Oxygen Extraction-guided Transfusion

Официальное название

Oxygen Extraction-guided Transfusion Strategy in Critically Ill Patients. A Randomized Controlled Trial.

Обзор

In critically ill patients, optimized strategies for red blood cells transfusion (RBCT) are still controversial. Most recent guidelines suggest that clinical practice in ICU setting should follow a restrictive approach to RBCT (i.e., hemoglonim level \< 7.0 g/dL).In our previous study, oxygen extraction ratio (O2ER) has shown good performance as a marker to identify the correct timing for RBCT, potentially affecting 90-day mortality in non-bleeding, critically ill patients \[11\]. Moreover, our data suggested that an individualized strategy for RBCT may reduce the incidence of acute kidney injury (AKI), which is possibly related to a better delivery of oxygen and organ perfusion.

Вмешательства

• Другое Individualized red blood cell transfusion strategy
  Prescription of RCBT is restricted to patients who present Hb ≤ 9.0 g/dL and O2ER ≥ 30%.
• Другое European guidelines red blood cell transfusion strategy
  RBCT according to ESICM guidelines

Первичные конечные точки

• Acute Kidney Injury (AKI) [Срок оценки: 7-day after study inclusion]

Вторичные конечные точки (8)

• 90-day mortality [Срок оценки: 90-day after study inclusion]
• proportion of patients undergoing RBCT, despite adequate/low O2ER [Срок оценки: 28 days]
• SOFA score variations [Срок оценки: 5 days]
• variations in myocardial-specific troponin [Срок оценки: 24 hours after study inclusion]
• days on vasopressors [Срок оценки: 28 days]
• Major Adverse Kidney Events by 90 days (MAKE90) [Срок оценки: 90 days]
• ICU mortality [Срок оценки: through study completion, an average of 180 days]
• In-hospital mortality [Срок оценки: through study completion, an average of 180 days]

Критерии участия

Критерии включения

• Hb levels ≤ 9.0 g/dL (as confirmed through a blood test and/or through blood gas analysis)
• Presence of an arterial line and a central venous line (either jugular or subclavian), with confirmed correct position of the catheter tip at the atrio-caval junction (allowing correct estimation of central venous saturation, ScvO2).

Критерии исключения

• Age < 18 years;
• Pregnancy
• Clinical evidence of acute bleeding
• Diagnosis of haematological malignancy
• Diagnosis of sickle cell disease, or other diseases exposing the patient to chronic RCBTs
• Acquired or congenital disorders of coagulation
• Patients with ongoing AKI of stage 1 or worse and/or known chronic kidney disease (CKD) of stage G3a or worse, defined as glomerular filtration rate below 60 for a minimum of 3 months

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

Тройное слепое

Основная цель

Другое

Центры проведения

Италия · 3 центра

• Università di Ferrara — Ferrara
• Università di Perugia — Perugia
• Anestesia e Rianimazione Cardio-Toraco-Vascolare — Siena

Бельгия · 1 центр

• Hospital Erasme — Brussels

Публикации

• Fogagnolo A, Azzolina D, Taccone FS, Pedarzani E, Pasa G, Marianello D, Valpiani G, Marchesini C, Annoni F, Moureau A, Volta CA, Franchi F, Spadaro S. Oxygen extraction-guided transfusion strategy in critically ill patients: study protocol for a randomised, open-labelled, controlled trial. BMJ Open. 2024 Nov 12;14(11):e089910. doi: 10.1136/bmjopen-2024-089910. PMID 39532348

Идентификаторы

NCT: NCT06102590 · OXYTRIP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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