At a glance
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Temporary Aortic Occlusion With the Abdominal Tourniquet for Refractory Postpartum Haemorrhage: A Proof-of-Concept Study in a War-Affected Region
In Brief
A clinical study evaluating Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) for Postpartum Haemorrhage (PPH). Completed, enrolled 4 participants across 1 site.
Detailed Summary
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?
Study Details
Timeline
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.