N/A
N=4
Temporary Aortic Occlusion With the Abdominal Tourniquet for Refractory Postpartum Haemorrhage: A Proof-of-Concept Study in a War-Affected Region
Postpartum Haemorrhage (PPH)
Bottom Line
View on ClinicalTrials.gov: NCT07016568 ↗Enrolled (actual)
4
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcome: Primary: Time to Bleeding Control After AAJT-S Device Application — 2 Minutes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) (Device)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- LLC UkrMedGroup
- Primary completion
- Apr 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Bleeding Control After AAJT-S Device Application |
2 | — |
| PRIMARY Total Measured Blood Loss (Pre- and Post-intervention) |
1425 | — |
| PRIMARY Incidence of Device-related Complications |
— | — |
| SECONDARY Hemodynamic Stabilization Time |
31.25 | — |
| SECONDARY Long-term Maternal Recovery Status |
4 | — |
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?
Eligibility Criteria
Inclusion Criteria
- Age ≥18 years
- Clinical diagnosis of postpartum hemorrhage (PPH) refractory to uterotonics and intrauterine balloon tamponade
- Estimated blood loss greater than 1, 000 mL
- Oral informed consent provided prior to device application
Exclusion Criteria
- Patients with postpartum bleeding as a result of trauma, retained placenta or coagulopathy were excluded
Data sourced from ClinicalTrials.gov (NCT07016568). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.