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

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ClinicalTrials.gov Identifier: NCT03782623
Recruitment Status : Active, not recruiting
First Posted : December 20, 2018
Last Update Posted : January 5, 2021
Sponsor:
Information provided by (Responsible Party):
David M Baron, MD, Medical University of Vienna

Study Description
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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
Anemia Critical Illness Lung Transplantation Open Aortic Surgery Diagnostic Test: Analysis of eicosanoid profile prior to and after PRBC transfusion

Study Design
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Study Type : Observational
Estimated 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 : December 1, 2018
Actual Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

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Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Biospecimen Retention:   Samples Without DNA
Plasma samples

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03782623


Locations
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Austria
Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: David M Baron, MD, Principle Investigator, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT03782623    
Other Study ID Numbers: 1595/2018
First Posted: December 20, 2018    Key Record Dates
Last Update Posted: January 5, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes