Oxygen Extraction-guided Transfusion in Critically Ill Patients

November 19, 2019 updated by: Alberto Fogagnolo, Università degli Studi di Ferrara

Red Blood Cell Transfusion Decision Based on Arterial-venous Oxygen Difference Can Reduce Mortality 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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

177

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Ferrara, Italy, 44121
        • Università di Ferrara

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Unselected critically ill patients admitted to intensive care unit

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Appropriate transfusion policy
Patients transfused with high arterial-venous oxygen difference (≥3.7 ml/dl) or non-transfused with low arterial-venous oxygen difference (<3.7 ml/dl)
Non-Appropriate transfusion policy
Patients transfused despite low arterial-venous oxygen difference or non-transfused with high arterial-venous oxygen difference

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
90-day mortality
Time Frame: after 90 days from study enrollment
mortality
after 90 days from study enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute kidney injury
Time Frame: 7 days after study inclusion
Occurence of acute kidney injury according to KDIGO 2012 guidelines
7 days after study inclusion
Length of ICU stay
Time Frame: from ICU admission to discharge, up to 8 weeks
from ICU admission to discharge, up to 8 weeks
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)
5 days
Days of vasopressor
Time Frame: 28 days after study inclusion
Need for vasopressor
28 days after study inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università degli Studi di Ferrara

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2017

Primary Completion (Actual)

October 1, 2018

Study Completion (Actual)

December 30, 2018

Study Registration Dates

First Submitted

November 30, 2018

First Submitted That Met QC Criteria

December 5, 2018

First Posted (Actual)

December 6, 2018

Study Record Updates

Last Update Posted (Actual)

November 21, 2019

Last Update Submitted That Met QC Criteria

November 19, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OEDT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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