
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Incidence of encephalopathy.
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Assessment method [13]
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Unexpected delayed awakening or severely altered mental status (unconscious despite no sedative medication for more than 5 days), or encephalopathy documented by neurologist or neurosurgeon or psychiatrist consultation.
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Timepoint [13]
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Up to hospital discharge or after 28 days postoperatively, whichever comes first.
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Eligibility
Key inclusion criteria
1. =18 and =65 years of age
2. Planned cardiac surgery using cardiopulmonary bypass
3. Informed consent obtained
4. 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
65
Years
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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
1. Patients who refuse participation
2. Patients who are unable to receive or who refuse blood products
3. Patients who are involved in a preoperative autologous pre-donation program
4. Patients who are having a heart transplant or having surgery solely for an insertion
of a ventricular assist device
5. Pregnancy or lactation (a negative pregnancy test must be obtained prior to
randomization for women of childbearing potential)
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Study design
Purpose of the study
Treatment
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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
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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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
1/11/2021
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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
1/01/2024
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Actual
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Sample size
Target
1440
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
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Canada
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State/province [1]
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British Columbia
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Canada
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State/province [2]
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New Brunswick
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Canada
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Ontario
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Country [4]
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Canada
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State/province [4]
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Quebec
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Country [5]
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Russian Federation
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State/province [5]
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Saint Petersburg
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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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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
TRICS-IV is an international, multi-centre, open-label randomized controlled trial of two
commonly used transfusion strategies in moderate to high risk patients who are 65 years of
age or younger undergoing cardiac surgery on cardiopulmonary bypass, using a superiority
trial design.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04754022
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
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David Mazer, MD
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Address
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Unity Health Toronto
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04754022
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