Ignite Creation Date:
2025-12-24 @ 12:13 PM
Ignite Modification Date:
2026-01-14 @ 9:01 PM
Study NCT ID:
NCT01965561
Status:
COMPLETED
Last Update Posted:
2017-12-13
First Post:
2013-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Performance of Junctional Tourniquets in Normal Human Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'john.f.kragh.civ@mail.mil', 'phone': '210.539.2210', 'title': 'John Kragh, MD', 'organization': 'USAISR'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Junctional Tourniquet Use', 'description': 'Junctional tourniquet use followed by rest, repeat.', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Effectiveness at Stopping Distal Pulse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'CRoC', 'description': 'Use of Combat Ready Clamp (CRoC)'}, {'id': 'OG001', 'title': 'AAJT', 'description': 'Use of Abdominal Aortic and Junctional Tourniquet (AAJT)'}, {'id': 'OG002', 'title': 'JETT', 'description': 'Use of Junctional Emergency Treatment Tool (JETT)'}, {'id': 'OG003', 'title': 'SJT Tourniquet', 'description': 'SAM Junctional Tourniquet (SJT)'}], 'classes': [{'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 min', 'description': 'Percentage of participants whose distal pulse ceased within 1 minute of junctional tourniquet application.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain During Tourniquet Application', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'CRoC', 'description': 'Use of Combat Ready Clamp (CRoC)'}, {'id': 'OG001', 'title': 'AAJT', 'description': 'Use of Abdominal Aortic and Junctional Tourniquet (AAJT)'}, {'id': 'OG002', 'title': 'JETT', 'description': 'Use of Junctional Emergency Treatment Tool (JETT)'}, {'id': 'OG003', 'title': 'SJT Tourniquet', 'description': 'SAM Junctional Tourniquet (SJT)'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'spread': '23', 'groupId': 'OG000'}, {'value': '76', 'spread': '14', 'groupId': 'OG001'}, {'value': '45', 'spread': '40', 'groupId': 'OG002'}, {'value': '43', 'spread': '31', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 minute', 'description': 'Pain during tourniquet application as measured on a visual analog scale (VAS). The pain scale was a 100-mm-long line on a piece of paper. The subject made a cross mark on the line, which went from the left limit (0 mm) at no pain to the right limit (100 mm) at very severe pain.', 'unitOfMeasure': 'mm on VAS', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Junctional Tourniquet Use', 'description': 'Junctional tourniquet use followed by rest, repeat. Rest = 5 minutes. SJT is belt with discs that inflate. JETT is belt with pads that screw down. AAT is a bladder within a belt. CRC is a vice.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Junctional Tourniquet Use', 'description': 'Junctional tourniquet use followed by rest, repeat\n\nRest = 5 minutes. SJT is belt with discs that inflate. JETT is belt with pads that screw down. AAT is an bladder within a belt. CRC is a vice.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000', 'lowerLimit': '42', 'upperLimit': '60'}]}]}], 'paramType': 'MEAN', 'description': 'Age of healthy human volunteers', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Pain', 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'MEAN', 'description': 'Pain level on Visual Analog Scale (0 mm = no pain, 100 mm = maximum pain)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'FULL_RANGE'}], 'populationDescription': 'Healthy human volunteers'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-14', 'studyFirstSubmitDate': '2013-10-15', 'resultsFirstSubmitDate': '2015-09-01', 'studyFirstSubmitQcDate': '2013-10-15', 'lastUpdatePostDateStruct': {'date': '2017-12-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-09-01', 'studyFirstPostDateStruct': {'date': '2013-10-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effectiveness at Stopping Distal Pulse', 'timeFrame': '1 min', 'description': 'Percentage of participants whose distal pulse ceased within 1 minute of junctional tourniquet application.'}], 'secondaryOutcomes': [{'measure': 'Pain During Tourniquet Application', 'timeFrame': '1 minute', 'description': 'Pain during tourniquet application as measured on a visual analog scale (VAS). The pain scale was a 100-mm-long line on a piece of paper. The subject made a cross mark on the line, which went from the left limit (0 mm) at no pain to the right limit (100 mm) at very severe pain.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hemorrhage']}, 'descriptionModule': {'briefSummary': 'Normal human adult volunteers wereused to investigate the performance of medical devices intended to stop junctional bleeding on the battlefield.', 'detailedDescription': 'Four FDA-cleared junctional tourniquets (Combat Ready Clamp (CRoC), Abdominal Aortic and Junctional Tourniquet (AAJT), Junctional Emergency Treatment Tool (JETT), and SAM Junctional Tourniquet (SJT)) wereassessed in a laboratory on healthy human volunteers. Lower extremity pulses were measured in 10 volunteers before and after junctional tourniquet application aimed at stopping the distal pulse assessed by Doppler auscultation. Tourniquets were applied in a randomized fashion, with 5 min rest periods between each application. Each tourniquet was applied to each subject, such that the subjects acted as their own controls.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult human volunteers who are recruited, screened, and consent to participate\n* Ages at least 18 years old to no more than 60 years old (\\<61) on the date of consent\n* Male or female\n* A worker for the US Military or US Government (active duty military, civilian employees, contractors)\n\nExclusion Criteria:\n\n* Active-duty military subjects without their supervisor's permission to participate\n* Detainees or prisoners\n* Evidence of major disease of an artery (e.g., artery or vein surgery, atherosclerotic disease diagnosis, stroke, peripheral vascular disease or dysfunction such as Reynaud's phenomenon, migraine headaches, or cardiovascular disease \\[uncontrolled hypertension, heart attack, or arrhythmias\\]), active abdominal, inguinal, gluteal, or thigh disease, major deformity, or hernias\n* Pregnancy\n* Contracted employees to the US Military or US Government without contractual permission to participate in the research"}, 'identificationModule': {'nctId': 'NCT01965561', 'briefTitle': 'Performance of Junctional Tourniquets in Normal Human Volunteers', 'organization': {'class': 'FED', 'fullName': 'United States Army Institute of Surgical Research'}, 'officialTitle': 'Performance of Junctional Tourniquets in Normal Human Volunteers', 'orgStudyIdInfo': {'id': 'H-13-016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CRoC', 'description': 'Use of Combat Ready Clamp (CRoC)', 'interventionNames': ['Device: CRoC']}, {'type': 'EXPERIMENTAL', 'label': 'AAJT', 'description': 'Use of Abdominal Aortic and Junctional Tourniquet', 'interventionNames': ['Device: AAJT']}, {'type': 'EXPERIMENTAL', 'label': 'JETT', 'description': 'Junctional Emergency Treatment Tool', 'interventionNames': ['Device: JETT']}, {'type': 'EXPERIMENTAL', 'label': 'SJT', 'description': 'SAM Junctional Tourniquet', 'interventionNames': ['Device: SJT']}], 'interventions': [{'name': 'CRoC', 'type': 'DEVICE', 'description': 'Use of Combat Ready Clamp (CRoC)', 'armGroupLabels': ['CRoC']}, {'name': 'AAJT', 'type': 'DEVICE', 'description': 'Use of Abdominal Aortic and Junctional Tourniquet (AAJT)', 'armGroupLabels': ['AAJT']}, {'name': 'JETT', 'type': 'DEVICE', 'description': 'Use of Junctional Emergency Treatment Tool (JETT)', 'armGroupLabels': ['JETT']}, {'name': 'SJT', 'type': 'DEVICE', 'description': 'Use of SAM Junctional Tourniquet (SJT)', 'armGroupLabels': ['SJT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78234-7767', 'city': 'Forts Sam Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'United States Army Institute of Surgical Research'}], 'overallOfficials': [{'name': 'John F Kragh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'United States Army Institute of Surgical Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'United States Army Institute of Surgical Research', 'class': 'FED'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Orthopedic Surgeon, Researcher', 'investigatorFullName': 'John F. Kragh, Jr, MD', 'investigatorAffiliation': 'United States Army Institute of Surgical Research'}}}}