Abdominal Aortic Junction Tourniquet (AAJT-S) for Non-compressible Torso Haemorrhage in the Prehospital and Emergency Room Setting

Abdominal Aortic Junction Tourniquet (AAJT-S) for Non-compressible Torso Haemorrhage A Prospective Multicentre-study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Polytrauma; Exanguination; NCTH

Detailed Description

Much like REBOA, AAJT-S can potentially stop blood flow distal to the device and therefore improve proximal aortic perfusion, minimize haemorrhage and stabilize patients until definite surgical repair/bleeding control is feasible. In contrast to REBOA, there is no need of femoral access and therefore, appropriate training is easily achieved.

This study seeks to gather further information on the benefits and potential harms of this intervention on a multicentre level.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Gabriel Honnef, MD, PhD; Phone Number: +436509160890; Email: gabriel.honnef@medunigraz.at

Study Locations

• Austria
  • Styria
    • Graz, Styria, Austria, 8010
      • Medical University of Graz
      • Contact: Gabriel Honnef, MD, PhD; Phone Number: 06509160890; Email: gabriel.honnef@medunigraz.at
      • Contact: Email: ghonnef@gmail.com
      • Principal Investigator: Gabriel Honnef, MD, PhD
      • Sub-Investigator: Philipp Zoidl, MD
      • Sub-Investigator: Paul Puchwein, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

1. Suspected additional bleeding source proximal to the umbilicus
2. Known or suspected pregnancy at presentation
3. Known abdominal aortic aneurysm

Description

Inclusion Criteria:

1. Written consent of the participant after being informed
2. Aged, or believed to be aged, 18 years or above
3. Confirmed or suspected life-threatening lower body trauma (i.e. signs of inadequate perfusion of tissues, tachycardia, hypotension, suspected blood loss)
4. Thought to benefit from trauma resuscitation with AAJT-S or REBOA zone III
5. Traumatic cardiac arrest

Exclusion Criteria:

-

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
effective placement of the device	cessation of bloodflow distal to the device	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	Occurrence of complications of device application	90 days
Outcome Measure	30-day in hospital mortality	30 days
hemodynamic improvement after application	lower hart rate / higher blood pressure (improvement in bpm/mmHg)	1 hour

Collaborators and Investigators

• Sponsor: Medical University of Graz

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: November 27, 2025
• First Posted (Actual): December 10, 2025

Study Record Updates

• Last Update Posted (Actual): December 10, 2025
• Last Update Submitted That Met QC Criteria: November 27, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: NCTH; Exanguination; Aortic occlusion
• Additional Relevant MeSH Terms: Wounds and Injuries; Multiple Trauma
• Other Study ID Numbers: 1331/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No