Oxygen Extraction-guided Transfusion (OXYTRIP)

April 27, 2026 updated by: Alberto Fogagnolo, Università degli Studi di Ferrara

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

324

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium
        • Not yet recruiting
        • Hospital Erasme
        • Contact:
          • Fabio Silvio Taccone
  • Italy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Individualized RBCT
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
Prescription of RCBT is restricted to patients who present Hb ≤ 9.0 g/dL and O2ER ≥ 30%.
Active Comparator: Control group
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
RBCT according to ESICM guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute Kidney Injury (AKI)
Time Frame: 7-day after study inclusion
Primary outcome will be the incidence of AKI, according to KDIGO latest definitions
7-day after study inclusion

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università degli Studi di Ferrara

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 4, 2023

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

October 18, 2023

First Submitted That Met QC Criteria

October 24, 2023

First Posted (Actual)

October 26, 2023

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • OXYTRIP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

To be shared under reasonable requests.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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