AnemiaEICOTRANS-pNCT03782623
Effect of Packed Red Blood Cell Transfusion on Eicosanoid Profiles in Plasma of Intensive Care Patients
An observational study of Anemia and Critical Illness, run by Medical University of Vienna at 1 site in Austria.
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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Anemia, Critical Illness, Lung Transplantation
- What is being tested?
- Analysis of eicosanoid profile prior to and after PRBC transfusion
- How many people
- 23 participants
- Where
- 1 siteAustria
- Study dates
- 1 Dec 2018to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
None listed.
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Packed Red Blood Cell Transfusion on Eicosanoid Profiles in Plasma of Intensive Care Patients - a Pilot Study
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.
- Conditions
- Anemia, Critical Illness, Lung Transplantation, Open Aortic Surgery
- Being tested
- Analysis of eicosanoid profile prior to and after PRBC transfusion
- Medical subject headings
- Anemia, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Intensive care patients after elective open aortic surgery | Not described Receives: Diagnostic Test: Analysis of eicosanoid profile prior to and after PRBC transfusion | |
| Intensive care patients after bilateral lung transplantation | Not described Receives: Diagnostic Test: Analysis of eicosanoid profile prior to and after PRBC transfusion | |
| Anesthetic intensive care patients, unplanned admission | Not described Receives: Diagnostic Test: Analysis of eicosanoid profile prior to and after PRBC transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of plasma eicosanoid concentrations in ICU patients subjected to PRBC Transfusion at any time Point compared to baseline
Measured: 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
Measured: 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
Measured: 60 minutes prior to 90 minutes after packed red blood cell transfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study start1 Dec 2018
- Primary completion19 Mar 2020
- Study completion31 Dec 2022
Why it stopped: Slow recruitment secondary to limited capacity during Covid-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David M Baron, MD, PhD, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03782623
- Sponsor's protocol ID
- 1595/2018
- Acronym
- EICOTRANS-p
- Status last verified
- May 2023
- First submitted
- 16 Sep 2018
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38195728
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Packed Red Blood Cell Transfusion on Eicosanoid Profiles in Plasma of Intensive Care Patients - a Pilot Study
- ClinicalTrials.gov ID
- NCT03782623
- Acronym / sponsor ID
- EICOTRANS-p / 1595/2018
- Conditions
- Anemia, Critical Illness, Lung Transplantation, Open Aortic Surgery
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Slow recruitment secondary to limited capacity during Covid-19 pandemic
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 19 Mar 2020 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 20 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Analysis of eicosanoid profile prior to and after PRBC transfusionUsing liquid chromatography-mass spectrometry to analyze the eicosanoid profile in patient plasma and aliquoted of the PRBCs prior to and after PRBC transfusion. | Diagnostic test | Anesthetic intensive care patients, unplanned admission, Intensive care patients after bilateral lung transplantation, Intensive care patients after elective open aortic surgery |
Primary outcome
Change of plasma eicosanoid concentrations in ICU patients subjected to PRBC Transfusion at any time Point compared to baseline
Time frame: 60 minutes prior to 90 minutes after packed red blood cell transfusion
2 secondary outcomes
Changes of plasma eicosanoid profiles after PRBC transfusion compared to prior to PRBC transfusion in ICU patients
Time frame: 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
Time frame: 60 minutes prior to 90 minutes after packed red blood cell transfusion
Results and safety
The study was stopped early (reason given: Slow recruitment secondary to limited capacity during Covid-19 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
- Derived from this study: PubMed 38195728Raeven 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia and Critical Illness, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow recruitment secondary to limited capacity during Covid-19 pandemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of plasma eicosanoid concentrations in ICU patients subjected to PRBC Transfusion at any time Point compared to baseline (time frame: 60 minutes prior to 90 minutes after packed red blood cell transfusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03782623, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2023.