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Oxygen Extraction-guided Transfusion in Critically Ill Patients

Red Blood Cell Transfusion Decision Based on Arterial-venous Oxygen Difference Can Reduce Mortality in Critically Ill Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03767127
Enrollment
177
Registered
2018-12-06
Start date
2017-07-01
Completion date
2018-12-30
Last updated
2019-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Critical Illness

Keywords

transfusion, intensive care medicine, 90-day mortality

Brief summary

Anemia is common in intensive care unit (ICU) patients and often appears early in the ICU course. The optimal management red blood cells RBC transfusion in critically ill patients remains controversial and clinical studies in this field have usually been based on transfusion thresholds. In the TRICC Trial, patients assigned to a restrictive transfusion strategy (transfusion if Hb\<7 g/dL) had similar mortality to patients transfused if Hb\<10 g/dL. Notably, none of the large RCT tried to focus on a personalize RBC transfusion protocol, i.e. a transfusion protocol which address the individual need for transfusion basing on physiological approach. We therefore hypothesized that patients with high extraction of oxygen could benefit more of RBCs transfusion regardless their hemoglobin levels.

Interventions

None listed

Sponsors

Università degli Studi di Ferrara
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Hemoglobin level \<10 g/dL during the first 72 hours of ICU

Exclusion criteria

* Acute bleeding * Hemoglobin level less than 7 g/dL

Design outcomes

Primary

MeasureTime frameDescription
90-day mortalityafter 90 days from study enrollmentmortality

Secondary

MeasureTime frameDescription
Acute kidney injury7 days after study inclusionOccurence of acute kidney injury according to KDIGO 2012 guidelines
Length of ICU stayfrom ICU admission to discharge, up to 8 weeks
Variation in Sequential Organ Failure Assessment (SOFA) score5 daysdaily variation in SOFA score (0-24 points scale with higher values indicating worst conditions)
Days of vasopressor28 days after study inclusionNeed for vasopressor

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026