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

Study Overview
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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.

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

Conditions
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Critical Illness, Anemia, Lung Transplantation, Open Aortic Surgery

Intervention / Treatment
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* Diagnostic Test: Analysis of eicosanoid profile prior to and after PRBC transfusion


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intensive care patients after elective open aortic surgery<br> | Diagnostic Test: Analysis of eicosanoid profile prior to and after PRBC transfusion<br>* Using liquid chromatography-mass spectrometry to analyze the eicosanoid profile in patient plasma and aliquoted of the PRBCs prior to and after PRBC transfusion.<br>|
| Intensive care patients after bilateral lung transplantation<br> | Diagnostic Test: Analysis of eicosanoid profile prior to and after PRBC transfusion<br>* Using liquid chromatography-mass spectrometry to analyze the eicosanoid profile in patient plasma and aliquoted of the PRBCs prior to and after PRBC transfusion.<br>|
| Anesthetic intensive care patients, unplanned admission<br> | Diagnostic Test: Analysis of eicosanoid profile prior to and after PRBC transfusion<br>* Using liquid chromatography-mass spectrometry to analyze the eicosanoid profile in patient plasma and aliquoted of the PRBCs prior to and after PRBC transfusion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |