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

Terminated

• Conditions: Critical Illness; Lung Transplantation; Anemia; Open Aortic Surgery
• Interventions: Diagnostic Test: Analysis of eicosanoid profile prior to and after PRBC transfusion

• Registration Number: NCT03782623
• Lead Sponsor: Medical University of Vienna

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-16
• Study Start: 2018-12-01
• Study First Submitted QC: 2018-12-19
• Study First Posted: 2018-12-20
• Primary Completion: 2020-03-19
• Study Completion: 2022-12-31
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-15
• Last Update Posted: 2023-05-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

Not provided

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intensive care patients after elective open aortic surgery	Analysis of eicosanoid profile prior to and after PRBC transfusion	-
Intensive care patients after bilateral lung transplantation	Analysis of eicosanoid profile prior to and after PRBC transfusion	-
Anesthetic intensive care patients, unplanned admission	Analysis of eicosanoid profile prior to and after PRBC transfusion	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria