Oxygen Extraction-guided Transfusion

NCT06102590 · tracked via the Priya Life Science Belgium tracker

Sponsor

Università degli Studi di Ferrara

Phase

Not applicable

Started

2023-11-04

Last updated

2026-07-31

Condition(s) studied

Blood Transfusion

Investigational drug(s) / intervention(s)

Individualized red blood cell transfusion strategyEuropean guidelines red blood cell transfusion strategy

Individualized red blood cell transfusion strategy: Prescription of RCBT is restricted to patients who present Hb ≤ 9.0 g/dL and O2ER ≥ 30%.

European guidelines red blood cell transfusion strategy: RBCT according to ESICM guidelines

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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). Exclusion Criteria: * 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

Primary outcome measure(s)

Acute Kidney Injury (AKI) — 7-day after study inclusion
Primary outcome will be the incidence of AKI, according to KDIGO latest definitions

Trial sites (4)

Facility	City	Region	Status
Hospital Erasme	Brussels	Belgium	Recruiting
Università di Ferrara	Ferrara	Ferrara	Recruiting
Università di Perugia	Perugia	Italy	Recruiting
Anestesia e Rianimazione Cardio-Toraco-Vascolare	Siena	Italy	Recruiting

More Università degli Studi di Ferrara trials in Belgium

Iron Deficiency at ICU Discharge Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06102590 on ClinicalTrials.gov ↗ ← All trials in Belgium