PLAIAR-Trial: Platelets in Inflammation and Resolution (PLAIAR)

November 2, 2021 updated by: University Hospital Muenster

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

72

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Perioperative patients

Description

Inclusion Criteria:

  • Routine bronchoscopy
  • Patient in perioperative setting
  • Age >=18 years
  • Consent

Exclusion Criteria:

  • 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
  • Transplantation
  • HIV
  • Hematologic diseases
  • Immunosuppression
  • Anti-Platelet-Therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pneumonia patients with ARDS
Patients in the perioperative/intensive care setting with pneumonia-induced ARDS requiring bronchoscopy.
Diagnostic test: Bronchoscopy, blood sampling; testing.
BAL and blood samples are measured by hematology analyzer, flow cytometry, western blot, RNAseq analysis and multiplex.
Ventilated patients without ARDS
Patients without ARDS on mechanical ventilation.
Diagnostic test: Bronchoscopy, blood sampling; testing.
BAL and blood samples are measured by hematology analyzer, flow cytometry, western blot, RNAseq analysis and multiplex.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Detectability and changes in platelets in BAL and blood
Time Frame: 5-7 days
5-7 days
Organ failure, survival.
Time Frame: 1 Year
1 Year
Systemic platelet and leukocyte numbers
Time Frame: 5-7 days
5-7 days
Systemic platelet and leukocyte phenotypes.
Time Frame: 5-7 days
5-7 days
Systemic cytokine profiles.
Time Frame: 5-7 days
5-7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Muenster

Collaborators

Study Chair and Principal Investigator: Univ.-Prof. Dr. Alexander Zarbock
Principal Investigator: Dr. Andreas Margraf

Investigators

  • Study Chair: Alexander Zarbock, Univ.-Prof. Dr., University hospital Muenster
  • Principal Investigator: Andreas Margraf, Dr., University hospital Muenster

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2021

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

October 18, 2021

First Submitted That Met QC Criteria

October 18, 2021

First Posted (Actual)

October 28, 2021

Study Record Updates

Last Update Posted (Actual)

November 10, 2021

Last Update Submitted That Met QC Criteria

November 2, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-Anit-20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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