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

• ClinicalTrials.gov Identifier: NCT04754022
• Recruitment Status: Recruiting
• First Posted: February 15, 2021
• Last Update Posted: February 25, 2022
• Sponsor: Unity Health Toronto
• Information provided by (Responsible Party): Unity Health Toronto

Study Description

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

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

• 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)

Contacts and Locations

Locations

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

• Principal Investigator: David Mazer, MD; Unity Health Toronto
• Principal Investigator: Nadine Shehata, MD; MOUNT SINAI HOSPITAL

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Dorée C, Hébert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12:CD002042. doi: 10.1002/14651858.CD002042.pub5. Review.

• Responsible Party: Unity Health Toronto
• ClinicalTrials.gov Identifier: NCT04754022
• Other Study ID Numbers: TRICS-IV
• First Posted: February 15, 2021
• Last Update Posted: February 25, 2022
• Last Verified: February 2022

• 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