ARDSPLAIARNCT05098106
PLAIAR-Trial: Platelets in Inflammation and Resolution
An observational study of ARDS and Platelet Abnormality, run by University Hospital Muenster at 1 site in Germany.
Trial summary
Detection and determination of platelets in bronchoalveolar lavage fluid and blood in ARDS and non-ARDS-patients. Correlation with phenotype and inflammation parameters in blood and outcome parameters. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS, Platelet Abnormality
- What is being tested?
- Bronchoscopy, blood sampling; testing.
- How many people
- 72 participants
- Where
- 1 siteGermany
- Study dates
- 1 May 2021to Mar 2023
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Perioperative patients
Who may be able to join
- Routine bronchoscopy
- Patient in perioperative setting
- Age >=18 years
- Consent
Who cannot join
- Active or recent (in past 7 days) bleeding in upper airways
- Recent traumatic injury of the lung associated with (micro-)hemorrhage
- Blood aspiration
- Pregnancy
- Age<18 years
- Acute kidney injury / Chronic kidney failure / Dialysis
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- Transplantation
- HIV
- Hematologic diseases
- Immunosuppression
- Anti-Platelet-Therapy
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Muenster
Münster
Carola Wempe, Dr., +4925147255, wempe-c@anit.uni-muenster.de
Andreas Margraf, Dr., andreas.margraf@anit.uni-muenster.de
About this study
Official title: PlaIaR-Trial: Platelets in Inflammation and Resolution.
Detection and determination of platelets in bronchoalveolar lavage fluid and blood in ARDS and non-ARDS-patients. Correlation with phenotype and inflammation parameters in blood and outcome parameters.
- Conditions
- ARDS, Platelet Abnormality
- Being tested
- Bronchoscopy, blood sampling; testing.
- Medical subject headings
- Blood Platelet Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronchoscopy, blood sampling; testing.Diagnostic test
BAL and blood samples are measured by hematology analyzer, flow cytometry, western blot, RNAseq analysis and multiplex.
| Study group | Role | What they receive |
|---|---|---|
| Pneumonia patients with ARDS | Patients in the perioperative/intensive care setting with pneumonia-induced ARDS requiring bronchoscopy. Receives: Diagnostic Test: Bronchoscopy, blood sampling; testing. | |
| Ventilated patients without ARDS | Patients without ARDS on mechanical ventilation. Receives: Diagnostic Test: Bronchoscopy, blood sampling; testing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detectability and changes in platelets in BAL and blood
Measured: 5-7 days
Organ failure, survival.
Measured: 1 Year
Systemic platelet and leukocyte numbers
Measured: 5-7 days
Systemic platelet and leukocyte phenotypes.
Measured: 5-7 days
Systemic cytokine profiles.
Measured: 5-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start1 May 2021
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDSStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Collaborators
- Study Chair and Principal Investigator: Univ.-Prof. Dr. Alexander Zarbock, Principal Investigator: Dr. Andreas Margraf
- Responsible party
- Sponsor
- Investigators
- Alexander Zarbock, Univ.-Prof. Dr., Study chair, University Hospital MuensterAndreas Margraf, Dr., Principal investigator, University Hospital Muenster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05098106
- Sponsor's protocol ID
- 12-Anit-20
- Acronym
- PLAIAR
- Status last verified
- Oct 2021
- First submitted
- 18 Oct 2021
- Last updated
- 10 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PlaIaR-Trial: Platelets in Inflammation and Resolution.
- ClinicalTrials.gov ID
- NCT05098106
- Acronym / sponsor ID
- PLAIAR / 12-Anit-20
- Conditions
- ARDS, Platelet Abnormality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Collaborators
- Study Chair and Principal Investigator: Univ.-Prof. Dr. Alexander Zarbock, Principal Investigator: Dr. Andreas Margraf
- Study start
- 1 May 2021 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 28 Oct 2021 (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.
Detection and determination of platelets in bronchoalveolar lavage fluid and blood in ARDS and non-ARDS-patients. Correlation with phenotype and inflammation parameters in blood and outcome parameters.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pneumonia patients with ARDS | – | Diagnostic Test: Bronchoscopy, blood sampling; testing.Patients in the perioperative/intensive care setting with pneumonia-induced ARDS requiring bronchoscopy. |
| Ventilated patients without ARDS | – | Diagnostic Test: Bronchoscopy, blood sampling; testing.Patients without ARDS on mechanical ventilation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Perioperative patients
Key inclusion criteria (4 listed)
- Routine bronchoscopy
- Patient in perioperative setting
- Age >=18 years
- Consent
Key exclusion criteria (11 listed)
- Active or recent (in past 7 days) bleeding in upper airways
- Recent traumatic injury of the lung associated with (micro-)hemorrhage
- Blood aspiration
- Pregnancy
- Age<18 years
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 |
|---|---|---|
| Bronchoscopy, blood sampling; testing.BAL and blood samples are measured by hematology analyzer, flow cytometry, western blot, RNAseq analysis and multiplex. | Diagnostic test | Pneumonia patients with ARDS, Ventilated patients without ARDS |
Primary outcome
Detectability and changes in platelets in BAL and blood
Time frame: 5-7 days
Organ failure, survival.
Time frame: 1 Year
Systemic platelet and leukocyte numbers
Time frame: 5-7 days
Systemic platelet and leukocyte phenotypes.
Time frame: 5-7 days
Systemic cytokine profiles.
Time frame: 5-7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2021.
- 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.
Alexander Zarbock, Univ.-Prof. Dr. study chair
University Hospital Muenster
Andreas Margraf, Dr. principal investigator
University Hospital Muenster
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 ARDS and Platelet Abnormality, run by University Hospital Muenster at 1 site in Germany.
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 4 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 10 Nov 2021. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carola Wempe, Dr (+4925147255, wempe-c@anit.uni-muenster.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detectability and changes in platelets in BAL and blood (time frame: 5-7 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Nov 2021.