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

Anemia Clinical Trial

— EICOTRANS-p  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03782623
• Other study ID #: 1595/2018
• Status: Terminated
• Start date: December 1, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2023
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: December 31, 2022
• Est. primary completion date: March 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Critical Illness
• Lung Transplantation
• Open Aortic Surgery

Intervention

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.

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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