Clinical trial NCT04754022: Transfusion Requirements in Younger Patients Undergoing Cardiac Surgery
Official title: An International, Multi-centre, Randomized Controlled Trial to Assess Transfusion Thresholds in Younger Patients Undergoing Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Disorder
Heart
Postoperative
Cardiac Surgery
Keywords: Cardiac Surgery
Transfusion
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2021-02-15
Enrollment: 1440
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: 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).
timeFrame: Within 6 months after cardiac surgery.
Secondary outcomes:
measure: 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).
timeFrame: Within 6 months after cardiac surgery.
measure: Composite and individual all-cause mortality, myocardial infarction, new onset renal failure requiring dialysis, and new focal neurological deficit (stroke).
timeFrame: Up to hospital discharge or after 28 days postoperatively, whichever comes first.
measure: Length of stay in the ICU and hospital.
timeFrame: Up to hospital discharge or after 28 days postoperatively, whichever comes first.
measure: Prolonged low output state.
timeFrame: Up to hospital discharge or after 28 days postoperatively, whichever comes first.
measure: Duration of mechanical ventilation.
timeFrame: Up to hospital discharge or after 28 days postoperatively, whichever comes first.
measure: Incidence of infection.
timeFrame: Up to hospital discharge or after 28 days postoperatively, whichever comes first.
measure: Acute kidney injury.
timeFrame: Up to hospital discharge or after 28 days postoperatively, whichever comes first.
measure: Delirium.
timeFrame: Up to hospital discharge or after 28 days postoperatively, whichever comes first.
measure: Incidence of gut infarction.
timeFrame: Up to hospital discharge or after 28 days postoperatively, whichever comes first.
measure: Hospital visits.
timeFrame: Within 6 months after cardiac surgery.
measure: Transfusion requirements.
timeFrame: Up to hospital discharge or after 28 days postoperatively, whichever comes first.
measure: Incidence of seizures.
timeFrame: Up to hospital discharge or after 28 days postoperatively, whichever comes first.
measure: Incidence of encephalopathy.
timeFrame: Up to hospital discharge or after 28 days postoperatively, whichever comes first.
Other outcomes:
Locations:
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Camden
country: United States
facility: The Cooper Health System
state: New Jersey
city: New York
country: United States
facility: Columbia University
state: New York
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Camperdown
country: Australia
facility: Royal Prince Alfred hospital
state: New South Wales
city: Randwick
country: Australia
facility: Prince of Wales Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Southport
country: Australia
facility: Gold Coast University Hospital
state: Queensland
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Clayton
country: Australia
facility: Monash Health
state: Victoria
city: Fitzroy
country: Australia
facility: St Vincent's Hospital Melbourne
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
city: Melbourne
country: Australia
facility: Royal Melbourne Hospital
city: Prahran
country: Australia
facility: Alfred Hospital
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Kelowna
country: Canada
facility: Interior Health Kelowna General Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Saint John
country: Canada
facility: Saint John Regional Hospitall
state: New Brunswick
city: Hamilton
country: Canada
facility: Hamilton Health Sciences Centre / Hamilton General Hospital
state: Ontario
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre
state: Ontario
city: Sudbury
country: Canada
facility: Health Sciences North Research Institute
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Center
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital, Unity Health Toronto
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Montréal
country: Canada
facility: Centre hospitalier de l'Université de Montréal
state: Quebec
city: Montréal
country: Canada
facility: Hôpital Sacré-Cœur de Montréal
state: Quebec
city: Québec
country: Canada
facility: Institut universitaire de cardiologie et de pneumology de Québec - université Laval (IUCPQ-UL)
state: Quebec
city: Bogota
country: Colombia
facility: Hospital Universitario San Ignacio
city: Bogota
country: Colombia
facility: Fundacion Abood Shaio
city: Bogota
country: Colombia
facility: Fundacion Cardioinfantil
city: Naşr
country: Egypt
facility: Nasr City Health Insurance Hospital
state: Cairo
city: Alexandroupolis
country: Greece
facility: Democritus University of Thrace
state: Evros
city: Ahmedabad
country: India
facility: EPIC Hospital
state: Gujrat
city: Windhoek
country: Namibia
facility: Windhoek Central Hospital
state: Khomas
city: Kathmandu
country: Nepal
facility: Shahid Gangalal National Heart Center
city: Bucharest
country: Romania
facility: Emergency Institute of Cardiovascular Diseases
city: Saint Petersburg
country: Russian Federation
facility: Saint-Petersburg State University Hospital
city: Singapore
country: Singapore
facility: National Heart Centre
city: Johannesburg
country: South Africa
facility: Charlotte Maxeke Johannesburg Academic Hospital
state: Gauteng
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu I Sant Pau
state: Catalonia
city: Valencia
country: Spain
facility: Hospital General Universitari de Valencia
city: Valencia
country: Spain
facility: Hospital Universitario La Fe Valencia
city: Basel
country: Switzerland
facility: University Hospital Basel
city: Bern
country: Switzerland
facility: Inselspital, University Hospital Bern, University of Bern
city: Leicester
country: United Kingdom
facility: University Hospital Leicester
state: East Midlands
city: Basildon
country: United Kingdom
facility: Basildon University Hospitals-Mid and South Essex NHS Trust
state: Essex
city: Southampton
country: United Kingdom
facility: University Hospital Southampton Foundation Trust
state: Hampshire
city: Brighton
country: United Kingdom
facility: University Hospitals Sussex NHS Foundation Trust
city: Bristol
country: United Kingdom
facility: University Hospitals Bristol and Weston NHS Foundation Trust
city: Cambridge
country: United Kingdom
facility: Royal Papworth Hospital NHS Foundation Trust.
city: Wythenshawe
country: United Kingdom
facility: Manchester University NHS Foundation Trust
Study officials:
affiliation: Unity Health Toronto
name: David Mazer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MOUNT SINAI HOSPITAL
name: Nadine Shehata, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.