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Oxygen Extraction-guided Transfusion

ConditionBlood Transfusion
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversità degli Studi di Ferrara

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

Age < 18 years;

Pregnancy

Clinical evidence of acute bleeding

Diagnosis of haematological malignancy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Individualized red blood cell transfusion strategy

    Other intervention

    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 intervention

    RBCT according to ESICM guidelines

Treatment groups

324 Participants
are divided into 2 treatment groups
Group A: Individualized RBCTExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Acute Kidney Injury (AKI)

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

Time frame
7-day after study inclusion

Secondary outcomes

1

90-day mortality

Time frame
90-day after study inclusion
2

proportion of patients undergoing RBCT, despite adequate/low O2ER

Patients receiving RBCT with O2ER\<30%

Time frame
28 days
3

SOFA score variations

SOFA score at study inclusion-SOFA score at day 5

Time frame
5 days
4

variations in myocardial-specific troponin

variations in myocardial-specific troponin

Time frame
24 hours after study inclusion

Other outcomes

Sponsors and contacts

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Università degli Studi di Ferrara

Lead sponsor

Source ClinicalTrials.gov
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