Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-02-25 @ 10:04 PM
Study NCT ID:
NCT03519594
Status:
COMPLETED
Last Update Posted:
2018-05-09
First Post:
2018-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Size of Pelvic Hematoma Can be a Predictive Factor for Angioembolization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-07', 'studyFirstSubmitDate': '2018-04-20', 'studyFirstSubmitQcDate': '2018-05-07', 'lastUpdatePostDateStruct': {'date': '2018-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Predictive factors for embolization in unstable pelvic fracture', 'timeFrame': '2 years', 'description': 'The factors affecting embolization are analyzed by logistic regression analysis'}], 'secondaryOutcomes': [{'measure': 'The odds ratio of mortality rate between two groups', 'timeFrame': '2 years', 'description': 'Obtain the difference in mortality rate between two groups'}, {'measure': 'Cut-off values of pelvic hematoma width', 'timeFrame': '2 years', 'description': 'Measure the length of pelvic hematoma using the ROC curve'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['angioembolization', 'computed tomography'], 'conditions': ['Multiple Pelvic Fractures']}, 'referencesModule': {'references': [{'pmid': '28115984', 'type': 'RESULT', 'citation': 'Coccolini F, Stahel PF, Montori G, Biffl W, Horer TM, Catena F, Kluger Y, Moore EE, Peitzman AB, Ivatury R, Coimbra R, Fraga GP, Pereira B, Rizoli S, Kirkpatrick A, Leppaniemi A, Manfredi R, Magnone S, Chiara O, Solaini L, Ceresoli M, Allievi N, Arvieux C, Velmahos G, Balogh Z, Naidoo N, Weber D, Abu-Zidan F, Sartelli M, Ansaloni L. Pelvic trauma: WSES classification and guidelines. World J Emerg Surg. 2017 Jan 18;12:5. doi: 10.1186/s13017-017-0117-6. eCollection 2017.'}, {'pmid': '28463936', 'type': 'RESULT', 'citation': 'Hymel A, Asturias S, Zhao F, Bliss R, Moran T, Marshall RH, Benjamin E, Phelan HA, Krause PC, Marecek GS, Leonardi C, Stuke L, Hunt JP, Mooney JL. Selective versus nonselective embolization versus no embolization in pelvic trauma: A multicenter retrospective cohort study. J Trauma Acute Care Surg. 2017 Sep;83(3):361-367. doi: 10.1097/TA.0000000000001554.'}, {'pmid': '18954776', 'type': 'RESULT', 'citation': 'Salim A, Teixeira PG, DuBose J, Ottochian M, Inaba K, Margulies DR, Demetriades D. Predictors of positive angiography in pelvic fractures: a prospective study. J Am Coll Surg. 2008 Nov;207(5):656-62. doi: 10.1016/j.jamcollsurg.2008.05.025. Epub 2008 Jul 14.'}, {'pmid': '16917449', 'type': 'RESULT', 'citation': 'Blackmore CC, Cummings P, Jurkovich GJ, Linnau KF, Hoffer EK, Rivara FP. Predicting major hemorrhage in patients with pelvic fracture. J Trauma. 2006 Aug;61(2):346-52. doi: 10.1097/01.ta.0000226151.88369.c9.'}]}, 'descriptionModule': {'briefSummary': 'Unstable pelvic fracture with bleeding can be fatal, with a mortality rate of up to 40%. Therefore, early detection and treatment are important in unstable pelvic trauma. We investigated the early predictive factors for possible embolization in patients with hemodynamically unstable pelvic trauma. The purpose of this study was to predict the necessity of embolization and the timing of angiography using CT scans.', 'detailedDescription': 'Background: Unstable pelvic fracture with bleeding can be fatal, with a mortality rate of up to 40%. Therefore, early detection and treatment are important in unstable pelvic trauma. We investigated the early predictive factors for possible embolization in patients with hemodynamically unstable pelvic trauma.\n\nMethods: From January 2011 to December 2013, 46 patients with shock arrived at a single hospital within 24 h after injury. Of them, 44 patients underwent computed tomography (CT) after initial resuscitation, except for 2 who were dead on arrival. Nine patients with other organ injuries were excluded. Seventeen patients underwent embolization. A single radiologist measured the width (longest length in axial view) and length (longest length in coronal view) of pelvic hematoma on CT scans. Demographic, clinical, and radiological data were reviewed retrospectively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients with major trauma and pelvic bone fracture', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with shock (systolic blood pressure \\<90 mmHg) arrived at a single hospital within 24 h after injury after pelvic fracture\n\nExclusion Criteria:\n\n* declared dead on arrival\n* patients with other organ injuries'}, 'identificationModule': {'nctId': 'NCT03519594', 'briefTitle': 'The Size of Pelvic Hematoma Can be a Predictive Factor for Angioembolization', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'The Size of Pelvic Hematoma Can be a Predictive Factor for Angioembolization in Hemodynamically Unstable Pelvic Trauma', 'orgStudyIdInfo': {'id': 'AsanMC-Hematoma'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Embolization group', 'description': 'The group that underwent embolization after pelvic injury.'}, {'label': 'Non-embolization group', 'description': 'The observed group of pelvic injuries without embolization'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Suk-kyung Hong, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asan Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Suk-Kyung', 'investigatorAffiliation': 'Asan Medical Center'}}}}