Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-25 @ 7:57 PM
Study NCT ID:
NCT07016568
Status:
COMPLETED
Last Update Posted:
2025-10-17
First Post:
2025-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Temporary Aortic Occlusion With the Abdominal Tourniquet for Refractory Postpartum Haemorrhage: A Proof-of-Concept Study in a War-Affected Region
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006473', 'term': 'Postpartum Hemorrhage'}, {'id': 'D014593', 'term': 'Uterine Inertia'}], 'ancestors': [{'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011644', 'term': 'Puerperal Disorders'}, {'id': 'D014592', 'term': 'Uterine Hemorrhage'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D004420', 'term': 'Dystocia'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jenyapolyakova@gmail.com', 'phone': '+380502818399', 'title': 'Yevheniia Poliakova', 'organization': 'LLC UkrMedGroup'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': '* Small sample size prevents generalizability.\n* No control group.\n* Estimates of blood loss may be subject to observer bias.'}}, 'adverseEventsModule': {'timeFrame': 'From enrollment until end of follow-up, up to 12 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'AAJT-S Device Intervention Arm', 'description': 'Participants in this arm will receive standard postpartum hemorrhage (PPH) management followed by application of the Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) device if bleeding remains uncontrolled after uterotonics and uterine balloon tamponade. The device will be applied to the upper abdomen and inflated to 250 mmHg to achieve temporary aortic occlusion for up to 60 minutes. The intervention is intended to temporize bleeding while definitive surgical treatment and blood transfusion are arranged.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Bleeding Control After AAJT-S Device Application', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AAJT-S Device Intervention Arm', 'description': 'Participants in this arm will receive standard postpartum hemorrhage (PPH) management followed by application of the Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) device if bleeding remains uncontrolled after uterotonics and uterine balloon tamponade. The device will be applied to the upper abdomen and inflated to 250 mmHg to achieve temporary aortic occlusion for up to 60 minutes. The intervention is intended to temporize bleeding while definitive surgical treatment and blood transfusion are arranged.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'spread': '0.01', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Within 10 minutes of AAJT-S device application', 'description': 'Defined as the time (in minutes) from inflation of the AAJT-S device to visible cessation of external vaginal bleeding in patients with severe postpartum hemorrhage due to uterine atony. Bleeding control will be determined by visual clinical assessment by the attending provider. This measure evaluates the immediate effectiveness of the intervention in stopping hemorrhage and buying time for definitive surgical management or transfusion.', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Total Measured Blood Loss (Pre- and Post-intervention)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AAJT-S Device Intervention Arm', 'description': 'Participants in this arm will receive standard postpartum hemorrhage (PPH) management followed by application of the Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) device if bleeding remains uncontrolled after uterotonics and uterine balloon tamponade. The device will be applied to the upper abdomen and inflated to 250 mmHg to achieve temporary aortic occlusion for up to 60 minutes. The intervention is intended to temporize bleeding while definitive surgical treatment and blood transfusion are arranged.'}], 'classes': [{'categories': [{'measurements': [{'value': '1425', 'groupId': 'OG000', 'lowerLimit': '1150', 'upperLimit': '1800'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From onset of PPH until bleeding is definitively controlled (typically within 1-6 hours)', 'description': 'Sum of blood loss (in mL), measured by pad/towel weights after AAJT-S use until definitive hemostasis.', 'unitOfMeasure': 'ml', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Incidence of Device-related Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AAJT-S Device Intervention Arm', 'description': 'Participants in this arm will receive standard postpartum hemorrhage (PPH) management followed by application of the Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) device if bleeding remains uncontrolled after uterotonics and uterine balloon tamponade. The device will be applied to the upper abdomen and inflated to 250 mmHg to achieve temporary aortic occlusion for up to 60 minutes. The intervention is intended to temporize bleeding while definitive surgical treatment and blood transfusion are arranged.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From device application through hospital discharge (up to 7 days)', 'description': 'Includes thrombotic events, ischemic injury, skin necrosis, or technical malfunction during/after AAJT-S use.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hemodynamic Stabilization Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AAJT-S Device Intervention Arm', 'description': 'Participants in this arm will receive standard postpartum hemorrhage (PPH) management followed by application of the Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) device if bleeding remains uncontrolled after uterotonics and uterine balloon tamponade. The device will be applied to the upper abdomen and inflated to 250 mmHg to achieve temporary aortic occlusion for up to 60 minutes. The intervention is intended to temporize bleeding while definitive surgical treatment and blood transfusion are arranged.'}], 'classes': [{'categories': [{'measurements': [{'value': '31.25', 'spread': '6.29', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'First 60 minutes after AAJT-S application', 'description': 'Time from device inflation to achievement of target blood pressure (SBP ≥90 mmHg) and pulse \\<110 bpm.', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Long-term Maternal Recovery Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AAJT-S Device Intervention Arm', 'description': 'Participants in this arm will receive standard postpartum hemorrhage (PPH) management followed by application of the Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) device if bleeding remains uncontrolled after uterotonics and uterine balloon tamponade. The device will be applied to the upper abdomen and inflated to 250 mmHg to achieve temporary aortic occlusion for up to 60 minutes. The intervention is intended to temporize bleeding while definitive surgical treatment and blood transfusion are arranged.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 6 weeks postpartum', 'description': 'Assessed via follow-up calls and scheduled ultrasound visits at 6 weeks postpartum, including return to normal activity, presence of chronic pain, or menstrual abnormalities.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Experimental: AAJT-S Device Intervention Arm', 'description': 'Participants in this arm received standard postpartum hemorrhage (PPH) management followed by application of the Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) device if bleeding remains uncontrolled after uterotonics and uterine balloon tamponade. The device was applied to the upper abdomen and inflated to 250 mmHg to achieve temporary aortic occlusion for up to 60 minutes. The intervention was intended to temporize bleeding while definitive surgical treatment and blood transfusion are arranged.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited at Olexandrivska Hospital (Zaporizhzhia, Ukraine) between December 2024 and April 2025. Recruitment was based on clinical diagnosis of refractory postpartum hemorrhage due to uterine atony, and all participants provided oral informed consent.', 'preAssignmentDetails': 'All enrolled participants (N=4) met the eligibility criteria and were assigned to the intervention arm. No screening failures, exclusions, or withdrawals occurred prior to device application.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Experimental: AAJT-S Device Intervention Arm', 'description': 'Participants in this arm received standard postpartum hemorrhage (PPH) management followed by application of the Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) device if bleeding remains uncontrolled after uterotonics and uterine balloon tamponade. The device was applied to the upper abdomen and inflated to 250 mmHg to achieve temporary aortic occlusion for up to 60 minutes. The intervention was intended to temporize bleeding while definitive surgical treatment and blood transfusion are arranged.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Ukraine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Parity', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2.5', 'spread': '1.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Number of previous deliveries (including both vaginal and cesarean births) prior to the index pregnancy.', 'unitOfMeasure': 'Births', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Estimated Blood Loss Prior to AAJT-S Application', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1125', 'groupId': 'BG000', 'lowerLimit': '1030', 'upperLimit': '1200'}]}]}], 'paramType': 'MEAN', 'description': 'Volume of blood loss assessed by gravimetric methods before placement of the AAJT-S device.', 'unitOfMeasure': 'ml', 'dispersionType': 'FULL_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-11-01', 'size': 90676, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-07-30T16:14', 'hasProtocol': True}, {'date': '2024-11-01', 'size': 109659, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-07-30T16:14', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is a prospective, single-arm, open-label proof-of-concept study. All eligible participants will receive the investigational intervention (AAJT-S device) as an adjunct to standard care for severe postpartum hemorrhage unresponsive to uterotonics and balloon tamponade. No comparator or control group is included. The study is designed to evaluate feasibility, safety, and preliminary clinical outcomes in a conflict-affected, resource-limited setting.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-01', 'studyFirstSubmitDate': '2025-06-04', 'resultsFirstSubmitDate': '2025-07-30', 'studyFirstSubmitQcDate': '2025-06-04', 'lastUpdatePostDateStruct': {'date': '2025-10-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-10-01', 'studyFirstPostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Bleeding Control After AAJT-S Device Application', 'timeFrame': 'Within 10 minutes of AAJT-S device application', 'description': 'Defined as the time (in minutes) from inflation of the AAJT-S device to visible cessation of external vaginal bleeding in patients with severe postpartum hemorrhage due to uterine atony. Bleeding control will be determined by visual clinical assessment by the attending provider. This measure evaluates the immediate effectiveness of the intervention in stopping hemorrhage and buying time for definitive surgical management or transfusion.'}, {'measure': 'Total Measured Blood Loss (Pre- and Post-intervention)', 'timeFrame': 'From onset of PPH until bleeding is definitively controlled (typically within 1-6 hours)', 'description': 'Sum of blood loss (in mL), measured by pad/towel weights after AAJT-S use until definitive hemostasis.'}, {'measure': 'Incidence of Device-related Complications', 'timeFrame': 'From device application through hospital discharge (up to 7 days)', 'description': 'Includes thrombotic events, ischemic injury, skin necrosis, or technical malfunction during/after AAJT-S use.'}], 'secondaryOutcomes': [{'measure': 'Hemodynamic Stabilization Time', 'timeFrame': 'First 60 minutes after AAJT-S application', 'description': 'Time from device inflation to achievement of target blood pressure (SBP ≥90 mmHg) and pulse \\<110 bpm.'}, {'measure': 'Long-term Maternal Recovery Status', 'timeFrame': 'At 6 weeks postpartum', 'description': 'Assessed via follow-up calls and scheduled ultrasound visits at 6 weeks postpartum, including return to normal activity, presence of chronic pain, or menstrual abnormalities.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['uterine atony', 'postpartum haemorrhage', 'Emergency Obstetric Care', 'Aortic Compression'], 'conditions': ['Postpartum Haemorrhage (PPH)']}, 'referencesModule': {'references': [{'pmid': '21676082', 'type': 'BACKGROUND', 'citation': 'Soltan MH, Sadek RR. Experience managing postpartum hemorrhage at Minia University Maternity Hospital, Egypt: no mortality using external aortic compression. J Obstet Gynaecol Res. 2011 Nov;37(11):1557-63. doi: 10.1111/j.1447-0756.2011.01574.x. Epub 2011 Jun 16.'}, {'pmid': '19527382', 'type': 'BACKGROUND', 'citation': 'Soltan MH, Faragallah MF, Mosabah MH, Al-Adawy AR. External aortic compression device: the first aid for postpartum hemorrhage control. J Obstet Gynaecol Res. 2009 Jun;35(3):453-8. doi: 10.1111/j.1447-0756.2008.00975.x.'}, {'pmid': '30768561', 'type': 'BACKGROUND', 'citation': 'Kheirabadi BS, Dubick MA. Safe duration of Abdominal Aortic and Junctional Tourniquet application. J Trauma Acute Care Surg. 2019 Sep;87(3):740-741. doi: 10.1097/TA.0000000000002231. No abstract available.'}, {'pmid': '39304012', 'type': 'BACKGROUND', 'citation': 'Nieto-Calvache AJ, Palacios-Jaraquemada JM, Aryananda RA, Basanta N, Cininta N, Rivera-Torres LF, Bautista E, Hussein AM. External aortic compression: buying time to save lives in obstetric hemorrhage. Am J Obstet Gynecol. 2025 Feb;232(2):239-241. doi: 10.1016/j.ajog.2024.09.017. Epub 2024 Sep 18. No abstract available.'}, {'pmid': '7818062', 'type': 'BACKGROUND', 'citation': 'Riley DP, Burgess RW. External abdominal aortic compression: a study of a resuscitation manoeuvre for postpartum haemorrhage. Anaesth Intensive Care. 1994 Oct;22(5):571-5. doi: 10.1177/0310057X9402200512.'}, {'pmid': '35248574', 'type': 'BACKGROUND', 'citation': 'Nieto-Calvache AJ, Palacios Jaraquemada JM, Basanta N, Aryananda RA, Sinisterra-Diaz SE, Rodriguez F, Hidalgo Cardona A, Messa Bryon A. Internal manual compression of the aorta-an effective way to temporarily control pelvic bleeding in obstetrical hemorrhage. Am J Obstet Gynecol. 2022 Jul;227(1):96-97. doi: 10.1016/j.ajog.2022.02.040. Epub 2022 Mar 4.'}, {'pmid': '29626141', 'type': 'BACKGROUND', 'citation': 'Khan M, Jeyanathan J, Smith JE. Novel use for the abdominal tourniquet in the management of postpartum haemorrhage. J R Army Med Corps. 2018 Nov;164(6):463. doi: 10.1136/jramc-2018-000953. Epub 2018 Apr 6. No abstract available.'}], 'seeAlsoLinks': [{'url': 'https://www.narescue.com/abdominal-aortic-and-junctional-tourniquet-stablized-aajt-s.html', 'label': 'Information about The Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate whether a medical device called the Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) can safely and effectively temporarily stop severe bleeding after childbirth (known as postpartum hemorrhage) when standard treatments fail. The main question the study aims to answer is: Can the AAJT-S device temporarily control life-threatening postpartum bleeding long enough to allow doctors to prepare for surgery and other definitive treatment?', 'detailedDescription': 'This prospective, open-label, non-randomized, proof-of-concept study will assess the feasibility, safety, and preliminary clinical effectiveness of the Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) device as a temporizing measure for severe postpartum hemorrhage (PPH) due to uterine atony that is unresponsive to standard first-line therapies. The study will be conducted in a tertiary referral center in Zaporizhzhia, Ukraine, located in a conflict-affected region with limited access to timely surgical intervention and blood products.\n\nEligible participants will be adult postpartum patients (≥18 years) who develop primary PPH with blood loss exceeding 1,000 mL and who fail to respond to pharmacologic uterotonics and balloon tamponade. Patients with hemorrhage due to trauma, coagulopathy, or retained placental tissue will be excluded.\n\nOnce standard management protocols are exhausted and eligibility is confirmed, the AAJT-S device will be deployed over the upper abdomen and inflated to 250 mmHg to achieve temporary occlusion of the abdominal aorta and inferior vena cava. The device is intended to reduce pelvic blood flow and thereby control hemorrhage during the critical window required to mobilize a surgical team, arrange blood transfusion, and secure anesthesia.\n\nThe device will remain in place for a maximum of 60 minutes, consistent with published safety guidelines. Clinical endpoints will include time to bleeding control, hemodynamic stabilization, need for additional surgical intervention, and total blood loss. Safety endpoints will include thrombotic events, ischemic injury, infections, and any other adverse events related to device use.\n\nData will be collected prospectively, including demographic characteristics, obstetric history, timing and duration of interventions, and perioperative outcomes. Descriptive statistics will be used to summarize findings, with no formal hypothesis testing due to the pilot nature of the study.\n\nAll participants will receive routine inpatient follow-up, and longer-term outcomes will be assessed via scheduled in-person visits and structured telephone interviews at 6 and 12 months postpartum to evaluate for delayed complications and maternal recovery. The study is designed to generate preliminary data for further exploration of the AAJT-S device as a potential emergency tool for PPH management in resource-limited and crisis settings.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Self-identified females who are biologically capable of pregnancy and childbirth are eligible to participate. The study includes individuals assigned female at birth with a functioning uterus who have delivered vaginally and experienced postpartum hemorrhage. Participation is limited to those with physiologic ability to undergo the obstetric processes being studied.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years\n* Clinical diagnosis of postpartum hemorrhage (PPH) refractory to uterotonics and intrauterine balloon tamponade\n* Estimated blood loss greater than 1,000 mL\n* Oral informed consent provided prior to device application\n\nExclusion Criteria:\n\n* Patients with postpartum bleeding as a result of trauma, retained placenta or coagulopathy were excluded'}, 'identificationModule': {'nctId': 'NCT07016568', 'acronym': 'TAOAT', 'briefTitle': 'Temporary Aortic Occlusion With the Abdominal Tourniquet for Refractory Postpartum Haemorrhage: A Proof-of-Concept Study in a War-Affected Region', 'organization': {'class': 'INDUSTRY', 'fullName': 'LLC UkrMedGroup'}, 'officialTitle': 'Temporary Aortic Occlusion With the Abdominal Tourniquet for Refractory Postpartum Haemorrhage: A Proof-of-Concept Study in a War-Affected Region', 'orgStudyIdInfo': {'id': '2024/EC/128094'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AAJT-S Device Intervention Arm', 'description': 'Participants in this arm will receive standard postpartum hemorrhage (PPH) management followed by application of the Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) device if bleeding remains uncontrolled after uterotonics and uterine balloon tamponade. The device will be applied to the upper abdomen and inflated to 250 mmHg to achieve temporary aortic occlusion for up to 60 minutes. The intervention is intended to temporize bleeding while definitive surgical treatment and blood transfusion are arranged.', 'interventionNames': ['Device: Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)']}], 'interventions': [{'name': 'Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)', 'type': 'DEVICE', 'description': 'The AAJT-S is a non-invasive, externally applied medical device designed to achieve temporary occlusion of the abdominal aorta and inferior vena cava by inflating a pneumatic bladder to 250 mmHg. In this study, the device will be used as a temporizing measure for patients with severe postpartum hemorrhage unresponsive to standard uterotonics and balloon tamponade. The device will be applied horizontally over the upper abdomen and inflated using a built-in pressure gauge. The intended effect is to reduce pelvic blood flow and allow time for mobilization of surgical resources and blood transfusion. Maximum application time will not exceed 60 minutes, in accordance with established safety guidelines.', 'armGroupLabels': ['AAJT-S Device Intervention Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69000', 'city': 'Zaporizhzhia', 'country': 'Ukraine', 'facility': 'Olexandrivska Hospital', 'geoPoint': {'lat': 47.15214, 'lon': 35.74246}}], 'overallOfficials': [{'name': 'Viktor Oshovskyy, DMSc, PhD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'pirhospr@gmail.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data (IPD) will not be shared due to the small sample size and the sensitive nature of the clinical context, including emergency obstetric care in a war-affected setting. Additional ethical and regulatory considerations related to patient privacy and consent limit the possibility of external data sharing.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LLC UkrMedGroup', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}