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

Abdominal Aortic Junction Tourniquet (AAJT-S) for Non-compressible Torso Haemorrhage: a Prospective Observational Pilot Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06622317
Enrollment
10
Registered
2024-10-02
Start date
2024-11-01
Completion date
2027-01-01
Last updated
2025-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exanguination, NCTH, Polytrauma

Keywords

NCTH, aortic occlusion, exanguniation

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.

Interventions

None listed

Sponsors

Medical University of Graz
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
effective placement of the device1 hourcessation of bloodflow distal to the device

Secondary

MeasureTime frameDescription
30-day mortality30 daysin-hospital
Complications90 daysOccurrence of complications of device application
Heart rate1 hourImprovement (reduction) in beats/minute
Base excess1hourImprovement (reduction) in mmol/l
Blood pressure (systolic and diastolic)1 hourImprovement in mmHg

Countries

Austria

Contacts

Primary ContactGabriel Honnef, MD, PhD
gabriel.honnef@medunigraz.at004331638581283

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026