Oxygen extraction-guided transfusion strategy in critically ill patients: study protocol for a randomised, open-labelled, controlled trial.
Alberto Fogagnolo, Danila Azzolina, Fabio Silvio Taccone...
https://pubmed.ncbi.nlm.nih.gov/39532348/Actively Recruiting
Led by Università degli Studi di Ferrara · Updated on 2026-07-31
324
Participants Needed
4
Research Sites
12 weeks
Total Duration
Researchers are evaluating optimized red blood cell transfusion RBCT strategies in critically ill patients to determine the best timing and approach. The study compares an individualized transfusion strategy guided by oxygen extraction ratio O2ER against the standard European guideline approach. Prior data suggest that using O2ER may help reduce acute kidney injury AKI and affect 90-day mortality by improving oxygen delivery and organ perfusion. Participants are assigned to one of two groups the individualized RBCT group, where transfusions are given based on hemoglobin Hb levels and O2ER, with transfusion thresholds adjusted accordingly and the control group, which follows European guidelines with transfusions given when Hb is at or below 7.0 gdL regardless of O2ER. Daily assessments of Hb and O2ER are performed, and transfusions are managed according to specific criteria in each group. Transfusion with Hb below 6.0 gdL is mandatory in all cases. During the study, participants receive daily monitoring of Hb and O2ER, and clinicians document transfusion decisions. Researchers will measure outcomes including AKI within 7 days of inclusion, 90-day mortality, use of vasopressors, and other clinical markers such as myocardial troponin and SOFA score variations. Mortality will be tracked during an average of 180 days. The study aims to follow participants from enrollment until study completion, with ongoing assessment of kidney events and transfusion practices.
CONDITIONS
Oxygen Extraction-guided Transfusion
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Università degli Studi di Ferrara
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Duration of ICU stay or as clinically indicated
Participants receive red blood cell transfusions based on either individualized oxygen extraction ratio-guided strategy or standard European guidelines. Daily assessments of hemoglobin and oxygen extraction ratio guide transfusion decisions.
Daily assessments and monitoring
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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Alberto Fogagnolo, Danila Azzolina, Fabio Silvio Taccone...
https://pubmed.ncbi.nlm.nih.gov/39532348/Università degli Studi di Ferrara
Lead Sponsor