Abdominal Aortic Junction Tourniquet (AAJT-S) for Non-compressible Torso Haemorrhage

Recruiting

• Conditions: Exanguination; NCTH; Polytrauma

• Registration Number: NCT06622317
• Lead Sponsor: Medical University of Graz

Brief Summary

This study seeks to evaluate the feasibility of a Abdominal Aortic Balloon Occlusion of the Aorta (AAJT-S) in exanguinating trauma patients with non-compressible truncal haemorrhage in the emergency room and the pre-hospital setting.

Detailed Description

The study is designed as a prospective observational study to accomapany the impementation of this device in clinical routine. However, the device has already been used in the emergency room and AAJT-S application is no study specific intervention.

Study Timeline

• Study First Submitted: 2024-09-10
• Study First Submitted QC: 2024-10-01
• Study First Posted: 2024-10-02
• Study Start: 2024-11-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-17
• Primary Completion: 2026-09-17
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• aged, or believed to be aged, 18 years or above,
• confirmed or suspected life-threatening lower body trauma (i.e. signs of inadequate perfusion of tissues, tachycardia, hypotension, suspected blood loss)
• is thought to benefit from trauma resuscitation with AAJT-S or REBOA zone III

Exclusion Criteria

• suspected additional bleeding source proximal to the umbilicus, or
• known or suspected pregnancy at presentation, or
• known abdominal aortic aneurysm

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
effective placement of the device	1 hour	cessation of bloodflow distal to the device

Secondary Outcome Measures

Name	Time	Method
30-day mortality	30 days	in-hospital
Complications	90 days	Occurrence of complications of device application
Heart rate	1 hour	Improvement (reduction) in beats/minute
Base excess	1hour	Improvement (reduction) in mmol/l
Blood pressure (systolic and diastolic)	1 hour	Improvement in mmHg

Trial Locations

Locations (1)

Medical University of Graz; 🇦🇹 Graz, Styria, Austria