Oxygen Extraction-guided Transfusion

Blood Transfusion Clinical Trial

— OXYTRIP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06102590
• Other study ID #: OXYTRIP
• Status: Recruiting
• Phase: N/A
• Start date: November 4, 2023
• Est. completion date: September 1, 2025

Study information

• Verified date: February 2024
• Source: Università degli Studi di Ferrara
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 324
• Est. completion date: September 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Blood Transfusion

Intervention

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

Locations

Country	Name	City	State
Belgium	Hospital Erasme	Bruxelles
Italy	Università di Ferrara	Ferrara
Italy	Anestesia e Rianimazione Cardio-Toraco-Vascolare	Siena

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi di Ferrara

Countries where clinical trial is conducted

Belgium,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute Kidney Injury (AKI)	Primary outcome will be the incidence of AKI, according to KDIGO latest definitions	7-day after study inclusion
Secondary	90-day mortality		90-day after study inclusion
Secondary	proportion of patients undergoing RBCT, despite adequate/low O2ER	Patients receiving RBCT with O2ER<30%	28 days
Secondary	SOFA score variations	SOFA score at study inclusion-SOFA score at day 5	5 days
Secondary	variations in myocardial-specific troponin	variations in myocardial-specific troponin	24 hours after study inclusion
Secondary	days on vasopressors	number of days on vasopressor therapy	28 days
Secondary	Major Adverse Kidney Events by 90 days (MAKE90)	composite of death, new renal replacement therapy, or persistent renal dysfunction	90 days
Secondary	ICU mortality	ICU mortality	through study completion, an average of 180 days
Secondary	In-hospital mortality	In-hospital mortality	through study completion, an average of 180 days