Abdominal Aortic Junction Tourniquet (AAJT-S) for Non-com... | NCT06622317

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

NCT06622317

Sponsor

Medical University of Graz

Status

Recruiting

Last Update Posted

Apr 17, 2025Actual

Enrollment

10Estimated

Phase

Not provided

Conditions

Exanguination
NCTH
Polytrauma

Interventions

Not provided

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2024Actual

Primary Completion Date

Sep 17, 2026Estimated

Completion Date

Jan 1, 2027Estimated

First Submitted Date

Sep 10, 2024

First Submission Date that Met QC Criteria

Oct 1, 2024

First Posted Date

Oct 2, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 14, 2025

Last Update Posted Date

Apr 17, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
effective placement of the device	cessation of bloodflow distal to the device	1 hour

Secondary Outcomes

Measure	Description	Time Frame
30-day mortality	in-hospital	30 days
Complications	Occurrence of complications of device application	90 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Gabriel Honnef, MD, PhD	Contact	004331638581283		gabriel.honnef@medunigraz.at

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of Graz	Recruiting	Graz	Styria	8010	Austria

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided