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TerminatedNCT03782623EICOTRANS-pUpdated May 17, 2023

Effect of Packed Red Blood Cell Transfusion on Eicosanoid Profiles in Plasma of Intensive Care Patients

An observational study in Anemia, Critical Illness and Lung Transplantation, sponsored by Medical University of Vienna. Terminated at 1 site in Austria. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-05-17.

Sponsored by Medical University of Vienna · Observational

Why this study was terminated
Slow recruitment secondary to limited capacity during Covid-19 pandemic
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
23
Ages
18 Years to 99 Years
Sex
All
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Study summary

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.

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Conditions studied

  • Anemia
  • Critical Illness
  • Lung Transplantation
  • Open Aortic Surgery

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03

In context

Critical Illness

1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.

This study's enrollment of 23 is below the median of 130 across 867 observational studies indexed under Critical Illness.

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Lead sponsor

Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
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

Eligibility criteria

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
23 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Intensive care patients after elective open aortic surgery

    Diagnostic Test: Analysis of eicosanoid profile 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

  • Anesthetic intensive care patients, unplanned admission

    Diagnostic Test: Analysis of eicosanoid profile prior to and after PRBC transfusion

Interventions

  • Diagnostic testAnalysis 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.

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What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

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Study locations

1 site
  • Medical University of Vienna
    Vienna, 1090, Austria
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 17, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03782623
Lead sponsor
Medical University of Vienna
Responsible party
David M Baron, MD, PhD (Principle Investigator, Medical University of Vienna) — Principal investigator
First posted
Dec 20, 2018
Start date
Dec 1, 2018
Primary completion
Mar 19, 2020
Completion
Dec 31, 2022
Last update
May 17, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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