Temporary Aortic Compression With the Abdominal Tourniquet for Refractory Postpartum Hemorrhage (ACT-PPH)

LLC UkrMedGroup

Status: Enrolling

Conditions: Postpartum Hemorrhage

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT07034924

2025/EC/15051

Details and patient eligibility

About

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

Full description

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.

Enrollment: 20 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Participant Group/Arm

Experimental group

Description:

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.

Treatment:

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