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New oxygen-based test could prevent kidney damage from blood transfusions in ICU

NCT ID NCT06102590

Disease control Sponsor: Università degli Studi di Ferrara Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 31, 2026 · Updated 2 times

Summary

This study tests whether using a measure called oxygen extraction ratio (O2ER) to guide blood transfusions can reduce kidney injury in critically ill patients. About 324 ICU patients with low hemoglobin will be randomly assigned to receive transfusions based on O2ER levels or standard guidelines. The goal is to see if this personalized approach improves outcomes like kidney function and survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
red blood cell transfusion guided by oxygen extraction ratio
What this could lead to
If successful, this could lead to a safer, more personalized way to decide when ICU patients need a blood transfusion, potentially reducing kidney damage.
What could go wrong
This is a mid-sized trial (324 participants) and the approach is still experimental. The benefit may be small or not apply to all critically ill patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 324 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2023

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Blood transfusion

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Anestesia e Rianimazione Cardio-Toraco-Vascolare

    RECRUITING

    Siena, Italy

  • Hospital Erasme

    RECRUITING

    Brussels, Belgium

  • Università di Ferrara

    RECRUITING

    Ferrara, Ferrara, 44121, Italy

  • Università di Perugia

    RECRUITING

    Perugia, Italy, 06121, Italy

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