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NCT Number: NCT06102590

Oxygen Extraction-guided Transfusion

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.

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Key information

Conditions

Blood Transfusion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Erasme, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Individualized red blood cell transfusion strategy

Other

Prescription of RCBT is restricted to patients who present Hb ≤ 9.0 g/dL and O2ER ≥ 30%.

European guidelines red blood cell transfusion strategy

Other

RBCT according to ESICM guidelines

Primary outcomes

  1. Acute Kidney Injury (AKI)

    Time frame: 7-day after study inclusion

    Primary outcome will be the incidence of AKI, according to KDIGO latest definitions

Secondary outcomes

  1. 90-day mortality

    Time frame: 90-day after study inclusion

  2. proportion of patients undergoing RBCT, despite adequate/low O2ER

    Time frame: 28 days

    Patients receiving RBCT with O2ER<30%

  3. SOFA score variations

    Time frame: 5 days

    SOFA score at study inclusion-SOFA score at day 5

  4. variations in myocardial-specific troponin

    Time frame: 24 hours after study inclusion

    variations in myocardial-specific troponin

  5. days on vasopressors

    Time frame: 28 days

    number of days on vasopressor therapy

  6. Major Adverse Kidney Events by 90 days (MAKE90)

    Time frame: 90 days

    composite of death, new renal replacement therapy, or persistent renal dysfunction

  7. ICU mortality

    Time frame: through study completion, an average of 180 days

    ICU mortality

  8. In-hospital mortality

    Time frame: through study completion, an average of 180 days

    In-hospital mortality

Sponsors and collaborators

Lead sponsor

Università degli Studi di Ferrara

Other

Registry information

Official study title

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

Acronym: OXYTRIP

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Oct 26, 2023
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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