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Temporary Aortic Compression With the Abdominal Tourniquet for Refractory Postpartum Hemorrhage
Sponsor: LLC UkrMedGroup
Summary
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
Key Details
Gender
FEMALE
Age Range
18 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2025-07-01
Completion Date
2026-07
Last Updated
2025-10-07
Healthy Volunteers
No
Conditions
Interventions
Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)
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.
Locations (1)
Olexandrivska Hospital
Zaporizhzhia, Ukraine