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

NCT ID: NCT06622317

Last Updated: 2025-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-01

Study Completion Date

2027-01-01

Brief Summary

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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

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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.

Conditions

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Exanguination NCTH Polytrauma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Graz

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Medical University of Graz

Graz, Styria, Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Gabriel Honnef, MD, PhD

Role: CONTACT

004331638581283

Facility Contacts

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Gabriel Honnef, MD, PhD

Role: primary

Other Identifiers

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1063/2024

Identifier Type: -

Identifier Source: org_study_id

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