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OpenTrials
Completed

NCT Number: NCT03767127

Oxygen Extraction-guided Transfusion in Critically Ill Patients

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.

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Key information

Conditions

Anemia Critical Illness Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Università di Ferrara

Ferrara, 44121, Italy

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. 90-day mortality

    Time frame: after 90 days from study enrollment

    mortality

Secondary outcomes

  1. Acute kidney injury

    Time frame: 7 days after study inclusion

    Occurence of acute kidney injury according to KDIGO 2012 guidelines

  2. Length of ICU stay

    Time frame: from ICU admission to discharge, up to 8 weeks

  3. Variation in Sequential Organ Failure Assessment (SOFA) score

    Time frame: 5 days

    daily variation in SOFA score (0-24 points scale with higher values indicating worst conditions)

  4. Days of vasopressor

    Time frame: 28 days after study inclusion

    Need for vasopressor

Sponsors and collaborators

Lead sponsor

Università degli Studi di Ferrara

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 6, 2018
Registry last updated
Nov 21, 2019

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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