Guided transfusion strategy for critically ill patients
Oxygen Extraction-guided Transfusion Strategy in Critically Ill Patients. A Randomized Controlled Trial.
NA · Università degli Studi di Ferrara · NCT06102590
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 324 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Università degli Studi di Ferrara (other) |
| Locations | 4 sites (Brussels and 3 other locations) |
| Trial ID | NCT06102590 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Previous studies have indicated that individualized transfusion strategies may improve outcomes, suggesting potential success for this approach.
Eligibility criteria
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 this trial is running
Brussels and 3 other locations
- Hospital Erasme — Brussels, Belgium (NOT_YET_RECRUITING)
- Università di Ferrara — Ferrara, Ferrara, Italy (RECRUITING)
- Università di Perugia — Perugia, Italy, Italy (RECRUITING)
- Anestesia e Rianimazione Cardio-Toraco-Vascolare — Siena, Italy (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Blood Transfusion