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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Restrictive Transfusion Strategy | Active Comparator | 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. |
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| Liberal Transfusion Strategy | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Restrictive Transfusion Strategy | Other | 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. |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Mazer, MD | Contact | 416-864-5825 | David.Mazer@unityhealth.to |
| Name | Affiliation | Role |
|---|---|---|
| David Mazer, MD | Unity Health Toronto | Principal Investigator |
| Nadine Shehata, MD | MOUNT SINAI HOSPITAL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maine Medical Center | Recruiting | Portland | Maine | 04102 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41114449 | Derived | Carson JL, Stanworth SJ, Dennis JA, Fergusson DA, Pagano MB, Roubinian NH, Turgeon AF, Valentine S, Trivella M, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2025 Oct 20;10(10):CD002042. doi: 10.1002/14651858.CD002042.pub6. | |
| 34932836 | Derived |
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| Liberal transfusion strategy | Other | 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 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. |
| The Cooper Health System | Recruiting | Camden | New Jersey | 08103 | United States |
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| Columbia University | Not yet recruiting | New York | New York | 10032 | United States |
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| Thomas Jefferson University | Active, not recruiting | Philadelphia | Pennsylvania | 19107 | United States |
| Royal Adelaide Hospital | Recruiting | Adelaide | Adelaide | 5000 | Australia |
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| Royal Prince Alfred hospital | Recruiting | Camperdown | New South Wales | 2050 | Australia |
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| Prince of Wales Hospital | Recruiting | Randwick | New South Wales | 2024 | Australia |
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| Westmead Hospital | Recruiting | Westmead | New South Wales | 2145 | Australia |
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| Gold Coast University Hospital | Recruiting | Southport | Queensland | 4215 | Australia |
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| Flinders Medical Centre | Recruiting | Bedford Park | South Australia | 5042 | Australia |
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| Monash Health | Recruiting | Clayton | Victoria | 3168 | Australia |
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| St Vincent's Hospital Melbourne | Recruiting | Fitzroy | Victoria | 3065 | Australia |
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| Austin Health | Recruiting | Heidelberg | Victoria | 3084 | Australia |
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| Royal Melbourne Hospital | Recruiting | Melbourne | Australia |
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| Alfred Hospital | Recruiting | Prahran | 3181 | Australia |
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| University of Alberta Hospital | Recruiting | Edmonton | Alberta | T6G 2B7 | Canada |
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| Interior Health Kelowna General Hospital | Recruiting | Kelowna | British Columbia | V1Y 0C5 | Canada |
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| Vancouver General Hospital | Recruiting | Vancouver | British Columbia | V5Z 1M9 | Canada |
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| Saint John Regional Hospitall | Recruiting | Saint John | New Brunswick | E2L 4L2 | Canada |
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| Health Sciences North Research Institute | Recruiting | Greater Sudbury | Ontario | P3E 5J1 | Canada |
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| Hamilton Health Sciences Centre / Hamilton General Hospital | Recruiting | Hamilton | Ontario | L8L 2X2 | Canada |
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| Kingston Health Sciences Centre | Active, not recruiting | Kingston | Ontario | K7L 2V7 | Canada |
| Sunnybrook Health Sciences Center | Recruiting | Toronto | Ontario | M4N 3M5 | Canada |
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| St. Michael's Hospital, Unity Health Toronto | Recruiting | Toronto | Ontario | M5B 1W8 | Canada |
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| Toronto General Hospital | Recruiting | Toronto | Ontario | M5G 2C4 | Canada |
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| Montreal Heart Institute | Recruiting | Montreal | Quebec | H1T 1C8 | Canada |
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| Centre hospitalier de l'Université de Montréal | Recruiting | Montreal | Quebec | H2X 0C1 | Canada |
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| Jewish General Hospital | Recruiting | Montreal | Quebec | H3T 1E2 | Canada |
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| Hôpital Sacré-Cœur de Montréal | Recruiting | Montreal | Quebec | H4J 1C5 | Canada |
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| Institut universitaire de cardiologie et de pneumology de Québec - université Laval (IUCPQ-UL) | Recruiting | Québec | Quebec | G1V 4G5 | Canada |
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| Hospital Universitario San Ignacio | Recruiting | Bogotá | 110231 | Colombia |
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| Fundacion Abood Shaio | Recruiting | Bogotá | 111111 | Colombia |
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| Fundacion Cardioinfantil | Recruiting | Bogotá | Colombia |
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| Nasr City Health Insurance Hospital | Active, not recruiting | NaÅŸr | Cairo Governorate | 4450010 | Egypt |
| Democritus University of Thrace | Recruiting | Alexandroupoli | Evros | 68100 | Greece |
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| EPIC Hospital | Recruiting | Ahmedabad | Gujarat | 380060 | India |
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| Windhoek Central Hospital | Active, not recruiting | Windhoek | Khomas Region | 0000 | Namibia |
| Shahid Gangalal National Heart Center | Recruiting | Kathmandu | Kathmandu | 44600 | Nepal |
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| Emergency Institute of Cardiovascular Diseases | Recruiting | Bucharest | Romania | 022322 | Romania |
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| Saint-Petersburg State University Hospital | Suspended | Saint Petersburg | Russia |
| National Heart Centre | Recruiting | Singapore | Singapore |
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| Charlotte Maxeke Johannesburg Academic Hospital | Active, not recruiting | Johannesburg | Gauteng | 2196 | South Africa |
| Hospital de la Santa Creu I Sant Pau | Recruiting | Barcelona | Catalonia | 08025 | Spain |
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| Hospital General Universitari de Valencia | Recruiting | Valencia | Spain |
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| Hospital Universitario La Fe Valencia | Recruiting | Valencia | Spain |
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| Inselspital, University Hospital Bern, University of Bern | Recruiting | Bern | Canton of Bern | 3010 | Switzerland |
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| University Hospital Basel | Recruiting | Basel | 4054 | Switzerland |
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| University Hospital Leicester | Recruiting | Leicester | East Midlands | LE3 9QP | United Kingdom |
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| Basildon University Hospitals-Mid and South Essex NHS Trust | Recruiting | Basildon | Essex | United Kingdom |
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| University Hospital Southampton Foundation Trust | Recruiting | Southampton | Hampshire | SO16 6YD | United Kingdom |
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| University Hospitals Sussex NHS Foundation Trust | Recruiting | Brighton | BN2 1ES | United Kingdom |
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| University Hospitals Bristol and Weston NHS Foundation Trust | Recruiting | Bristol | United Kingdom |
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| Royal Papworth Hospital NHS Foundation Trust. | Recruiting | Cambridge | United Kingdom |
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| Manchester University NHS Foundation Trust | Recruiting | Wythenshawe | M23 9QZ | United Kingdom |
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| Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5. |
| ID | Term |
|---|---|
| D004194 | Disease |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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