Clinical trial NCT07016568: Temporary Aortic Occlusion With the Abdominal Tourniquet for Refractory Postpartum Haemorrhage: A Proof-of-Concept Study in a War-Affected Region
Official title: Temporary Aortic Occlusion With the Abdominal Tourniquet for Refractory Postpartum Haemorrhage: A Proof-of-Concept Study in a War-Affected Region
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Postpartum Haemorrhage (PPH)
Keywords: uterine atony
postpartum haemorrhage
Emergency Obstetric Care
Aortic Compression
Lead sponsor: LLC UkrMedGroup
Sponsor class: INDUSTRY
First posted: 2025-06-11
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a prospective, single-arm, open-label proof-of-concept study. All eligible participants will receive the investigational intervention (AAJT-S device) as an adjunct to standard care for severe postpartum hemorrhage unresponsive to uterotonics and balloon tamponade. No comparator or control group is included. The study is designed to evaluate feasibility, safety, and preliminary clinical outcomes in a conflict-affected, resource-limited setting.
Primary purpose: TREATMENT

Brief 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?

Detailed description: 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.

All participants will receive routine inpatient follow-up, and longer-term outcomes will be assessed via scheduled in-person visits and structured telephone interviews at 6 and 12 months postpartum to evaluate for delayed complications and maternal recovery. The study is designed to generate preliminary data for further exploration of the AAJT-S device as a potential emergency tool for PPH management in resource-limited and crisis settings.

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

Primary outcomes:
measure: Time to bleeding control after AAJT-S device application
timeFrame: Within 10 minutes of AAJT-S device application
measure: Total measured blood loss (pre- and post-intervention)
timeFrame: From onset of PPH until bleeding is definitively controlled (typically within 1-6 hours)
measure: Incidence of device-related complications
timeFrame: From device application through hospital discharge (up to 7 days)
Secondary outcomes:
measure: Hemodynamic stabilization time
timeFrame: First 60 minutes after AAJT-S application
measure: Long-term maternal recovery status
timeFrame: At 6 and 12 months postpartum
Other outcomes:
Locations:
city: Zaporizhzhia
country: Ukraine
facility: Olexandrivska Hospital
Study officials:
affiliation: pirhospr@gmail.com
name: Viktor Oshovskyy, DMSc, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Soltan MH, Sadek RR. Experience managing postpartum hemorrhage at Minia University Maternity Hospital, Egypt: no mortality using external aortic compression. J Obstet Gynaecol Res. 2011 Nov;37(11):1557-63. doi: 10.1111/j.1447-0756.2011.01574.x. Epub 2011 Jun 16.
citation: Soltan MH, Faragallah MF, Mosabah MH, Al-Adawy AR. External aortic compression device: the first aid for postpartum hemorrhage control. J Obstet Gynaecol Res. 2009 Jun;35(3):453-8. doi: 10.1111/j.1447-0756.2008.00975.x.
citation: Kheirabadi BS, Dubick MA. Safe duration of Abdominal Aortic and Junctional Tourniquet application. J Trauma Acute Care Surg. 2019 Sep;87(3):740-741. doi: 10.1097/TA.0000000000002231. No abstract available.
citation: Nieto-Calvache AJ, Palacios-Jaraquemada JM, Aryananda RA, Basanta N, Cininta N, Rivera-Torres LF, Bautista E, Hussein AM. External aortic compression: buying time to save lives in obstetric hemorrhage. Am J Obstet Gynecol. 2025 Feb;232(2):239-241. doi: 10.1016/j.ajog.2024.09.017. Epub 2024 Sep 18. No abstract available.
citation: Riley DP, Burgess RW. External abdominal aortic compression: a study of a resuscitation manoeuvre for postpartum haemorrhage. Anaesth Intensive Care. 1994 Oct;22(5):571-5. doi: 10.1177/0310057X9402200512.
citation: Nieto-Calvache AJ, Palacios Jaraquemada JM, Basanta N, Aryananda RA, Sinisterra-Diaz SE, Rodriguez F, Hidalgo Cardona A, Messa Bryon A. Internal manual compression of the aorta-an effective way to temporarily control pelvic bleeding in obstetrical hemorrhage. Am J Obstet Gynecol. 2022 Jul;227(1):96-97. doi: 10.1016/j.ajog.2022.02.040. Epub 2022 Mar 4.
citation: Khan M, Jeyanathan J, Smith JE. Novel use for the abdominal tourniquet in the management of postpartum haemorrhage. J R Army Med Corps. 2018 Nov;164(6):463. doi: 10.1136/jramc-2018-000953. Epub 2018 Apr 6. No abstract available.