Guided transfusion strategy for critically ill patients
Official title: Oxygen Extraction-guided Transfusion Strategy in Critically Ill Patients. A Randomized Controlled Trial.
Run by Università degli Studi di Ferrara · NCT06102590 · Data updated 2026-11-12
This study is testing a personalized blood transfusion approach for critically ill patients to see if it can improve their chances of recovery compared to standard practices.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 324 (estimated) |
| Sponsor | Università degli Studi di Ferrara Academic / other |
| Locations | 4 sites (Brussels and 3 other locations) |
| Status | Recruiting |
| Started | November 4, 2023 |
| Main results expected | December 1, 2026 |
| Study ends | March 1, 2027 |
| Registry record updated | July 31, 2026 |
| Trial ID | NCT06102590 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are critically ill patients with hemoglobin levels of 9.0 g/dL or lower who have the necessary vascular access for monitoring.
✕Probably not a fit
Patients under 18 years old, pregnant women, or those with acute bleeding or certain chronic conditions will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates an individualized red blood cell transfusion strategy based on oxygen extraction ratios in critically ill patients. It aims to optimize transfusion practices by determining the appropriate timing for red blood cell transfusions, potentially improving patient outcomes such as reducing 90-day mortality and the incidence of acute kidney injury. The study will compare this individualized approach to standard European guidelines for transfusion. Eligible patients will have specific hemoglobin levels and vascular access for accurate monitoring.
Why it matters
Potential benefit: If successful, this approach could lead to improved survival rates and reduced complications for critically ill patients requiring blood transfusions.
How similar studies have gone: Previous studies have indicated that individualized transfusion strategies may improve outcomes, suggesting potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Hospital Erasme
Brussels, Belgium Recruiting -
Università di Ferrara
Ferrara, Ferrara, Italy Recruiting -
Università di Perugia
Perugia, Italy, Italy Recruiting -
Anestesia e Rianimazione Cardio-Toraco-Vascolare
Siena, Italy Recruiting
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Blood Transfusion Factors and Cell Saver Use in Kids’ Spine Surgery
This study looks at which factors put pediatric scoliosis patients at risk for needing donor blood during posterior spinal fusion and how using a Cell Saver during surgery might reduce that need.
-
Timing of hip fracture surgery for patients on DOAC blood thinners
This project will see if operating within 24 hours is as safe as delaying surgery for people with hip fractures who recently took DOAC blood thinners by comparing how often they need blood transfusions.
-
Predicting blood needs and hemolysis risk in children having heart surgery
This project will collect blood samples from children having heart surgery to try to build a mathematical model that predicts transfusion needs and hemolysis risk during surgery.
-
Managing shock in malnourished children with diarrhea
This study is testing whether blood transfusions and certain medications can help young children with severe malnutrition and diarrhea who are in shock feel better compared to regular fluid treatments.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.