Oxygen Extraction-guided Transfusion

Not Applicable

Recruiting

• Conditions: Blood Transfusion

• 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

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