Transfusion Requirements in Younger Patients Undergoing Cardiac Surgery

Study Overview
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Brief Summary
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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.

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

Conditions
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Disorder, Heart, Postoperative, Cardiac Surgery

Intervention / Treatment
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* Other: Restrictive Transfusion Strategy
* Other: Liberal transfusion strategy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥18 and ≤65 years of age Planned cardiac surgery using cardiopulmonary bypass Informed consent obtained Preoperative European System for Cardiac Operative Risk Evaluation (EuroSCORE I) of 6 or more Exclusion Criteria: Patients who refuse participation Patients who are unable to receive or who refuse blood products Patients who are involved in a preoperative autologous pre-donation program Patients who are having a heart transplant or having surgery solely for an insertion of a ventricular assist device Pregnancy or lactation (a negative pregnancy test must be obtained prior to randomization for women of childbearing potential)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Restrictive Transfusion Strategy<br>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<br>* 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.<br>|
| Active Comparator: Liberal Transfusion Strategy<br>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<br>* 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.<br>|

What is the study measuring?
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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). | 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). | 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). | 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. | 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. | 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 on mechanical ventilation. | Up to hospital discharge or after 28 days postoperatively, whichever comes first. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| Hospital visits. | Hospitalization and/or emergency visits and coronary revascularization after index procedure. | Within 6 months after cardiac surgery. | 
| 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. | 
| 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. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac Surgery, Transfusion