Oxygen Extraction-guided Transfusion (OXYTRIP)

Università degli Studi di Ferrara

Status: Enrolling

Conditions: Blood Transfusion

Treatments: Other: European guidelines red blood cell transfusion strategy; Other: Individualized red blood cell transfusion strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT06102590

OXYTRIP

Details and patient eligibility

About

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.

Enrollment: 324 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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324 participants in 2 patient groups

Individualized RBCT

Experimental group

Description:

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

Treatment:

Other: Individualized red blood cell transfusion strategy

Control group

Active Comparator group

Description:

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

Treatment:

Other: European guidelines red blood cell transfusion strategy