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

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: Critical Illness; Anemia; Lung Transplantation; Open Aortic Surgery
• Intervention / Treatment: Diagnostic test: Analysis of eicosanoid profile prior to and after PRBC transfusion

• Study Type: Observational
• Enrollment (Actual): 23

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

3

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	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	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	60 minutes prior to 90 minutes after packed red blood cell transfusion

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Study record dates

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: Pathologic Processes; Disease Attributes; Critical Illness
• 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