Temporary Aortic Occlusion With the Abdominal Tourniquet for Refractory Postpartum Haemorrhage: A Proof-of-Concept Study in a War-Affected Region

NACompletedINTERVENTIONAL
Enrollment

4

Participants

Timeline

Start Date

December 1, 2024

Primary Completion Date

April 15, 2025

Study Completion Date

April 30, 2025

Conditions
Postpartum Haemorrhage (PPH)
Interventions
DEVICE

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.

Trial Locations (1)

69000

Olexandrivska Hospital, Zaporizhzhia

All Listed Sponsors
lead

LLC UkrMedGroup

INDUSTRY

NCT07016568 - Temporary Aortic Occlusion With the Abdominal Tourniquet for Refractory Postpartum Haemorrhage: A Proof-of-Concept Study in a War-Affected Region | Biotech Hunter | Biotech Hunter