Effect of Packed Red Blood Cell Transfusion on Eicosanoid Profiles in Plasma of Intensive Care Patients (EICOTRANS-p)

May 15, 2023 updated by: David M Baron, MD, PhD, Medical University of Vienna

Effect of Packed Red Blood Cell Transfusion on Eicosanoid Profiles in Plasma of Intensive Care Patients - a Pilot Study

The main goal of this pilot study is to assess the time course of eicosanoid profiles in intensive care unit (ICU) patients requiring packed red blood cell (PRBC) transfusion. Moreover we will analyze the change of levels of eicosanoids in patient plasma prior and after a PRBC transfusion as well as its correlation with levels of eicosanoids in the transfused PRBCs. These data will then be used to determine the estimated effect size necessary for the planning of future larger studies. We hypothesize that transfusion of PRBCs will modulate the eicosanoid profile in ICU patients.

According to the Protocol filed with the Institutional Review Board of the Medical University of Vienna and patient's informed consent, subsequent sub analyses using samples of this study (e.g., determination of extracellular vesicles in PRBC samples and patient's plasma) will be performed.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

23

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

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna

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 to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Group 1: routine postoperative ICU patients after open aortic surgery Group 2: routine postoperative ICU patients with immunosuppression after lung transplantation Group 3: mixed postoperative ICU patients

Description

Exclusion Criteria:

  • Age <18 years or >99 years
  • Pregnancy
  • <12h since last PRBC transfusion
  • intake/administration of acetylsalicylic acid in groups 2 and 3
  • intake/administration of cysteinyl leukotriene receptor antagonists (e.g. montelukast)
  • intake/administration of celecoxib, etoricoxib, parecoxib, ibuprofen, diclofenac, and naproxen in all groups
  • glucocorticoids given within 24h of transfusion in groups 1 and 3
  • treatment with calcineurin inhibitors (e.g. tacrolimus) in groups 1 and 3
  • treatment with alemtuzumab in groups 1 and 3
  • administration of protamine for heparin reversal in groups 2 and 3

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Intensive care patients after elective open aortic surgery
Diagnostic test: Analysis of eicosanoid profile prior to and after PRBC transfusion
Using liquid chromatography-mass spectrometry to analyze the eicosanoid profile in patient plasma and aliquoted of the PRBCs prior to and after PRBC transfusion.
Intensive care patients after bilateral lung transplantation
Diagnostic test: Analysis of eicosanoid profile prior to and after PRBC transfusion
Using liquid chromatography-mass spectrometry to analyze the eicosanoid profile in patient plasma and aliquoted of the PRBCs prior to and after PRBC transfusion.
Anesthetic intensive care patients, unplanned admission
Diagnostic test: Analysis of eicosanoid profile prior to and after PRBC transfusion
Using liquid chromatography-mass spectrometry to analyze the eicosanoid profile in patient plasma and aliquoted of the PRBCs prior to and after PRBC transfusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of plasma eicosanoid concentrations in ICU patients subjected to PRBC Transfusion at any time Point compared to baseline
Time Frame: 60 minutes prior to 90 minutes after packed red blood cell transfusion
60 minutes prior to 90 minutes after packed red blood cell transfusion

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes of plasma eicosanoid profiles after PRBC transfusion compared to prior to PRBC transfusion in ICU patients
Time Frame: 60 minutes prior to 90 minutes after packed red blood cell transfusion
60 minutes prior to 90 minutes after packed red blood cell transfusion
Correlation of plasma eicosanoid profiles in the transfused PRBCs and the change of their plasma levels in ICU patients
Time Frame: 60 minutes prior to 90 minutes after packed red blood cell transfusion
60 minutes prior to 90 minutes after packed red blood cell transfusion

Collaborators and Investigators

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

Sponsor

Medical University of Vienna

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)

December 1, 2018

Primary Completion (Actual)

March 19, 2020

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

September 16, 2018

First Submitted That Met QC Criteria

December 19, 2018

First Posted (Actual)

December 20, 2018

Study Record Updates

Last Update Posted (Actual)

May 17, 2023

Last Update Submitted That Met QC Criteria

May 15, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1595/2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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