RecruitingNot ApplicableNCT06102590

Oxygen Extraction-guided Transfusion

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


Sponsor

Università degli Studi di Ferrara

Enrollment

324 participants

Start Date

Nov 4, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria2

  • 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 Criteria7

  • 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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Interventions

OTHERIndividualized red blood cell transfusion strategy

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

OTHEREuropean guidelines red blood cell transfusion strategy

RBCT according to ESICM guidelines


Locations(4)

Hospital Erasme

Brussels, Belgium

Università di Ferrara

Ferrara, Ferrara, Italy

Università di Perugia

Perugia, Italy, Italy

Anestesia e Rianimazione Cardio-Toraco-Vascolare

Siena, Italy

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NCT06102590


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