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

November 18, 2024 updated by: Unity Health Toronto

An International, Multi-centre, Randomized Controlled Trial to Assess Transfusion Thresholds in Younger Patients Undergoing Cardiac Surgery

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1440

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
      • Adelaide, Australia, 5000
        • Recruiting
        • Royal Adelaide Hospital
        • Contact:
        • Contact:
          • Kate Drummond, MD
      • Melbourne, Australia
        • Recruiting
        • Royal Melbourne Hospital
        • Contact:
          • Alistair Royse, MD
        • Contact:
      • Prahran, Australia, 3181
        • Recruiting
        • Alfred Hospital
        • Contact:
        • Contact:
          • Paul Myles, MD
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Recruiting
        • Royal Prince Alfred Hospital
        • Contact:
        • Contact:
          • Paul Bannon, MD
      • Randwick, New South Wales, Australia, 2024
        • Recruiting
        • Prince of Wales Hospital
        • Contact:
        • Contact:
          • Aine Duggan, MD
      • Westmead, New South Wales, Australia, 2145
        • Recruiting
        • Westmead Hospital
        • Contact:
        • Contact:
          • Stefan Dieleman, MD
    • Queensland
      • Southport, Queensland, Australia, 4215
        • Recruiting
        • Gold Coast University Hospital
        • Contact:
        • Contact:
          • Matthew Beech, MD
    • South Australia
      • Bedford Park, South Australia, Australia, 5042
        • Recruiting
        • Flinders Medical Centre
        • Contact:
        • Contact:
          • Robert Baker
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Recruiting
        • Monash Health
        • Contact:
        • Contact:
          • Julian Smith, MD
      • Fitzroy, Victoria, Australia, 3065
        • Recruiting
        • St Vincent's Hospital Melbourne
        • Contact:
        • Contact:
          • David Scott, MD
      • Heidelberg, Victoria, Australia, 3084
        • Recruiting
        • Austin Health
        • Contact:
        • Contact:
          • Raymond Hu, MD
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • Recruiting
        • University of Alberta Hospital
        • Contact:
        • Contact:
          • Wing Lam, MD
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 0C5
        • Recruiting
        • Interior Health Kelowna General Hospital
        • Contact:
        • Contact:
          • Nick Kuzak
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Recruiting
        • Vancouver General Hospital
        • Contact:
        • Contact:
          • Darren Mullane, MD
    • New Brunswick
      • Saint John, New Brunswick, Canada, E2L 4L2
        • Recruiting
        • Saint John Regional Hospitall
        • Contact:
          • Craig Brown
        • Contact:
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Recruiting
        • Hamilton Health Sciences Centre / Hamilton General Hospital
        • Contact:
        • Contact:
          • Richard Whitlock
      • Kingston, Ontario, Canada, K7L 2V7
        • Active, not recruiting
        • Kingston Health Sciences Centre
      • Sudbury, Ontario, Canada, P3E 5J1
        • Recruiting
        • Health Sciences North Research Institute
        • Contact:
        • Contact:
          • Eugene Leshchyshyn, MD
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Sunnybrook Health Sciences Center
        • Contact:
          • Stephen Fremes, MD
        • Contact:
      • Toronto, Ontario, Canada, M5G 2C4
        • Recruiting
        • Toronto General Hospital
        • Contact:
        • Contact:
          • Matteo Parotto, MD
      • Toronto, Ontario, Canada, M5B 1W8
        • Recruiting
        • St. Michael's Hospital, Unity Health Toronto
        • Contact:
        • Contact:
          • David Mazer, MD
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Recruiting
        • Jewish General Hospital
        • Contact:
        • Contact:
          • Matthew Cameron, MD
      • Montreal, Quebec, Canada, H1T 1C8
        • Recruiting
        • Montreal Heart Institute
        • Contact:
        • Contact:
          • Antoine Rochon, MD
      • Montréal, Quebec, Canada, H2X 0C1
        • Recruiting
        • Centre Hospitalier de l'Université de Montréal
        • Contact:
        • Contact:
          • François Carrier
      • Montréal, Quebec, Canada, H4J 1C5
        • Recruiting
        • Hopital Sacre-Coeur de Montreal
        • Contact:
          • Hugues Jeanmart, MD
        • Contact:
      • Québec, Quebec, Canada, G1V 4G5
        • Recruiting
        • Institut universitaire de cardiologie et de pneumology de Québec - université Laval (IUCPQ-UL)
        • Contact:
        • Contact:
          • Étienne J Couture
  • Colombia
      • Bogota, Colombia, 110231
        • Recruiting
        • Hospital Universitario San Ignacio
        • Contact:
        • Contact:
          • Edgar Rios, MD
      • Bogota, Colombia
        • Recruiting
        • Fundacion Cardioinfantil
        • Contact:
        • Contact:
          • Edgar Leiva, MD
      • Bogota, Colombia, 111111
        • Recruiting
        • Fundación Abood Shaio
        • Contact:
        • Contact:
          • Mauricio Abello Sanchez, MD
  • Egypt
    • Cairo
      • Naşr, Cairo, Egypt, 4450010
        • Active, not recruiting
        • Nasr City Health Insurance Hospital
  • Greece
    • Evros
      • Alexandroupolis, Evros, Greece, 68100
        • Recruiting
        • Democritus University of Thrace
        • Contact:
        • Contact:
          • Dimos Karangelis, MD
  • India
    • Gujrat
      • Ahmedabad, Gujrat, India, 380060
        • Recruiting
        • Epic Hospital
        • Contact:
        • Contact:
          • Chirag Mehta, MD
  • Namibia
    • Khomas
      • Windhoek, Khomas, Namibia, 0000
        • Active, not recruiting
        • Windhoek Central Hospital
  • Nepal
      • Kathmandu, Nepal, 44600
        • Recruiting
        • Shahid Gangalal National Heart Center
        • Contact:
        • Contact:
          • Ashish Amatya, MD
  • Romania
      • Bucharest, Romania, 022322
        • Recruiting
        • Emergency Institute of Cardiovascular Diseases
        • Contact:
        • Contact:
          • Daniela Filipescu, MD
  • Russian Federation
      • Saint Petersburg, Russian Federation
        • Suspended
        • Saint-Petersburg State University Hospital
  • Singapore
      • Singapore, Singapore
  • South Africa
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2196
        • Active, not recruiting
        • Charlotte Maxeke Johannesburg Academic Hospital
  • Spain
      • Valencia, Spain
        • Recruiting
        • Hospital General Universitari de València
        • Contact:
        • Contact:
          • Joaquin Moreno-Pachon, MD
      • Valencia, Spain
        • Recruiting
        • Hospital Universitario La Fe Valencia
        • Contact:
        • Contact:
          • Paula Carmona Garcia, MD
    • Catalonia
      • Barcelona, Catalonia, Spain, 08025
        • Recruiting
        • Hospital De La Santa Creu I Sant Pau
        • Contact:
        • Contact:
          • Ana Maria Gomez Caro, MD
  • Switzerland
      • Basel, Switzerland, 4054
        • Recruiting
        • University Hospital Basel
        • Contact:
        • Contact:
          • Daniel Bolliger, MD
      • Bern, Switzerland, 3010
        • Recruiting
        • Inselspital, University Hospital Bern, University of Bern
        • Contact:
        • Contact:
          • Gabor Erdoes, MD
  • United Kingdom
      • Brighton, United Kingdom, BN2 1ES
        • Recruiting
        • University Hospitals Sussex NHS Foundation Trust
        • Contact:
          • Michael Lewis, MD
        • Contact:
      • Bristol, United Kingdom
        • Recruiting
        • University Hospitals Bristol and Weston NHS Foundation Trust
        • Contact:
        • Contact:
          • Ben Gibbison, MD
      • Cambridge, United Kingdom
        • Recruiting
        • Royal Papworth Hospital NHS Foundation Trust.
        • Contact:
          • Andrew klein, MD
        • Contact:
      • Wythenshawe, United Kingdom, M23 9QZ
        • Recruiting
        • Manchester University NHS Foundation Trust
        • Contact:
        • Contact:
          • Seema Agarwal, MD
    • East Midlands
      • Leicester, East Midlands, United Kingdom, LE3 9QP
        • Recruiting
        • University Hospital Leicester
        • Contact:
        • Contact:
          • Gavin Murphy, MD
    • Essex
      • Basildon, Essex, United Kingdom
        • Recruiting
        • Basildon University Hospitals-Mid and South Essex NHS Trust
        • Contact:
        • Contact:
          • Kunal Waghmare, MD
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO16 6YD
        • Recruiting
        • University Hospital Southampton Foundation Trust
        • Contact:
        • Contact:
          • Paul Diprose, MD
  • United States
    • Maine
      • Portland, Maine, United States, 04102
        • Recruiting
        • Maine Medical Center
        • Contact:
        • Contact:
          • Robert Kramer, MD
    • New Jersey
      • Camden, New Jersey, United States, 08103
    • New York
      • New York, New York, United States, 10032
        • Not yet recruiting
        • Columbia University
        • Contact:
        • Contact:
          • Aaron Mittel, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Active, not recruiting
        • Thomas Jefferson University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Within 6 months after cardiac surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Within 6 months after cardiac surgery.
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).
Up to hospital discharge or after 28 days postoperatively, whichever comes first.
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.
Up to hospital discharge or after 28 days postoperatively, whichever comes first.
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.
Up to hospital discharge or after 28 days postoperatively, whichever comes first.
Duration of mechanical ventilation.
Time Frame: Up to hospital discharge or after 28 days postoperatively, whichever comes first.
Time on mechanical ventilation.
Up to hospital discharge or after 28 days postoperatively, whichever comes first.
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.
Up to hospital discharge or after 28 days postoperatively, whichever comes first.
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.
Up to hospital discharge or after 28 days postoperatively, whichever comes first.
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.
Up to hospital discharge or after 28 days postoperatively, whichever comes first.
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.
Up to hospital discharge or after 28 days postoperatively, whichever comes first.
Hospital visits.
Time Frame: Within 6 months after cardiac surgery.
Hospitalization and/or emergency visits and coronary revascularization after index procedure.
Within 6 months after cardiac surgery.
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).
Up to hospital discharge or after 28 days postoperatively, whichever comes first.
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.
Up to hospital discharge or after 28 days postoperatively, whichever comes first.
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.
Up to hospital discharge or after 28 days postoperatively, whichever comes first.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unity Health Toronto

Investigators

  • Principal Investigator: David Mazer, MD, Unity Health Toronto
  • Principal Investigator: Nadine Shehata, MD, Mount Sinai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

February 9, 2021

First Submitted That Met QC Criteria

February 9, 2021

First Posted (Actual)

February 15, 2021

Study Record Updates

Last Update Posted (Estimated)

November 21, 2024

Last Update Submitted That Met QC Criteria

November 18, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TRICS-IV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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