Effect of Packed Red Blood Cell Transfusion on Eicosanoid Profiles in Plasma of Intensive Care Patients (EICOTRANS-p)

Medical University of Vienna

Status: Terminated

Conditions: Anemia; Critical Illness; Lung Transplantation; Open Aortic Surgery

Treatments: Diagnostic Test: Analysis of eicosanoid profile prior to and after PRBC transfusion

Study type: Observational

Funder types: Other

Identifiers

NCT03782623

1595/2018

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

23 participants in 3 patient groups

Intensive care patients after elective open aortic surgery

Treatment:

Diagnostic Test: Analysis of eicosanoid profile prior to and after PRBC transfusion

Intensive care patients after bilateral lung transplantation

Treatment:

Diagnostic Test: Analysis of eicosanoid profile prior to and after PRBC transfusion

Anesthetic intensive care patients, unplanned admission

Treatment:

Diagnostic Test: Analysis of eicosanoid profile prior to and after PRBC transfusion