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

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03782623
Acronym
EICOTRANS-p
Enrollment
23
Registered
2018-12-20
Start date
2018-12-01
Completion date
2022-12-31
Last updated
2023-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Critical Illness, Lung Transplantation, Open Aortic Surgery

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. 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.

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.

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change of plasma eicosanoid concentrations in ICU patients subjected to PRBC Transfusion at any time Point compared to baseline60 minutes prior to 90 minutes after packed red blood cell transfusion

Secondary

MeasureTime frame
Changes of plasma eicosanoid profiles after PRBC transfusion compared to prior to PRBC transfusion in ICU patients60 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 patients60 minutes prior to 90 minutes after packed red blood cell transfusion

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026