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

NCT ID: NCT03782623

Last Updated: 2023-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-01

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Anemia Critical Illness Lung Transplantation Open Aortic Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Intensive care patients after elective open aortic surgery

Analysis of eicosanoid profile prior to and after PRBC transfusion

Intervention Type DIAGNOSTIC_TEST

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

Analysis of eicosanoid profile prior to and after PRBC transfusion

Intervention Type DIAGNOSTIC_TEST

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

Analysis of eicosanoid profile prior to and after PRBC transfusion

Intervention Type DIAGNOSTIC_TEST

Using liquid chromatography-mass spectrometry to analyze the eicosanoid profile in patient plasma and aliquoted of the PRBCs prior to and after PRBC transfusion.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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David M Baron, MD, PhD

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Medical University of Vienna

Vienna, , Austria

Site Status

Countries

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Austria

References

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Raeven P, Karlhofer K, Sztulman LS, Brugger J, Hoetzenecker K, Domenig C, Leitner G, Posch M, Baron DM, Spittler A. Red blood cell transfusion-related dynamics of extracellular vesicles in intensive care patients: a prospective subanalysis. Sci Rep. 2024 Jan 9;14(1):911. doi: 10.1038/s41598-023-48251-w.

Reference Type DERIVED
PMID: 38195728 (View on PubMed)

Other Identifiers

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1595/2018

Identifier Type: -

Identifier Source: org_study_id

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