Oxygen Extraction-guided Transfusion

Not Applicable

Recruiting

• Conditions: Blood Transfusion
• Interventions: Other: Individualized red blood cell transfusion strategy; Other: European guidelines red blood cell transfusion strategy

• Registration Number: NCT06102590
• Lead Sponsor: Università degli Studi di Ferrara

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-18
• Study First Submitted QC: 2023-10-24
• Study First Posted: 2023-10-26
• Study Start: 2023-11-04
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-24
• Last Update Posted: 2024-02-28
• Primary Completion: 2025-06-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 324

Inclusion Criteria

• Evidence of Hb levels ≤ 9.0 g/dL (as confirmed through a blood test and/or through blood gas analysis);
• Presence of a central venous line (either jugular or subclavear), with confirmed correct position of the catheter tip at the atriocaval junction (allowing correct estimation of mixed venous saturation, SvO2).

Exclusion Criteria

• Age < 18 years;
• Female patients during pregnancy;
• Clinical evidence of acute ongoing/persistent bleeding;
• Diagnosis of hematological 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 and/or known chronic kidney disease (CKD).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Individualized RBCT	Individualized red blood cell transfusion strategy	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
Control group	European guidelines red blood cell transfusion strategy	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

Primary Outcome Measures

Name	Time	Method
Acute Kidney Injury (AKI)	7-day after study inclusion	Primary outcome will be the incidence of AKI, according to KDIGO latest definitions

Secondary Outcome Measures

Name	Time	Method
days on vasopressors	28 days	number of days on vasopressor therapy
In-hospital mortality	through study completion, an average of 180 days	In-hospital mortality
variations in myocardial-specific troponin	24 hours after study inclusion	variations in myocardial-specific troponin
proportion of patients undergoing RBCT, despite adequate/low O2ER	28 days	Patients receiving RBCT with O2ER\<30%
SOFA score variations	5 days	SOFA score at study inclusion-SOFA score at day 5
Major Adverse Kidney Events by 90 days (MAKE90)	90 days	composite of death, new renal replacement therapy, or persistent renal dysfunction
ICU mortality	through study completion, an average of 180 days	ICU mortality
90-day mortality	90-day after study inclusion

Trial Locations

Locations (3)

Hospital Erasme; 🇧🇪 Bruxelles, Belgium

Università di Ferrara; 🇮🇹 Ferrara, Italy

Anestesia e Rianimazione Cardio-Toraco-Vascolare; 🇮🇹 Siena, Italy