Temporary abdominal aortic compression with the AAJT-S for severe postpartum bleeding
Temporary Aortic Compression With the Abdominal Tourniquet for Refractory Postpartum Hemorrhage
This will try using the AAJT-S abdominal tourniquet to stop severe postpartum bleeding in women whose bleeding does not stop with usual treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | LLC UkrMedGroup Industry-sponsored |
| Locations | 1 site (Zaporizhzhia) |
| Trial ID | NCT07034924 on ClinicalTrials.gov |
What this trial studies
This is a multicenter, prospective, single-arm study in conflict-affected regions of Ukraine testing the AAJT-S abdominal aortic and junctional tourniquet as a temporary measure for severe PPH due to uterine atony that is refractory to uterotonics and intrauterine balloon tamponade. When eligibility is confirmed and standard measures have failed, the AAJT-S is applied to the upper abdomen and inflated to 250 mmHg to temporarily occlude the abdominal aorta and reduce pelvic blood flow. The study will collect feasibility, safety, and clinical effectiveness outcomes including control of bleeding, need for definitive surgery or hysterectomy, transfusion requirements, and device-related adverse events. The intent is to buy time to assemble surgical teams, initiate transfusion, and establish anesthesia where access to definitive care may be delayed.
Who should consider this trial
Good fit: Postpartum women aged 18 or older with primary PPH (estimated blood loss >1300 mL) from uterine atony that has not responded to uterotonics and balloon tamponade, who can provide oral informed consent prior to device application, are the intended candidates.
Not a fit: Patients whose bleeding is due to trauma, retained placental tissue, or primary coagulopathy (all exclusion criteria) are unlikely to benefit from this aortic compression approach.
Why it matters
Potential benefit: If successful, the device could rapidly reduce pelvic blood loss and buy critical time to reach definitive care, potentially lowering mortality, transfusion needs, and emergency hysterectomy rates.
How similar studies have performed: Aortic and junctional tourniquets have shown some success in trauma and emergency settings, but their use specifically for refractory PPH is relatively novel with only limited case reports and small series.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Patients with postpartum bleeding as a result of trauma, retained placenta or coagulopathy were excluded
Where this trial is running
Zaporizhzhia
- Olexandrivska Hospital — Zaporizhzhia, Ukraine (Recruiting)
Study contacts
- Principal investigator: Yevheniia Poliakova, Ph.D — LLC UkrMedGroup
- Study coordinator: Yevheniia Poliakova, Ph.D
- Email: jenyapolyakova@gmail.com
- Phone: +380502818399
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.