Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-03-06 @ 2:41 AM
Study NCT ID:
NCT00574002
Status:
WITHDRAWN
Last Update Posted:
2017-01-09
First Post:
2007-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Establishing Safe Drainage Limits for Pleural Chest Tube Removal.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Low study enrollment; re-evaluating study protocol and study selection criteria.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-05', 'studyFirstSubmitDate': '2007-12-12', 'studyFirstSubmitQcDate': '2007-12-12', 'lastUpdatePostDateStruct': {'date': '2017-01-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Repeat chest tube insertion within 30 days', 'timeFrame': 'two years'}, {'measure': 'Thoracotomy on affected side within 30 days', 'timeFrame': 'Two years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Thoracic Surgery', 'Thoracic Trauma']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate a safe threshold for when to remove chest tubes in patients based on the amount of drainage present.', 'detailedDescription': 'Measurement of pleural fluid drainage in chest tubes of trauma patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Surgery patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presence of at least one chest tube\n* No air leak present\n* Fluid is not infected\n* Pleural drainage of fluid was an indication for placement of the chest tube\n* Patient is post-thoracic surgery\n* Patient is post-thoracic trauma\n* Informed consent obtained\n\nExclusion Criteria:\n\n* Presence of air leak\n* Infected pleural fluid\n* Active intra-thoracic bleeding\n* Thoracic empyema\n* Non-removal of chest tube (i.e.: expired)\n* Pregnancy\n* Less than 18 years of age\n* Unable to obtain informed consent'}, 'identificationModule': {'nctId': 'NCT00574002', 'briefTitle': 'Establishing Safe Drainage Limits for Pleural Chest Tube Removal.', 'organization': {'class': 'OTHER', 'fullName': 'University of Missouri, Kansas City'}, 'officialTitle': 'Defining the Threshold for Safe Chest Tube Removal.', 'orgStudyIdInfo': {'id': '07-68e'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group A', 'description': 'Patients that have their chest tube removed when drainage is 400mL or less in 24 hours.'}, {'label': 'Group B.', 'description': 'Patients that have their chest tube removed when drainage is 200mL or less in 24 hours.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Truman Medical Center', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}], 'overallOfficials': [{'name': 'Gerald L. Early, M.D., M.A.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Truman Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Missouri, Kansas City', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}