Transfusion Requirements in Younger Patients Undergoing Cardiac Surgery

Официальное название

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

Обзор

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.

Вмешательства

• Другое Restrictive 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.
• Другое Liberal 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.

Первичные конечные точки

• 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). [Срок оценки: Within 6 months after cardiac surgery.]

Вторичные конечные точки (12)

• 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). [Срок оценки: 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). [Срок оценки: Up to hospital discharge or after 28 days postoperatively, whichever comes first.]
• Length of stay in the ICU and hospital. [Срок оценки: Up to hospital discharge or after 28 days postoperatively, whichever comes first.]
• Prolonged low output state. [Срок оценки: Up to hospital discharge or after 28 days postoperatively, whichever comes first.]
• Duration of mechanical ventilation. [Срок оценки: Up to hospital discharge or after 28 days postoperatively, whichever comes first.]
• Incidence of infection. [Срок оценки: Up to hospital discharge or after 28 days postoperatively, whichever comes first.]
• Acute kidney injury. [Срок оценки: Up to hospital discharge or after 28 days postoperatively, whichever comes first.]
• Delirium. [Срок оценки: Up to hospital discharge or after 28 days postoperatively, whichever comes first.]
• Incidence of gut infarction. [Срок оценки: Up to hospital discharge or after 28 days postoperatively, whichever comes first.]
• Hospital visits. [Срок оценки: Within 6 months after cardiac surgery.]
• Transfusion requirements. [Срок оценки: Up to hospital discharge or after 28 days postoperatively, whichever comes first.]
• Incidence of seizures. [Срок оценки: Up to hospital discharge or after 28 days postoperatively, whichever comes first.]

Критерии участия

Критерии включения

• ≥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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Канада · 15 центров

• University of Alberta Hospital — Edmonton
• Interior Health Kelowna General Hospital — Kelowna
• Vancouver General Hospital — Vancouver
• Saint John Regional Hospitall — Saint John
• Health Sciences North Research Institute — Greater Sudbury
• Hamilton Health Sciences Centre / Hamilton General Hospital — Hamilton
• Kingston Health Sciences Centre — Kingston
• Sunnybrook Health Sciences Center — Toronto
• … и ещё 7 центров

Австралия · 11 центров

• Royal Adelaide Hospital — Adelaide
• Royal Prince Alfred hospital — Camperdown
• Prince of Wales Hospital — Randwick
• Westmead Hospital — Westmead
• Gold Coast University Hospital — Southport
• Flinders Medical Centre — Bedford Park
• Monash Health — Clayton
• St Vincent's Hospital Melbourne — Fitzroy
• … и ещё 3 центра

Великобритания · 7 центров

• University Hospital Leicester — Leicester
• Basildon University Hospitals-Mid and South Essex NHS Trust — Basildon
• University Hospital Southampton Foundation Trust — Southampton
• University Hospitals Sussex NHS Foundation Trust — Brighton
• University Hospitals Bristol and Weston NHS Foundation Trust — Bristol
• Royal Papworth Hospital NHS Foundation Trust. — Cambridge
• Manchester University NHS Foundation Trust — Wythenshawe

США · 4 центра

• Maine Medical Center — Portland
• The Cooper Health System — Camden
• Columbia University — New York
• Thomas Jefferson University — Philadelphia

Колумбия · 3 центра

• Hospital Universitario San Ignacio — Bogotá
• Fundacion Abood Shaio — Bogotá
• Fundacion Cardioinfantil — Bogotá

Испания · 3 центра

• Hospital de la Santa Creu I Sant Pau — Barcelona
• Hospital General Universitari de Valencia — Valencia
• Hospital Universitario La Fe Valencia — Valencia

Швейцария · 2 центра

• Inselspital, University Hospital Bern, University of Bern — Bern
• University Hospital Basel — Basel

Египет · 1 центр

• Nasr City Health Insurance Hospital — Naşr

Греция · 1 центр

• Democritus University of Thrace — Alexandroupoli

Индия · 1 центр

• EPIC Hospital — Ahmedabad

Namibia · 1 центр

• Windhoek Central Hospital — Windhoek

Nepal · 1 центр

• Shahid Gangalal National Heart Center — Kathmandu

Румыния · 1 центр

• Emergency Institute of Cardiovascular Diseases — Bucharest

Россия · 1 центр

• Saint-Petersburg State University Hospital — Saint Petersburg

Сингапур · 1 центр

• National Heart Centre — Singapore

ЮАР · 1 центр

• Charlotte Maxeke Johannesburg Academic Hospital — Johannesburg

Публикации

• 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. PMID 41114449
• 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. PMID 34932836

Идентификаторы

NCT: NCT04754022 · TRICS-IV

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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