MedTrace Logo

Temporary Aortic Compression With the Abdominal Tourniquet for Refractory Postpartum Hemorrhage

NCT07034924 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-10-07

No results posted yet for this study

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

Conditions

  • Postpartum Hemorrhage

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.

Sponsors & Collaborators

  • LLC UkrMedGroup

    lead INDUSTRY

Principal Investigators

  • Yevheniia Poliakova, Ph.D · LLC UkrMedGroup

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2026-06-30
Completion
2026-07-31
FDA Device
Yes

Countries

  • Ukraine

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07034924 on ClinicalTrials.gov