An interventional study of Restrictive Transfusion Strategy and Liberal transfusion strategy in Disorder, Heart and Postoperative, sponsored by Unity Health Toronto. Recruiting at 54 sites in 16 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-11-21.
Sponsored by Unity Health Toronto · Not applicable, Interventional, and Treatment
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.
Unity Health Toronto is the lead sponsor of 447 studies on the registry; 82 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
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Plan to share: No
Started Nov 2021 (actual). Primary completion is estimated for Dec 2025, 49 months after the start.
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