Ignite Creation Date:
2025-12-24 @ 5:51 PM
Ignite Modification Date:
2026-01-02 @ 5:42 AM
Study NCT ID:
NCT03977168
Status:
UNKNOWN
Last Update Posted:
2022-08-30
First Post:
2019-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Study of Early Mechanical Stabilization and Bleeding in Disruption of the Pelvic Ring
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006620', 'term': 'Hip Fractures'}], 'ancestors': [{'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C015101', 'term': "cytidylyl-(3'-5')-cytidine"}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2019-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-29', 'studyFirstSubmitDate': '2019-06-04', 'studyFirstSubmitQcDate': '2019-06-04', 'lastUpdatePostDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Mortality', 'timeFrame': '1 month', 'description': 'Any deaths that occur between index hospitalization and 30 days post-injury will be documented'}], 'primaryOutcomes': [{'measure': 'Blood products', 'timeFrame': '24 hours', 'description': 'We will document the volume of any blood products given within the first 24 hours following injury'}, {'measure': 'Pelvic stabilization and resuscitative techniques', 'timeFrame': '24 hours', 'description': 'We will document any techniques used to stabilize and/or resuscitate the pelvic injury within the first 24 hours'}], 'secondaryOutcomes': [{'measure': 'Blood loss', 'timeFrame': '24 hours', 'description': 'Total blood volume loss will be calculated within the first 24 hours following injury'}, {'measure': 'Ventilator days', 'timeFrame': '24 hours', 'description': 'Number of days that patient spends on a ventilator will be documented'}, {'measure': 'ICU days', 'timeFrame': '24 hours', 'description': 'Number of days spent in the ICU will be documented'}, {'measure': 'Length of hospital stay', 'timeFrame': '24 hours', 'description': 'Number of days spent in the hospital will be documented'}, {'measure': 'GCS (Glascow Coma Score)', 'timeFrame': '24 hours', 'description': 'The GCS is a neurological scale to assess for brain injury. The score is composed of three parts: eyes, verbal and motor. Each component has a different scale. Eyes (1-4), verbal (1-5) and motor (1-6). The sum of all three components result in the overall GCS score (3-15). The higher the score, the less likelihood of brain injury'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pelvic Fracture']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the effect of earlier placement of Circumferential Pelvic Compression (CPC) on resuscitative measures required for life-threatening pelvic ring injuries and to guide the development of future efficacy trials of three advanced resuscitation techniques (surgical pelvic packing, angioembolization, REBOA).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with severe pelvic ring disruptions', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient age between 18 and 64 years, inclusive;\n* Severe blunt or blast traumatic injury;\n* Young-Burgess APC-2 and 3, LC-3, vertical shear, and combined mechanism of injury (CMI) (Tile B and C patterns; OTA codes 61-B and 61-C);\n* Circumferential pelvic compression (CPC) device used at any time within 24 hours of injury.\n* Patient must speak either English or Spanish\n\nExclusion Criteria:\n\n* Arrival to hospital of definitive care more than 6 hours after injury;\n* Ballistic pelvic injury, other than from a blast mechanism;\n* Time of CPC placement not recorded;\n* Time of injury and time of EMS dispatch unknown;\n* Use of medical anti-shock trousers (MAST);\n* Confirmed dead on arrival to hospital'}, 'identificationModule': {'nctId': 'NCT03977168', 'acronym': 'EMS-BIND', 'briefTitle': 'A Prospective Study of Early Mechanical Stabilization and Bleeding in Disruption of the Pelvic Ring', 'organization': {'class': 'OTHER', 'fullName': 'Major Extremity Trauma Research Consortium'}, 'officialTitle': 'A Prospective Study of Early Mechanical Stabilization and Bleeding in Disruption of the Pelvic Ring', 'orgStudyIdInfo': {'id': 'W81XWH-16-2-0060-EMS-BIND'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Application of circumferential pelvic compression (CPC) device', 'type': 'PROCEDURE', 'description': 'Application of circumferential pelvic compression (CPC) device used at any time within 24 hours of injury'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami Ryder Trauma Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Methodist Hospital', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland R Adams Cowley Shock Trauma Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55415', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Hennepin County Medical Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '28203', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolinas Medical Center', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest Baptist Medical Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Science Center - Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78234', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'San Antonio Military Medical Center (SAMMC)', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington/Harborview Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Major Extremity Trauma Research Consortium', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}