Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:46 AM
Study NCT ID:
NCT07492758
Status:
COMPLETED
Last Update Posted:
2026-03-25
First Post:
2024-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Management of Extremity Injuries Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012042', 'term': 'Registries'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D011996', 'term': 'Records'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 999}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-19', 'studyFirstSubmitDate': '2024-11-14', 'studyFirstSubmitQcDate': '2026-03-19', 'lastUpdatePostDateStruct': {'date': '2026-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'establish a data set that will be permissive of quality improvement studies/observations specific to life and limb salvage in comprisable extremity injuries.', 'timeFrame': 'through study completion, up to 18 months', 'description': 'Trauma Registry will be queried for demographic information, admission dates, traumatic injury characteristics, inpatient outcomes, complications, consultations, resuscitation strategies, compression time to control bleeding, use of tourniquet and indications, discharge location, and mortality. Additional triage assessments, bleeding management, and in-patient timeline, will be abstracted from EPIC.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Trauma']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to establish a data set that will be permissive of quality improvement studies/observations specific to life and limb salvage in comprisable extremity injuries.', 'detailedDescription': 'Tourniquets are often overused. Direct pressure should be the first step in STB. Combat dressings allow for hands free pressure. These data could provide a foundation for pre-hospital process improvement studies.\n\nThis data repository will serve as a means to aggregate and analyze best practices related to trauma patients with extremity injuries. Specific interest will be placed in best practices of the emergency medical service and trauma bay, use of tourniquets and compression bandages, ischemic injuries, and limb salvage.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult trauma patients; defined by the American College of Surgeons as individuals age: ≥16 years, identified in the MDMC trauma registry with documented extremity injury.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult trauma patients; defined by the American College of Surgeons as individuals age: ≥16 years\n* Included in the MDMC trauma registry\n* Documented extremity injury\n\nExclusion Criteria:\n\n* \\<16 years old'}, 'identificationModule': {'nctId': 'NCT07492758', 'briefTitle': 'Management of Extremity Injuries Registry', 'organization': {'class': 'OTHER', 'fullName': 'Methodist Health System'}, 'officialTitle': 'Management of Extremity Injuries Registry', 'orgStudyIdInfo': {'id': '039.TRA.2023.D'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Non-Interventional (Registry)', 'type': 'OTHER', 'description': 'Non-Interventional (Registry)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75203', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Clinical Research Institute at Methodist Health System', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Conner McDaniel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Methodist Heath System'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Methodist Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}