Temporary Aortic Compression With the Abdominal Tourniquet for Refractory Postpartum Hemorrhage
LLC UkrMedGroup
20 participants
Jul 1, 2025
INTERVENTIONAL
Conditions
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
Eligibility
Inclusion Criteria4
- Age ≥18 years
- Clinical diagnosis of postpartum hemorrhage (PPH) refractory to uterotonics and intrauterine balloon tamponade
- Estimated blood loss greater than 1300 mL
- Oral informed consent provided prior to device application
Exclusion Criteria1
- Patients with postpartum bleeding as a result of trauma, retained placenta or coagulopathy were excluded
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Interventions
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)
View Full Details on ClinicalTrials.gov
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NCT07034924