Oxygen Extraction-guided Transfusion

Official title

Oxygen Extraction-guided Transfusion Strategy in Critically Ill Patients. A Randomized Controlled Trial.

Overview

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.

Interventions

• Other Individualized red blood cell transfusion strategy
  Prescription of RCBT is restricted to patients who present Hb ≤ 9.0 g/dL and O2ER ≥ 30%.
• Other European guidelines red blood cell transfusion strategy
  RBCT according to ESICM guidelines

Primary outcome measures

• Acute Kidney Injury (AKI) [Time frame: 7-day after study inclusion]

Secondary outcome measures (8)

• 90-day mortality [Time frame: 90-day after study inclusion]
• proportion of patients undergoing RBCT, despite adequate/low O2ER [Time frame: 28 days]
• SOFA score variations [Time frame: 5 days]
• variations in myocardial-specific troponin [Time frame: 24 hours after study inclusion]
• days on vasopressors [Time frame: 28 days]
• Major Adverse Kidney Events by 90 days (MAKE90) [Time frame: 90 days]
• ICU mortality [Time frame: through study completion, an average of 180 days]
• In-hospital mortality [Time frame: through study completion, an average of 180 days]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Other

Study locations

Italy · 3 centers

• Università di Ferrara — Ferrara
• Università di Perugia — Perugia
• Anestesia e Rianimazione Cardio-Toraco-Vascolare — Siena

Belgium · 1 center

• Hospital Erasme — Brussels

Publications

• Fogagnolo A, Azzolina D, Taccone FS, Pedarzani E, Pasa G, Marianello D, Valpiani G, Marchesini C, Annoni F, Moureau A, Volta CA, Franchi F, Spadaro S. Oxygen extraction-guided transfusion strategy in critically ill patients: study protocol for a randomised, open-labelled, controlled trial. BMJ Open. 2024 Nov 12;14(11):e089910. doi: 10.1136/bmjopen-2024-089910. PMID 39532348

Identifiers

NCT: NCT06102590 · OXYTRIP

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗