Clinical trial NCT03782623: Effect of Packed Red Blood Cell Transfusion on Eicosanoid Profiles in Plasma of Intensive Care Patients
Official title: Effect of Packed Red Blood Cell Transfusion on Eicosanoid Profiles in Plasma of Intensive Care Patients - a Pilot Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Anemia
Critical Illness
Lung Transplantation
Open Aortic Surgery
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2018-12-20
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Group 1: routine postoperative ICU patients after open aortic surgery Group 2: routine postoperative ICU patients with immunosuppression after lung transplantation Group 3: mixed postoperative ICU patients

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.


Eligibility 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

Primary outcomes:
measure: Change of plasma eicosanoid concentrations in ICU patients subjected to PRBC Transfusion at any time Point compared to baseline
timeFrame: 60 minutes prior to 90 minutes after packed red blood cell transfusion
Secondary outcomes:
measure: Changes of plasma eicosanoid profiles after PRBC transfusion compared to prior to PRBC transfusion in ICU patients
timeFrame: 60 minutes prior to 90 minutes after packed red blood cell transfusion
measure: Correlation of plasma eicosanoid profiles in the transfused PRBCs and the change of their plasma levels in ICU patients
timeFrame: 60 minutes prior to 90 minutes after packed red blood cell transfusion
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References: