Ignite Creation Date:
2025-12-26 @ 2:43 PM
Ignite Modification Date:
2025-12-26 @ 2:43 PM
Study NCT ID:
NCT05098106
Status:
UNKNOWN
Last Update Posted:
2021-11-10
First Post:
2021-10-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PLAIAR-Trial: Platelets in Inflammation and Resolution
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001791', 'term': 'Blood Platelet Disorders'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001999', 'term': 'Bronchoscopy'}, {'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013510', 'term': 'Pulmonary Surgical Procedures'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Bronchoalveolar lavage fluid, blood.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-02', 'studyFirstSubmitDate': '2021-10-18', 'studyFirstSubmitQcDate': '2021-10-18', 'lastUpdatePostDateStruct': {'date': '2021-11-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detectability and changes in platelets in BAL and blood', 'timeFrame': '5-7 days'}, {'measure': 'Organ failure, survival.', 'timeFrame': '1 Year'}, {'measure': 'Systemic platelet and leukocyte numbers', 'timeFrame': '5-7 days'}, {'measure': 'Systemic platelet and leukocyte phenotypes.', 'timeFrame': '5-7 days'}, {'measure': 'Systemic cytokine profiles.', 'timeFrame': '5-7 days'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ARDS', 'Platelet Abnormality']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Perioperative patients', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Routine bronchoscopy\n* Patient in perioperative setting\n* Age \\>=18 years\n* Consent\n\nExclusion Criteria:\n\n* Active or recent (in past 7 days) bleeding in upper airways\n* Recent traumatic injury of the lung associated with (micro-)hemorrhage\n* Blood aspiration\n* Pregnancy\n* Age\\<18 years\n* Acute kidney injury / Chronic kidney failure / Dialysis\n* Transplantation\n* HIV\n* Hematologic diseases\n* Immunosuppression\n* Anti-Platelet-Therapy'}, 'identificationModule': {'nctId': 'NCT05098106', 'acronym': 'PLAIAR', 'briefTitle': 'PLAIAR-Trial: Platelets in Inflammation and Resolution', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Muenster'}, 'officialTitle': 'PlaIaR-Trial: Platelets in Inflammation and Resolution.', 'orgStudyIdInfo': {'id': '12-Anit-20'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pneumonia patients with ARDS', 'description': 'Patients in the perioperative/intensive care setting with pneumonia-induced ARDS requiring bronchoscopy.', 'interventionNames': ['Diagnostic Test: Bronchoscopy, blood sampling; testing.']}, {'label': 'Ventilated patients without ARDS', 'description': 'Patients without ARDS on mechanical ventilation.', 'interventionNames': ['Diagnostic Test: Bronchoscopy, blood sampling; testing.']}], 'interventions': [{'name': 'Bronchoscopy, blood sampling; testing.', 'type': 'DIAGNOSTIC_TEST', 'description': 'BAL and blood samples are measured by hematology analyzer, flow cytometry, western blot, RNAseq analysis and multiplex.', 'armGroupLabels': ['Pneumonia patients with ARDS', 'Ventilated patients without ARDS']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Münster', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Carola Wempe, Dr.', 'role': 'CONTACT', 'email': 'wempe-c@anit.uni-muenster.de', 'phone': '+4925147255'}, {'name': 'Andreas Margraf, Dr.', 'role': 'CONTACT', 'email': 'andreas.margraf@anit.uni-muenster.de'}], 'facility': 'University Hospital Muenster', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}], 'centralContacts': [{'name': 'Carola Wempe, Dr', 'role': 'CONTACT', 'email': 'wempe-c@anit.uni-muenster.de', 'phone': '+4925147255'}, {'name': 'Andreas Margraf, Dr', 'role': 'CONTACT', 'email': 'andreas.margraf@anit.uni-muenster.de', 'phone': '+492518346843'}], 'overallOfficials': [{'name': 'Alexander Zarbock, Univ.-Prof. Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital Muenster'}, {'name': 'Andreas Margraf, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Muenster'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Muenster', 'class': 'OTHER'}, 'collaborators': [{'name': 'Study Chair and Principal Investigator: Univ.-Prof. Dr. Alexander Zarbock', 'class': 'UNKNOWN'}, {'name': 'Principal Investigator: Dr. Andreas Margraf', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}