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.
Brief Title
Transfusion Requirements in Younger Patients Undergoing Cardiac Surgery
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
416-864-5825
Central Contact Email
David.Mazer@unityhealth.to
Completion Date
Completion Date Type
Estimated
Conditions
Disorder
Heart
Postoperative
Cardiac Surgery
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)
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)
Inclusion 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
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
Gender
All
Gender Based
false
Keywords
Cardiac Surgery
Transfusion
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
65 Years
Minimum Age
18 Years
NCT Id
NCT04754022
Org Class
Other
Org Full Name
Unity Health Toronto
Org Study Id
TRICS-IV
Overall Status
Recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
An International, Multi-centre, Randomized Controlled Trial to Assess Transfusion Thresholds in Younger Patients Undergoing Cardiac Surgery
Primary Outcomes
Outcome Description
Any of all-cause mortality, myocardial infarction, new onset renal failure requiring dialysis, or new focal neurological deficit (stroke).
Outcome 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).
Outcome Time Frame
Within 6 months after cardiac surgery.
Secondary Outcomes
Outcome Description
Incidence of all-cause mortality, myocardial infarction, new onset renal failure requiring dialysis, and new focal neurological deficit (stroke).
Outcome Time Frame
Within 6 months after cardiac surgery.
Outcome 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).
Outcome Description
Composite and individual incidence of all-cause mortality, myocardial infarction, new onset renal failure requiring dialysis, and new focal neurological deficit (stroke).
Outcome Time Frame
Up to hospital discharge or after 28 days postoperatively, whichever comes first.
Outcome Measure
Composite and individual all-cause mortality, myocardial infarction, new onset renal failure requiring dialysis, and new focal neurological deficit (stroke).
Outcome Description
Length of stay in the ICU and hospital in days.
Outcome Time Frame
Up to hospital discharge or after 28 days postoperatively, whichever comes first.
Outcome Measure
Length of stay in the ICU and hospital.
Outcome Description
Defined as the need for two or more inotropes for 24 hours or more, intra-aortic balloon pump or ventricular assist device postoperatively.
Outcome Time Frame
Up to hospital discharge or after 28 days postoperatively, whichever comes first.
Outcome Measure
Prolonged low output state.
Outcome Description
Time on mechanical ventilation.
Outcome Time Frame
Up to hospital discharge or after 28 days postoperatively, whichever comes first.
Outcome Measure
Duration of mechanical ventilation.
Outcome Description
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.
Outcome Time Frame
Up to hospital discharge or after 28 days postoperatively, whichever comes first.
Outcome Measure
Incidence of infection.
Outcome Description
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.
Outcome Time Frame
Up to hospital discharge or after 28 days postoperatively, whichever comes first.
Outcome Measure
Acute kidney injury.
Outcome Description
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.
Outcome Time Frame
Up to hospital discharge or after 28 days postoperatively, whichever comes first.
Outcome Measure
Delirium.
Outcome Description
Confirmed by imaging (e.g. angiography), autopsy, or through surgical means.
Outcome Time Frame
Up to hospital discharge or after 28 days postoperatively, whichever comes first.
Outcome Measure
Incidence of gut infarction.
Outcome Description
Hospitalization and/or emergency visits and coronary revascularization after index procedure.
Outcome Time Frame
Within 6 months after cardiac surgery.
Outcome Measure
Hospital visits.
Outcome Description
The proportion of patients transfused and the number of blood products utilized (RBCs, plasma, platelets).
Outcome Time Frame
Up to hospital discharge or after 28 days postoperatively, whichever comes first.
Outcome Measure
Transfusion requirements.
Outcome Description
Generalized or focal tonic-clonic movements consistent with seizure; or electroencephalogram demonstrating epileptiform discharges; or diagnosis of seizures by neurologist or neurosurgeon consultation.
Outcome Time Frame
Up to hospital discharge or after 28 days postoperatively, whichever comes first.
Outcome Measure
Incidence of seizures.
Outcome Description
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.
Outcome Time Frame
Up to hospital discharge or after 28 days postoperatively, whichever comes first.
Outcome Measure
Incidence of encephalopathy.
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
65
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Dr. Jonathan Leff