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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,440
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.
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.
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).
Time frame: Within 6 months after cardiac surgery.
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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Up to hospital discharge or after 28 days postoperatively, whichever comes first.
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Maine Medical Center
Portland, Maine, United States
RECRUITINGThe Cooper Health System
Camden, New Jersey, United States
RECRUITINGColumbia University
New York, New York, United States
NOT_YET_RECRUITINGThomas Jefferson University
Philadelphia, Pennsylvania, United States
ACTIVE_NOT_RECRUITINGRoyal Adelaide Hospital
Adelaide, Adelaide, Australia
RECRUITINGRoyal Prince Alfred hospital
Camperdown, New South Wales, Australia
RECRUITINGPrince of Wales Hospital
Randwick, New South Wales, Australia
RECRUITINGWestmead Hospital
Westmead, New South Wales, Australia
RECRUITINGGold Coast University Hospital
Southport, Queensland, Australia
RECRUITINGFlinders Medical Centre
Bedford Park, South Australia, Australia
RECRUITING...and 44 more locations
Duration of mechanical ventilation.
Time on mechanical ventilation.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Within 6 months after cardiac surgery.
Transfusion requirements.
The proportion of patients transfused and the number of blood products utilized (RBCs, plasma, platelets).
Time frame: 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.
Time frame: 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.
Time frame: Up to hospital discharge or after 28 days postoperatively, whichever comes first.