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
This is a multicenter, prospective, single-arm treatment study aimed at evaluating the feasibility, safety, and clinical effectiveness of the Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) as a temporary intervention for managing severe postpartum hemorrhage (PPH) caused by uterine atony unresponsive to standard first-line treatments. The study will be conducted across several sites in Ukraine, in regions affected by armed conflict, where access to surgical care and blood products may be delayed. Eligible participants are postpartum women aged 18 or older who experience primary PPH with estimated blood loss greater than 1000 mL and who do not respond to uterotonics or balloon tamponade. Patients with hemorrhage due to trauma, coagulopathy, or retained placental tissue will be excluded. When standard interventions fail and eligibility is confirmed, the AAJT-S device will be applied to the upper abdomen and inflated to 250 mmHg to temporarily occlude the abdominal aorta and inferior vena cava. This intervention aims to reduce pelvic blood flow and control bleeding, buying critical time to assemble the surgical team, initiate blood transfusion, and establish anesthesia.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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.
Olexandrivska Hospital
Zaporizhzhia, Ukraine
RECRUITINGEfficacy: The proportion of cases achieving rapid hemorrhage control after AAJT-S application.
Visible cessation of external vaginal bleeding (no ongoing blood flow from the cervix or vaginal canal observed by the clinical team) within 5 minutes of device inflation. The attending obstetrician will visually assess bleeding immediately after inflation and every 30 seconds until 5 minutes. "Control" will be recorded at the first time point when no active bleeding is observed (slight spotting is not considered ongoing hemorrhage). If bleeding persists beyond 5 minutes, the case is classified as "failure of primary endpoint," even if subsequent control is achieved.
Time frame: Within 5 minutes of AAJT-S device application
Safety: Incidence (i.e., Rate or Number of Participants), Severity and Seriousness of Device-related Adverse Events from placement until 6-week postpartum follow-up
Any untoward medical occurrence temporally associated with the AAJT-S device, regardless of causality
Time frame: From device application until 6-week postpartum follow-up
Visually estimated blood loss (EBL)
Visually estimated blood loss (EBL) from delivery until AAJT-S placement (mL).
Time frame: From delivery until AAJT-S placement
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