Oxygen Extraction-guided Transfusion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

324 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-04

Study Completion Date

2027-01-01

Brief Summary

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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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Detailed Description

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Conditions

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Blood Transfusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Individualized red blood cell transfusion strategy

Intervention Type OTHER

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

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

Group Type ACTIVE_COMPARATOR

European guidelines red blood cell transfusion strategy

Intervention Type OTHER

RBCT according to ESICM guidelines

Interventions

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Individualized red blood cell transfusion strategy

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

Intervention Type OTHER

European guidelines red blood cell transfusion strategy

RBCT according to ESICM guidelines

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No