Blunt Traumatic Aortic Injury | NCT07490015

Studies
Blunt Traumatic Aortic Injury

NCT07490015

Sponsor

Methodist Health System

Status

Active, not recruiting

Last Update Posted

Jun 25, 2026Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Blunt Traumatic Aortic Injury
BTAI

Interventions

Not provided

Countries

United States

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

Jun 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 8, 2024Actual

Primary Completion Date

Dec 2028Estimated

Completion Date

Dec 2028Estimated

First Submitted Date

Mar 18, 2026

First Submission Date that Met QC Criteria

Mar 18, 2026

First Posted Date

Mar 24, 2026Actual

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

Jun 23, 2026

Last Update Posted Date

Jun 25, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a retrospective and prospective multi-center observational study of the management and outcomes of BTAI. This study will include patients who meet the registry inclusion criteria as documented in EPIC and chart review will start from January 2019 and December 2028. Data and endpoints will be observational and involve no prescribed therapeutic interventions or alterations in patient care. Institutions and providers will conduct normal diagnosis, management, and surveillance procedures without interference of this study.

Detailed Description

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

30 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary objective of this study is to establish a database of information that will allow the presentation, diagnosis, management, and outcomes of BTAI to be analyzed.		January 2019 and December 2028

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

≥ 18 years old
Computed tomography (CT)/CT angiography, angiographic, or intravascular ultrasound diagnosis of injury of the thoracic aorta

Exclusion Criteria:

< 18 years old
Patients without a diagnosis of vascular injury
Patients who were initially treated for their vascular injury at a prior medical facility

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

• ≥ 18 years old

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Methodist Dallas Medical Center		Dallas	Texas	75203	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided