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This multicenter study aims to evaluate effectiveness and safety of using the AAJT-S device as a temporary intervention for severe, atony-related PPH that is refractory to standard therapies
This is a multicenter, prospective, single-arm treatment study aimed at evaluating the feasibility, safety, and clinical effectiveness of the Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) as a temporary intervention for managing severe postpartum hemorrhage (PPH) caused by uterine atony unresponsive to standard first-line treatments. The study will be conducted across several sites in Ukraine, in regions affected by armed conflict, where access to surgical care and blood products may be delayed. Eligible participants are postpartum women aged 18 or older who experience primary PPH with estimated blood loss greater than 1000 mL and who do not respond to uterotonics or balloon tamponade. Patients with hemorrhage due to trauma, coagulopathy, or retained placental tissue will be excluded. When standard interventions fail and eligibility is confirmed, the AAJT-S device will be applied to the upper abdomen and inflated to 250 mmHg to temporarily occlude the abdominal aorta and inferior vena cava. This intervention aims to reduce pelvic blood flow and control bleeding, buying critical time to assemble the surgical team, initiate blood transfusion, and establish anesthesia.
Age
18 - 50 years
Sex
FEMALE
Healthy Volunteers
No
Olexandrivska Hospital
Zaporizhzhia, Ukraine
Start Date
July 1, 2025
Primary Completion Date
June 1, 2026
Completion Date
July 1, 2026
Last Updated
October 7, 2025
20
ESTIMATED participants
Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)
DEVICE
Lead Sponsor
LLC UkrMedGroup
NCT05290129
NCT05245227
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06646653