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Transfusion Requirements in Younger Patients Undergoing Cardiac Surgery (TRICS-IV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04754022
Recruitment Status : Recruiting
First Posted : February 15, 2021
Last Update Posted : February 25, 2022
Sponsor:
Information provided by (Responsible Party):
Unity Health Toronto

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.

Condition or disease Intervention/treatment Phase
Disorder Heart Postoperative Cardiac Surgery Other: Restrictive Transfusion Strategy Other: Liberal transfusion strategy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An International, Multi-centre, Randomized Controlled Trial to Assess Transfusion Thresholds in Younger Patients Undergoing Cardiac Surgery
Actual Study Start Date : November 1, 2021
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Other: 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: 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.




Primary Outcome Measures :
  1. 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). [ Time Frame: Within 6 months after cardiac surgery. ]
    Any of all-cause mortality, myocardial infarction, new onset renal failure requiring dialysis, or new focal neurological deficit (stroke).


Secondary Outcome Measures :
  1. 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). [ Time Frame: Within 6 months after cardiac surgery. ]
    Incidence of all-cause mortality, myocardial infarction, new onset renal failure requiring dialysis, and new focal neurological deficit (stroke).

  2. Composite and individual all-cause mortality, myocardial infarction, new onset renal failure requiring dialysis, and new focal neurological deficit (stroke). [ Time Frame: Up to hospital discharge or after 28 days postoperatively, whichever comes first. ]
    Composite and individual incidence of all-cause mortality, myocardial infarction, new onset renal failure requiring dialysis, and new focal neurological deficit (stroke).

  3. Length of stay in the ICU and hospital. [ Time Frame: Up to hospital discharge or after 28 days postoperatively, whichever comes first. ]
    Length of stay in the ICU and hospital in days.

  4. Prolonged low output state. [ Time Frame: Up to hospital discharge or after 28 days postoperatively, whichever comes first. ]
    Defined as the need for two or more inotropes for 24 hours or more, intra-aortic balloon pump or ventricular assist device postoperatively.

  5. Duration of mechanical ventilation. [ Time Frame: Up to hospital discharge or after 28 days postoperatively, whichever comes first. ]
    Time on mechanical ventilation.

  6. Incidence of infection. [ Time Frame: Up to hospital discharge or after 28 days postoperatively, whichever comes first. ]
    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.

  7. Acute kidney injury. [ Time Frame: Up to hospital discharge or after 28 days postoperatively, whichever comes first. ]
    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.

  8. Delirium. [ Time Frame: Up to hospital discharge or after 28 days postoperatively, whichever comes first. ]
    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.

  9. Incidence of gut infarction. [ Time Frame: Up to hospital discharge or after 28 days postoperatively, whichever comes first. ]
    Confirmed by imaging (e.g. angiography), autopsy, or through surgical means.

  10. Hospital visits. [ Time Frame: Within 6 months after cardiac surgery. ]
    Hospitalization and/or emergency visits and coronary revascularization after index procedure.

  11. Transfusion requirements. [ Time Frame: Up to hospital discharge or after 28 days postoperatively, whichever comes first. ]
    The proportion of patients transfused and the number of blood products utilized (RBCs, plasma, platelets).

  12. Incidence of seizures. [ Time Frame: Up to hospital discharge or after 28 days postoperatively, whichever comes first. ]
    Generalized or focal tonic-clonic movements consistent with seizure; or electroencephalogram demonstrating epileptiform discharges; or diagnosis of seizures by neurologist or neurosurgeon consultation.

  13. Incidence of encephalopathy. [ Time Frame: Up to hospital discharge or after 28 days postoperatively, whichever comes first. ]
    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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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04754022


Locations
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Canada, British Columbia
Interior Health Kelowna General Hospital Recruiting
Kelowna, British Columbia, Canada, V1Y 0C5
Contact: Nick Kuzak    250-808-3035    nick.kuzak@interiorhealth.ca   
Principal Investigator: Nick Kuzak         
Canada, New Brunswick
Saint John Regional Hospitall Recruiting
Saint John, New Brunswick, Canada, E2L 4L2
Contact: Craig Brown    506-648-6102    cdbrown@nbnet.nb.ca   
Principal Investigator: Craig Brown         
Canada, Ontario
Hamilton Health Sciences Centre / Hamilton General Hospital Recruiting
Hamilton, Ontario, Canada, L8L 2X2
Contact: Richard Whitlock    905-521-2100 ext 40306    Richard.whitlock@phri.ca   
Principal Investigator: Richard Whitlock         
St. Michael's Hospital, Unity Health Toronto Recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: David Mazer, MD    416-864-5825    david.mazer@unityhealth.to   
Principal Investigator: David Mazer, MD         
Canada, Quebec
Centre hospitalier de l'Université de Montréal Recruiting
Montréal, Quebec, Canada, H2X 0C1
Contact: François Carrier    514-890-8444    francois.martin.carrier@umontreal.ca   
Principal Investigator: François Carrier         
Institut universitaire de cardiologie et de pneumology de Québec - université Laval (IUCPQ-UL) Recruiting
Québec, Quebec, Canada, G1V 4G5
Contact: Étienne J Couture    418-656-8711 ext 2641    etienne.couture.3@ulaval.ca   
Principal Investigator: Étienne J Couture         
Russian Federation
Saint-Petersburg State University Hospital Recruiting
Saint Petersburg, Russian Federation
Contact: Sergey Efremov    7 913 794 6090    sergefremov@mail.ru   
Principal Investigator: Sergey Efremov         
Sponsors and Collaborators
Unity Health Toronto
Investigators
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Principal Investigator: David Mazer, MD Unity Health Toronto
Principal Investigator: Nadine Shehata, MD MOUNT SINAI HOSPITAL
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Unity Health Toronto
ClinicalTrials.gov Identifier: NCT04754022    
Other Study ID Numbers: TRICS-IV
First Posted: February 15, 2021    Key Record Dates
Last Update Posted: February 25, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Unity Health Toronto:
Cardiac Surgery
Transfusion