Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2026-03-09 @ 2:35 AM
Study NCT ID:
NCT02855060
Status:
COMPLETED
Last Update Posted:
2022-04-21
First Post:
2016-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pre-hospital Advanced Therapies for Control of Hemorrhage - Pelvis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D006620', 'term': 'Hip Fractures'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rachel.seymour@atriumhealth.org', 'phone': '74-355-6969', 'title': 'Rachel Seymour', 'organization': 'Atrium Health'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '30 day', 'description': 'Medical record was reviewed for all patients after 30 days', 'eventGroups': [{'id': 'EG000', 'title': 'Pelvic Binder', 'description': 'Commercially available device used to stabilize the pelvis\n\nPelvic Binder', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'No Binder', 'description': 'Standard of care', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 0, 'seriousNumAtRisk': 28, 'deathsNumAffected': 2, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mortality Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pelvic Binder', 'description': 'Commercially available device used to stabilize the pelvis\n\nPelvic Binder'}, {'id': 'OG001', 'title': 'No Binder', 'description': 'Standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 day', 'description': 'Percentage of patients that experience mortality within 30 days of presentation will be compared between the two study arms', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Scores - Visual Analog Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pelvic Binder', 'description': 'Commercially available device used to stabilize the pelvis\n\nPelvic Binder'}, {'id': 'OG001', 'title': 'No Binder', 'description': 'Standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '8.5', 'groupId': 'OG000', 'lowerLimit': '7.5', 'upperLimit': '10'}, {'value': '10.0', 'groupId': 'OG001', 'lowerLimit': '7.0', 'upperLimit': '10.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At time of arrival to Emergency Department', 'description': 'Pain scores at presentation to hospital will be compared between the two study arms. Range 0-10. Higher scores indicate a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pain scores were not documented in the Emergency Department for all patients. Only patients with scores documented were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Skin Complications After Pelvic Binder Application', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pelvic Binder', 'description': 'Commercially available device used to stabilize the pelvis\n\nPelvic Binder'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From date of randomization to date of discharge or date of death from any cause, whichever came first, assessed up to 1 year', 'description': 'The rate of occurrence of skin complications after binder application will be documented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Stay in Hospital', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pelvic Binder', 'description': 'Commercially available device used to stabilize the pelvis\n\nPelvic Binder'}, {'id': 'OG001', 'title': 'No Binder', 'description': 'Standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '7.5', 'groupId': 'OG001', 'lowerLimit': '2.5', 'upperLimit': '16.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of admission to date of discharge or date of death from any cause, whichever came first, assessed up to 1 year', 'description': 'The total number of days the patient spent in the hospital', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Blood Transfusions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pelvic Binder', 'description': 'Commercially available device used to stabilize the pelvis\n\nPelvic Binder'}, {'id': 'OG001', 'title': 'No Binder', 'description': 'Standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48 hours', 'description': 'Number of Blood Transfusions within the first 48 hours after hospital admission', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pelvic Binder', 'description': 'Commercially available device used to stabilize the pelvis\n\nPelvic Binder'}, {'id': 'FG001', 'title': 'No Binder', 'description': 'Standard of care'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pelvic Binder', 'description': 'Commercially available device used to stabilize the pelvis\n\nPelvic Binder'}, {'id': 'BG001', 'title': 'No Binder', 'description': 'Standard of care'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '33.5', 'groupId': 'BG000', 'lowerLimit': '27.0', 'upperLimit': '45.0'}, {'value': '36.0', 'groupId': 'BG001', 'lowerLimit': '24.0', 'upperLimit': '49.0'}, {'value': '36.0', 'groupId': 'BG002', 'lowerLimit': '26.0', 'upperLimit': '47.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-12-20', 'size': 259329, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-01-07T09:35', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-19', 'studyFirstSubmitDate': '2016-07-27', 'resultsFirstSubmitDate': '2020-01-07', 'studyFirstSubmitQcDate': '2016-08-01', 'lastUpdatePostDateStruct': {'date': '2022-04-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-07-30', 'studyFirstPostDateStruct': {'date': '2016-08-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality Rate', 'timeFrame': '30 day', 'description': 'Percentage of patients that experience mortality within 30 days of presentation will be compared between the two study arms'}], 'secondaryOutcomes': [{'measure': 'Pain Scores - Visual Analog Scale', 'timeFrame': 'At time of arrival to Emergency Department', 'description': 'Pain scores at presentation to hospital will be compared between the two study arms. Range 0-10. Higher scores indicate a worse outcome.'}, {'measure': 'Number of Participants With Skin Complications After Pelvic Binder Application', 'timeFrame': 'From date of randomization to date of discharge or date of death from any cause, whichever came first, assessed up to 1 year', 'description': 'The rate of occurrence of skin complications after binder application will be documented.'}, {'measure': 'Length of Stay in Hospital', 'timeFrame': 'From date of admission to date of discharge or date of death from any cause, whichever came first, assessed up to 1 year', 'description': 'The total number of days the patient spent in the hospital'}, {'measure': 'Number of Patients With Blood Transfusions', 'timeFrame': '48 hours', 'description': 'Number of Blood Transfusions within the first 48 hours after hospital admission'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hemorrhage', 'Pelvic Fracture']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether the use of pelvic binders in the ambulance setting improves outcomes including mortality in patients with pelvic fractures.', 'detailedDescription': "The goal of this prospective, randomized clinical trial is to determine whether prehospital use of a commercial pelvic binder will improve morbidity and mortality in patients with pelvic fractures. We hypothesize that prehospital placement of pelvic binders will reduce hemorrhage and need for resuscitation and will improve overall mortality in patients with pelvic fractures. In addition, we hypothesize that pelvic splinting via external compression will improve patients' pain regardless of whether they have a pelvic, acetabular, or proximal femur fracture."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Traumatic injury other than ground-level fall, and\n* Complaint of pelvic groin or hip pain, or\n* Pelvic or hip deformity, ecchymosis, or crepitus in an obtunded patient, or\n* Hemodynamic instability\n\nExclusion Criteria:\n\n* Ground level fall\n* Penetrating pelvis injury without frank evidence of fracture\n* Obviously pregnant patients\n* Patients who are too small or too big for the binder\n* Priority 2 or 3 Trauma'}, 'identificationModule': {'nctId': 'NCT02855060', 'acronym': 'PATCH', 'briefTitle': 'Pre-hospital Advanced Therapies for Control of Hemorrhage - Pelvis', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Pre-hospital Advanced Therapies for Control of Hemorrhage (PATCH) - Pelvis', 'orgStudyIdInfo': {'id': '01-15-08B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pelvic Binder', 'description': 'Commercially available device used to stabilize the pelvis', 'interventionNames': ['Device: Pelvic Binder']}, {'type': 'NO_INTERVENTION', 'label': 'No Binder', 'description': 'Standard of care'}], 'interventions': [{'name': 'Pelvic Binder', 'type': 'DEVICE', 'armGroupLabels': ['Pelvic Binder']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28203', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolinas Medical Center', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}], 'overallOfficials': [{'name': 'Joseph R Hsu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}