Temporary Aortic Occlusion With the Abdominal Tourniquet for Refractory Postpartum Haemorrhage: A Proof-of-Concept Study in a War-Affected Region
Phase: NA
Conditions: Postpartum Haemorrhage (PPH)
Sponsor: LLC UkrMedGroup

Study Protocol  
Title 
Temporary Aortic Occlusion with the Abdominal Tourniquet for Refractory 
Postpartum Haemorrhage: A Proof-of-Concept Study in a War-Affected Region 
Version 
1.0 
Date 
November 1, 2024 
Principal Investigators 
Dr. Yevheniia Poliakova, MD, PhD — Olexandrivska Hospital, Zaporizhzhia 
Dr. Viktor Oshovskyy, MD, PhD, DMSc — Uniklinika Medical Centre, Kyiv 
Institution 
Olexandrivska Hospital, Zaporizhzhia, Ukraine 
Ethics Approval 
Approved by Olexandrivska Hospital Ethics Committee (Approval number: 
2024/EC/128094) 
 
1. Background and Rationale 
Postpartum haemorrhage (PPH) remains the leading cause of maternal mortality 
globally, especially in low-resource and crisis-affected settings. In Ukraine, full-scale war has 
disrupted medical infrastructure, limiting access to timely surgical interventions and blood 
transfusion. 
The AAJT-S (Abdominal Aortic and Junctional Tourniquet – Stabilized) is an FDA-
approved device for temporary aortic occlusion in trauma, but its use in obstetrics is not well 
studied. This study aims to evaluate the feasibility, safety, and preliminary clinical efficacy of 
AAJT-S in controlling refractory PPH due to uterine atony in a wartime environment. 
 
2. Objectives 
Primary Objective: 
• 
To assess whether the AAJT-S device can temporarily and safely control severe PPH 
in a resource-limited, high-risk setting. 
Secondary Objectives: 
• 
To describe feasibility of AAJT-S deployment by obstetric teams. 
• 
To evaluate maternal hemodynamic stabilization and procedural outcomes. 

• 
To monitor for short- and long-term complications (thrombosis, ischemia, infection, 
renal dysfunction). 
 
3. Study Design 
• 
Design: Prospective, open-label, non-randomized, proof-of-concept 
• 
Duration: December 2024 – April 2025 
• 
Setting: Olexandrivska Hospital, Zaporizhzhia, Ukraine 
• 
Sample Size: 4 patients 
 
4. Inclusion/Exclusion Criteria 
Inclusion Criteria: 
• 
Age ≥18 years 
• 
Primary PPH with blood loss >1000 mL 
• 
Refractory to uterotonics and uterine balloon tamponade 
• 
Oral informed consent obtained 
Exclusion Criteria: 
• 
PPH due to trauma, coagulopathy, or retained placenta 
• 
Inability to provide informed consent 
 
5. Intervention 
Application of the AAJT-S device over the upper abdomen (inflated to 250 mmHg) to 
achieve temporary aortic occlusion for ≤60 minutes. Device application was done following 
persistent bleeding despite standard therapy. 
 
6. Procedures 
• 
Initial PPH management per hospital protocol: oxytocin, misoprostol, 
methylergometrine, tranexamic acid, uterine massage, balloon tamponade 
• 
AAJT-S deployed in case of ongoing bleeding >1000 mL 
• 
Device monitored and deflated after stabilization or readiness for surgery 
• 
Surgical treatment (compression sutures, artery ligation) performed if bleeding 
resumed 
• 
Data captured: demographics, interventions, outcomes, adverse events 
• 
Follow-up: inpatient daily assessments, phone monitoring post-discharge, pelvic 
ultrasound at 6 and 12 months postpartum 

 
7. Outcomes 
Primary Outcome: 
• 
Control of bleeding within 2 minutes after AAJT-S application 
Secondary Outcomes: 
• 
Surgical readiness time gained 
• 
Total blood loss and transfusion requirements 
• 
Postoperative complications 
• 
Long-term recovery indicators 
 
8. Statistical Considerations 
Descriptive statistics only (medians, ranges); no hypothesis testing or power 
calculation due to pilot nature. Outcomes presented per individual case. 
 
9. Ethical Considerations 
• 
Approved by the institutional ethics committee (2024/EC/128094) 
• 
AAJT-S used off-label with oral informed consent 
• 
Risks and rationale explained to each participant 
 
10. Dissemination Plan 
• 
Results to be submitted for peer-reviewed publication 
• 
Presented at conferences on maternal health and obstetric innovation