NCT03782623

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 20, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2020

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

May 17, 2023

Status Verified

May 1, 2023

Enrollment Period

1.3 years

First QC Date

September 16, 2018

Last Update Submit

May 15, 2023

Conditions

AnemiaCritical IllnessLung TransplantationOpen Aortic Surgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

Study Arms (3)

Intensive care patients after elective open aortic surgery

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

Intensive care patients after bilateral lung transplantation

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

Anesthetic intensive care patients, unplanned admission

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

Interventions

Analysis of eicosanoid profile prior to and after PRBC transfusionDIAGNOSTIC_TEST

Using liquid chromatography-mass spectrometry to analyze the eicosanoid profile in patient plasma and aliquoted of the PRBCs prior to and after PRBC transfusion.

Anesthetic intensive care patients, unplanned admissionIntensive care patients after bilateral lung transplantationIntensive care patients after elective open aortic surgery

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (1)

  • Raeven P, Karlhofer K, Sztulman LS, Brugger J, Hoetzenecker K, Domenig C, Leitner G, Posch M, Baron DM, Spittler A. Red blood cell transfusion-related dynamics of extracellular vesicles in intensive care patients: a prospective subanalysis. Sci Rep. 2024 Jan 9;14(1):911. doi: 10.1038/s41598-023-48251-w.

    PMID: 38195728DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples

MeSH Terms

Conditions

AnemiaCritical Illness

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

September 16, 2018

First Posted

December 20, 2018

Study Start

December 1, 2018

Primary Completion

March 19, 2020

Study Completion

December 31, 2022

Last Updated

May 17, 2023

Record last verified: 2023-05

Locations

AU(1)