PLAIAR-Trial: Platelets in Inflammation and Resolution

NCT05098106 | Unknown

• 1 other identifier: 12-Anit-20
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

ARDS; Platelet Abnormality

Outcome Measures

Primary Outcomes (5)

• Detectability and changes in platelets in BAL and blood

  5-7 days

• Organ failure, survival.

  1 Year

• Systemic platelet and leukocyte numbers

  5-7 days

• Systemic platelet and leukocyte phenotypes.

  5-7 days

• Systemic cytokine profiles.

  5-7 days

Study Arms (2)

Pneumonia patients with ARDS

Patients in the perioperative/intensive care setting with pneumonia-induced ARDS requiring bronchoscopy.

Diagnostic Test: Bronchoscopy, blood sampling; testing.

Ventilated patients without ARDS

Patients without ARDS on mechanical ventilation.

Diagnostic Test: Bronchoscopy, blood sampling; testing.

Interventions

Bronchoscopy, blood sampling; testing. DIAGNOSTIC_TEST

BAL and blood samples are measured by hematology analyzer, flow cytometry, western blot, RNAseq analysis and multiplex.

Pneumonia patients with ARDS; Ventilated patients without ARDS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Perioperative patients

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Muenster: lead
• Study Chair and Principal Investigator: Univ.-Prof. Dr. Alexander Zarbock: collaborator
• Principal Investigator: Dr. Andreas Margraf: collaborator

Study Sites (1)

University Hospital Muenster

Münster, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Bronchoalveolar lavage fluid, blood.

MeSH Terms

Conditions

Blood Platelet Disorders

Interventions

Bronchoscopy; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures; Specimen Handling; Clinical Laboratory Techniques; Punctures; Investigative Techniques

Study Officials

• Alexander Zarbock, Univ.-Prof. Dr.

  University Hospital Muenster

  STUDY CHAIR

• Andreas Margraf, Dr.

  University Hospital Muenster

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carola Wempe, Dr

CONTACT

+4925147255; wempe-c@anit.uni-muenster.de

Andreas Margraf, Dr

CONTACT

+492518346843; andreas.margraf@anit.uni-muenster.de

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2021
• First Posted: October 28, 2021
• Study Start: May 1, 2021
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: November 10, 2021

Record last verified: 2021-10

Locations

DE (1)