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/39532348Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06102590
Oxygen Extraction-guided Transfusion Strategy in Critically Ill Patients A Randomized Controlled Trial
Led by Università degli Studi di Ferrara · Updated on 2026-05-01
324
Participants Needed
4
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating transfusion strategies in critically ill patients to determine the best approach for red blood cell transfusions (RBCT). The study compares an individualized strategy guided by oxygen extraction ratio (O2ER) with a standard restrictive approach based on hemoglobin levels. This trial aims to explore whether using O2ER to guide RBCT can reduce acute kidney injury and affect mortality in non-bleeding critically ill adults. The trial includes two groups: one receiving transfusions when hemoglobin is 9.0 g/dL or lower and O2ER is 30% or higher, with ongoing monitoring to guide further transfusions; and a control group using current European guidelines recommending transfusions at hemoglobin levels of 7.0 g/dL or lower, regardless of O2ER. Patients are monitored daily for hemoglobin and oxygen extraction, with transfusions mandatory if hemoglobin drops below 6.0 g/dL. Participants will have daily blood tests and catheter monitoring to measure oxygen levels and hemoglobin. Researchers will track kidney injury seven days after enrollment and observe secondary outcomes like mortality at 90 days, organ function scores, heart injury markers, and time on blood pressure support. Safety and survival will be followed for about six months. The study aims to gather detailed data on the effects of these transfusion strategies in critically ill patients.
CONDITIONS
Brief Title
Oxygen Extraction-guided Transfusion
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Hemoglobin levels 9.0 g/dL or lower confirmed by blood test or blood gas analysis
- Presence of an arterial line and a central venous line with correct catheter tip position for measuring central venous oxygen saturation
- Age 18 years or older
You will not qualify if you...
- Age under 18 years
- Pregnancy
- Clinical evidence of acute bleeding
- Diagnosis of hematological malignancy
- Diagnosis of sickle cell disease or other conditions requiring chronic red blood cell transfusions
- Acquired or congenital coagulation disorders
- Ongoing acute kidney injury stage 1 or worse, or chronic kidney disease stage G3a or worse with glomerular filtration rate below 60 for at least 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 28 days after study inclusion
Participants receive daily assessments of hemoglobin levels and oxygen extraction ratio, with red blood cell transfusions given according to assigned strategies.
Daily assessments during treatment period
Follow-up
Duration - Up to 180 days after study inclusion
Participants are monitored for outcomes including kidney injury, mortality, and other health measures following treatment.
Periodic follow-up visits up to 180 days
Trial Site Locations
Total: 4 locations
1
Hospital Erasme
Brussels, Belgium
Not Yet Recruiting
2
Università di Ferrara
Ferrara, Ferrara, Italy, 44121
Actively Recruiting
3
Università di Perugia
Perugia, Italy, Italy, 06121
Actively Recruiting
4
Anestesia e Rianimazione Cardio-Toraco-Vascolare
Siena, Italy
Actively Recruiting
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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