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

Sponsor

Medical University of Vienna (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03782623

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Anemia Critical Illness Lung Transplantation Open Aortic Surgery	Diagnostic Test: Analysis of eicosanoid profile prior to and after PRBC transfusion

Study Design

Study Type:

Observational

Anticipated Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Dec 1, 2018

Actual Primary Completion Date :

Dec 31, 2020

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Vienna	Vienna		Austria	1090

Sponsors and Collaborators

Medical University of Vienna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

David M Baron, MD, Principle Investigator, Medical University of Vienna

ClinicalTrials.gov Identifier:

NCT03782623

Other Study ID Numbers:

1595/2018

First Posted:

Dec 20, 2018

Last Update Posted:

Apr 11, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Critical Illness

Study Results

No Results Posted as of Apr 11, 2022