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NCT Number: NCT06622317

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

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.

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Key information

Conditions

Exanguination Multiple Trauma NCTH Polytrauma Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Graz

Graz, Styria, 8010, Austria

Location status: Recruiting

Location contact

Gabriel Honnef, MD, PhD

CONTACT

[email protected]

81283

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. effective placement of the device

    Time frame: 1 hour

    cessation of bloodflow distal to the device

Secondary outcomes

  1. 30-day mortality

    Time frame: 30 days

    in-hospital

  2. Complications

    Time frame: 90 days

    Occurrence of complications of device application

  3. Heart rate

    Time frame: 1 hour

    Improvement (reduction) in beats/minute

  4. Base excess

    Time frame: 1hour

    Improvement (reduction) in mmol/l

  5. Blood pressure (systolic and diastolic)

    Time frame: 1 hour

    Improvement in mmHg

Study contacts

Contact information is provided by the study sponsor or research team.

Gabriel Honnef, MD, PhD

CONTACT

[email protected]

004331638581283

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Oct 2, 2024
Registry last updated
Apr 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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