NCT06622317

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

77
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
8mo left

Started Nov 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Nov 2024Jan 2027

First Submitted

Initial submission to the registry

September 10, 2024

Completed
22 days until next milestone

First Posted

Study publicly available on registry

October 2, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 17, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

April 17, 2025

Status Verified

April 1, 2025

Enrollment Period

1.9 years

First QC Date

September 10, 2024

Last Update Submit

April 14, 2025

Conditions

ExanguinationNCTHPolytrauma

Keywords

NCTHaortic occlusionexanguniation

Outcome Measures

Primary Outcomes (1)

  • effective placement of the device

    cessation of bloodflow distal to the device

    1 hour

Secondary Outcomes (5)

  • 30-day mortality

    30 days

  • Complications

    90 days

  • Heart rate

    1 hour

  • Base excess

    1hour

  • Blood pressure (systolic and diastolic)

    1 hour

Eligibility Criteria

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

all patients meeting the eligibility criteria that are being transported to the rescucitation room of the Medical University of Graz

You may qualify if:

  • 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

You may not qualify if:

  • suspected additional bleeding source proximal to the umbilicus, or
  • known or suspected pregnancy at presentation, or
  • known abdominal aortic aneurysm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Graz

Graz, Styria, 8010, Austria

RECRUITING

MeSH Terms

Conditions

Multiple Trauma

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Gabriel Honnef, MD, PhD

CONTACT

004331638581283gabriel.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

September 10, 2024

First Posted

October 2, 2024

Study Start

November 1, 2024

Primary Completion (Estimated)

September 17, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

April 17, 2025

Record last verified: 2025-04

Locations

AU(1)