Trial Outcomes & Findings for Temporary Aortic Occlusion With the Abdominal Tourniquet for Refractory Postpartum Haemorrhage: A Proof-of-Concept Study in a War-Affected Region (NCT NCT07016568)

Results Overview

Defined as the time (in minutes) from inflation of the AAJT-S device to visible cessation of external vaginal bleeding in patients with severe postpartum hemorrhage due to uterine atony. Bleeding control will be determined by visual clinical assessment by the attending provider. This measure evaluates the immediate effectiveness of the intervention in stopping hemorrhage and buying time for definitive surgical management or transfusion.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

4 participants

Primary outcome timeframe

Within 10 minutes of AAJT-S device application

Results posted on

2025-10-17

Participant Flow

Participants were recruited at Olexandrivska Hospital (Zaporizhzhia, Ukraine) between December 2024 and April 2025. Recruitment was based on clinical diagnosis of refractory postpartum hemorrhage due to uterine atony, and all participants provided oral informed consent.

All enrolled participants (N=4) met the eligibility criteria and were assigned to the intervention arm. No screening failures, exclusions, or withdrawals occurred prior to device application.

Participant milestones

Participant milestones
Measure	Experimental: AAJT-S Device Intervention Arm Participants in this arm received 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 was applied to the upper abdomen and inflated to 250 mmHg to achieve temporary aortic occlusion for up to 60 minutes. The intervention was intended to temporize bleeding while definitive surgical treatment and blood transfusion are arranged.
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental: AAJT-S Device Intervention Arm n=4 Participants Participants in this arm received 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 was applied to the upper abdomen and inflated to 250 mmHg to achieve temporary aortic occlusion for up to 60 minutes. The intervention was intended to temporize bleeding while definitive surgical treatment and blood transfusion are arranged.
Age, Categorical <=18 years	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=4 Participants
Sex: Female, Male Female	4 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=4 Participants
Region of Enrollment Ukraine	4 Participants n=4 Participants
Parity	2.5 Births STANDARD_DEVIATION 1.7 • n=4 Participants
Estimated Blood Loss Prior to AAJT-S Application	1125 ml n=4 Participants

PRIMARY outcome

Timeframe: Within 10 minutes of AAJT-S device application

Defined as the time (in minutes) from inflation of the AAJT-S device to visible cessation of external vaginal bleeding in patients with severe postpartum hemorrhage due to uterine atony. Bleeding control will be determined by visual clinical assessment by the attending provider. This measure evaluates the immediate effectiveness of the intervention in stopping hemorrhage and buying time for definitive surgical management or transfusion.

Outcome measures

Outcome measures
Measure	AAJT-S Device Intervention Arm n=4 Participants 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.
Time to Bleeding Control After AAJT-S Device Application	2 Minutes Standard Deviation 0.01

PRIMARY outcome

Timeframe: From onset of PPH until bleeding is definitively controlled (typically within 1-6 hours)

Sum of blood loss (in mL), measured by pad/towel weights after AAJT-S use until definitive hemostasis.

Outcome measures

Outcome measures
Measure	AAJT-S Device Intervention Arm n=4 Participants 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.
Total Measured Blood Loss (Pre- and Post-intervention)	1425 ml Interval 1150.0 to 1800.0

PRIMARY outcome

Timeframe: From device application through hospital discharge (up to 7 days)

Includes thrombotic events, ischemic injury, skin necrosis, or technical malfunction during/after AAJT-S use.

Outcome measures

Outcome measures
Measure	AAJT-S Device Intervention Arm n=4 Participants 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.
Incidence of Device-related Complications	0 Participants

SECONDARY outcome

Timeframe: First 60 minutes after AAJT-S application

Time from device inflation to achievement of target blood pressure (SBP ≥90 mmHg) and pulse \<110 bpm.

Outcome measures

Outcome measures
Measure	AAJT-S Device Intervention Arm n=4 Participants 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.
Hemodynamic Stabilization Time	31.25 Minutes Standard Deviation 6.29

SECONDARY outcome

Timeframe: At 6 weeks postpartum

Assessed via follow-up calls and scheduled ultrasound visits at 6 weeks postpartum, including return to normal activity, presence of chronic pain, or menstrual abnormalities.

Outcome measures

Outcome measures
Measure	AAJT-S Device Intervention Arm n=4 Participants 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.
Long-term Maternal Recovery Status	4 Participants

Adverse Events

AAJT-S Device Intervention Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Yevheniia Poliakova

LLC UkrMedGroup

Phone: +380502818399

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place