Transfusion Requirements in Younger Patients Undergoing Cardiac Surgery

Cardiac Surgery Clinical Trial

— TRICS-IV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04754022
• Other study ID #: TRICS-IV
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: January 2024

Study information

• Verified date: February 2022
• Source: Unity Health Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1440
• Est. completion date: January 2024
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cardiac Surgery
• Disorder
• Heart
• Postoperative

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences Centre / Hamilton General Hospital	Hamilton	Ontario
Canada	Interior Health Kelowna General Hospital	Kelowna	British Columbia
Canada	Centre hospitalier de l'Université de Montréal	Montréal	Quebec
Canada	Institut universitaire de cardiologie et de pneumology de Québec - université Laval (IUCPQ-UL)	Québec	Quebec
Canada	Saint John Regional Hospitall	Saint John	New Brunswick
Canada	St. Michael's Hospital, Unity Health Toronto	Toronto	Ontario
Russian Federation	Saint-Petersburg State University Hospital	Saint Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
Unity Health Toronto

Countries where clinical trial is conducted

Canada,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	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	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).	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.
Secondary	Composite and individual all-cause mortality, myocardial infarction, new onset renal failure requiring dialysis, and new focal neurological deficit (stroke).	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.
Secondary	Length of stay in the ICU and hospital.	Length of stay in the ICU and hospital in days.	Up to hospital discharge or after 28 days postoperatively, whichever comes first.
Secondary	Prolonged low output state.	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.
Secondary	Duration of mechanical ventilation.	Time on mechanical ventilation.	Up to hospital discharge or after 28 days postoperatively, whichever comes first.
Secondary	Incidence of infection.	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.
Secondary	Acute kidney injury.	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.
Secondary	Delirium.	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.
Secondary	Incidence of gut infarction.	Confirmed by imaging (e.g. angiography), autopsy, or through surgical means.	Up to hospital discharge or after 28 days postoperatively, whichever comes first.
Secondary	Hospital visits.	Hospitalization and/or emergency visits and coronary revascularization after index procedure.	Within 6 months after cardiac surgery.
Secondary	Transfusion requirements.	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.
Secondary	Incidence of seizures.	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.
Secondary	Incidence of encephalopathy.	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.