Oxygen Extraction-guided Transfusion

NCT06102590 | Recruiting DMC

• 1 other identifier: OXYTRIP
• Study Type: interventional
• Target: 324
• Locations: 2 countries
• Sites: 4

Brief Summary

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.

Conditions

Blood Transfusion

Outcome Measures

Primary Outcomes (1)

• Acute Kidney Injury (AKI)

  Primary outcome will be the incidence of AKI, according to KDIGO latest definitions

  7-day after study inclusion

Secondary Outcomes (8)

• 90-day mortality

  90-day after study inclusion

• proportion of patients undergoing RBCT, despite adequate/low O2ER

  28 days

• SOFA score variations

  5 days

• variations in myocardial-specific troponin

  24 hours after study inclusion

• days on vasopressors

  28 days

Study Arms (2)

Individualized RBCT

EXPERIMENTAL

Requires daily assessment of hemoglobin (Hb) levels. Prescription of RCBT is restricted to patients who present Hb ≤ 9.0 g/dL and O2ER ≥ 30%. If O2ER \< 30%, transfusion will take place only when Hb falls below 7.0 g/dL. Further O2ER measurements during the day in this group are allowed, and the clinician should not be blinded of the results. To tolerate Hb levels below 7.0 g/dL with O2ER \< 30% remains a clinical decision, documented in the CRF. Transfusion with Hb below 6.0 g/dL is mandatory

Other: Individualized red blood cell transfusion strategy

Control group

ACTIVE COMPARATOR

Requires daily assessment of hemoglobin levels. Prescription of RCBT is restricted to patients who present Hb ≤ 7.0 g/dL, despite of O2ER values. Indeed, O2ER calculation takes place at least once daily in this group but does not interfere with clinical decision to prescribe RBCT. A liberal transfusion threshold (i.e. 9.0 g/dL) is still possible in critically ill adults with acute coronary syndromes, as indicated by the European current guidelines

Other: European guidelines red blood cell transfusion strategy

Interventions

Individualized red blood cell transfusion strategy OTHER

Prescription of RCBT is restricted to patients who present Hb ≤ 9.0 g/dL and O2ER ≥ 30%.

Individualized RBCT

European guidelines red blood cell transfusion strategy OTHER

RBCT according to ESICM guidelines

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Università degli Studi di Ferrara: lead

Study Sites (4)

Hospital Erasme

Brussels, Belgium

NOT YET RECRUITING

Università di Ferrara

Ferrara, Ferrara, 44121, Italy

RECRUITING

Università di Perugia

Perugia, Italy, 06121, Italy

RECRUITING

Anestesia e Rianimazione Cardio-Toraco-Vascolare

Siena, Italy

RECRUITING

Related Publications (1)

• 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 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: October 26, 2023
• Study Start: November 4, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

BE (1); IT (3)