NCT07274150

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
26mo left

Started Feb 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress11%
Feb 2026Jul 2028

First Submitted

Initial submission to the registry

November 18, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 10, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

December 10, 2025

Status Verified

October 1, 2025

Enrollment Period

2 years

First QC Date

November 18, 2025

Last Update Submit

November 27, 2025

Conditions

ExanguinationPolytraumaNCTH

Keywords

NCTHExanguinationAortic occlusion

Outcome Measures

Primary Outcomes (1)

  • effective placement of the device

    cessation of bloodflow distal to the device

    1 hour

Secondary Outcomes (3)

  • Outcome Measure

    30 days

  • Complications

    90 days

  • hemodynamic improvement after application

    1 hour

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Written consent of the participant after being informed
  • 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)
  • Thought to benefit from trauma resuscitation with AAJT-S or REBOA zone III
  • Traumatic cardiac arrest

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Graz

Graz, Styria, 8010, Austria

Location

MeSH Terms

Conditions

Multiple Trauma

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Gabriel Honnef, MD, PhD

CONTACT

+436509160890gabriel.honnef@medunigraz.at

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2025

First Posted

December 10, 2025

Study Start

February 1, 2026

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

July 1, 2028

Last Updated

December 10, 2025

Record last verified: 2025-10

Locations

AU(1)