Temporary Aortic Compression With the Abdominal Tourniquet for Refractory Postpartum Hemorrhage

NCT07034924 | Recruiting DMC FDA Device

• 1 other identifier: 2025/EC/15051
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Postpartum Hemorrhage

Keywords

postpartum hemorrhage

Outcome Measures

Primary Outcomes (2)

• Efficacy: 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.

  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

  From device application until 6-week postpartum follow-up

Secondary Outcomes (1)

• Visually estimated blood loss (EBL)

  From delivery until AAJT-S placement

Study Arms (1)

Participant Group/Arm

EXPERIMENTAL

Participants in this arm will receive standard postpartum hemorrhage (PPH) management followed by application of the Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) device if bleeding remains uncontrolled after uterotonics and uterine balloon tamponade. The device will be applied to the upper abdomen and inflated to 250 mmHg to achieve temporary aortic occlusion for up to 60 minutes. The intervention is intended to temporize bleeding while definitive surgical treatment and blood transfusion are arranged.

Device: Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)

Interventions

Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) DEVICE

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.

Participant Group/Arm

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Patients with postpartum bleeding as a result of trauma, retained placenta or coagulopathy were excluded

Sponsors & Collaborators

• LLC UkrMedGroup: lead

Study Sites (1)

Olexandrivska Hospital

Zaporizhzhia, 69000, Ukraine

RECRUITING

Related Publications (7)

• 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.

  PMID: 29626141 BACKGROUND

• 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.

  PMID: 35248574 BACKGROUND

• 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.

  PMID: 7818062 BACKGROUND

• 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.

  PMID: 39304012 BACKGROUND

• 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.

  PMID: 30768561 BACKGROUND

• 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.

  PMID: 19527382 BACKGROUND

• 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.

  PMID: 21676082 BACKGROUND

Related Links

• Information about The Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yevheniia Poliakova, Ph.D

  LLC UkrMedGroup

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yevheniia Poliakova, Ph.D

CONTACT

+380502818399; jenyapolyakova@gmail.com

Viktor Oshovskyy, DMSc, PhD

CONTACT

+380991770303; pirhospr@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a prospective, single-arm, interventional treatment study designed to assess the effectiveness and safety of the AAJT-S device in the management of severe postpartum hemorrhage. All eligible participants will receive the same intervention without randomization or control group. Data will be collected in real time across multiple centers, and the study does not include blinding.

Study Record Dates

• First Submitted: June 15, 2025
• First Posted: June 24, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: October 7, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

UA (1)