Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2025-12-29 @ 1:52 PM
Study NCT ID:
NCT07274150
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-10
First Post:
2025-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Abdominal Aortic Junction Tourniquet (AAJT-S) for Non-compressible Torso Haemorrhage in the Prehospital and Emergency Room Setting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009104', 'term': 'Multiple Trauma'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2028-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-27', 'studyFirstSubmitDate': '2025-11-18', 'studyFirstSubmitQcDate': '2025-11-27', 'lastUpdatePostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'effective placement of the device', 'timeFrame': '1 hour', 'description': 'cessation of bloodflow distal to the device'}], 'secondaryOutcomes': [{'measure': 'Outcome Measure', 'timeFrame': '30 days', 'description': '30-day in hospital mortality'}, {'measure': 'Complications', 'timeFrame': '90 days', 'description': 'Occurrence of complications of device application'}, {'measure': 'hemodynamic improvement after application', 'timeFrame': '1 hour', 'description': 'lower hart rate / higher blood pressure (improvement in bpm/mmHg)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NCTH', 'Exanguination', 'Aortic occlusion'], 'conditions': ['Exanguination', 'Polytrauma', 'NCTH']}, 'descriptionModule': {'briefSummary': 'This study seeks to evaluate the feasibility of a Abdominal Aortic Balloon Occlusion of the Aorta (AAJT-S) in exanguinating trauma patients with non-compressible truncal haemorrhage in the emergency room and the pre-hospital setting.', 'detailedDescription': 'Much like REBOA, AAJT-S can potentially stop blood flow distal to the device and therefore improve proximal aortic perfusion, minimize haemorrhage and stabilize patients until definite surgical repair/bleeding control is feasible. In contrast to REBOA, there is no need of femoral access and therefore, appropriate training is easily achieved.\n\nThis study seeks to gather further information on the benefits and potential harms of this intervention on a multicentre level.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '1. Suspected additional bleeding source proximal to the umbilicus\n2. Known or suspected pregnancy at presentation\n3. Known abdominal aortic aneurysm', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Written consent of the participant after being informed\n2. Aged, or believed to be aged, 18 years or above\n3. Confirmed or suspected life-threatening lower body trauma (i.e. signs of inadequate perfusion of tissues, tachycardia, hypotension, suspected blood loss)\n4. Thought to benefit from trauma resuscitation with AAJT-S or REBOA zone III\n5. Traumatic cardiac arrest\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT07274150', 'briefTitle': 'Abdominal Aortic Junction Tourniquet (AAJT-S) for Non-compressible Torso Haemorrhage in the Prehospital and Emergency Room Setting', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Graz'}, 'officialTitle': 'Abdominal Aortic Junction Tourniquet (AAJT-S) for Non-compressible Torso Haemorrhage A Prospective Multicentre-study', 'orgStudyIdInfo': {'id': '1331/2025'}}, 'contactsLocationsModule': {'locations': [{'zip': '8010', 'city': 'Graz', 'state': 'Styria', 'country': 'Austria', 'contacts': [{'name': 'Gabriel Honnef, MD, PhD', 'role': 'CONTACT', 'email': 'gabriel.honnef@medunigraz.at', 'phone': '06509160890'}, {'role': 'CONTACT', 'email': 'ghonnef@gmail.com'}, {'name': 'Gabriel Honnef, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Philipp Zoidl, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Paul Puchwein, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Medical University of Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}], 'centralContacts': [{'name': 'Gabriel Honnef, MD, PhD', 'role': 'CONTACT', 'email': 'gabriel.honnef@medunigraz.at', 'phone': '+436509160890'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Graz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}