Temporary Aortic Occlusion With the Abdominal Tourniquet for Refractory Postpartum Haemorrhage: A Proof-of-Concept Study in a War-Affected Region

This prospective, open-label, non-randomized, proof-of-concept study will assess the feasibility, safety, and preliminary clinical effectiveness of the Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) device as a temporizing measure for severe postpartum hemorrhage (PPH) due to uterine atony that is unresponsive to standard first-line therapies. The study will be conducted in a tertiary referral center in Zaporizhzhia, Ukraine, located in a conflict-affected region with limited access to timely surgical intervention and blood products.

Eligible participants will be adult postpartum patients (≥18 years) who develop primary PPH with blood loss exceeding 1,000 mL and who fail to respond to pharmacologic uterotonics and balloon tamponade. Patients with hemorrhage due to trauma, coagulopathy, or retained placental tissue will be excluded.

Once standard management protocols are exhausted and eligibility is confirmed, the AAJT-S device will be deployed over the upper abdomen and inflated to 250 mmHg to achieve temporary occlusion of the abdominal aorta and inferior vena cava. The device is intended to reduce pelvic blood flow and thereby control hemorrhage during the critical window required to mobilize a surgical team, arrange blood transfusion, and secure anesthesia.

The device will remain in place for a maximum of 60 minutes, consistent with published safety guidelines. Clinical endpoints will include time to bleeding control, hemodynamic stabilization, need for additional surgical intervention, and total blood loss. Safety endpoints will include thrombotic events, ischemic injury, infections, and any other adverse events related to device use.

Data will be collected prospectively, including demographic characteristics, obstetric history, timing and duration of interventions, and perioperative outcomes. Descriptive statistics will be used to summarize findings, with no formal hypothesis testing due to the pilot nature of the study.