The PROspective Observational Vascular Injury Trial (PROOVIT)

NCT05224635 | Enrolling By Invitation

• 1 other identifier: 062.TRA.2021.D
• Study Type: observational
• Target: 5,718
• Locations: 1 country
• Sites: 1

Brief Summary

Evidence suggests that the rate of treatable vascular injury is increasing due to improved pre-hospital strategies. The increased rate of vascular trauma occurs in an era of increased sub-specialization, shifting training paradigms and the emergence of endovascular therapies. These factors, in combination with the baseline complexity of vascular trauma, make it particularly important that the management of this injury pattern be evidence-based. However, because all forms and distributions of vascular injury represent only 4% to 9% of trauma admissions, meaningful study of one injury pattern, patient population, therapeutic or surveillance strategy is difficult at a single institution. Further complicating such efforts is the fact that vascular trauma is managed by a wide range of surgical and now endovascular specialists, further fragmenting even a busy trauma institution's experience with vascular injury.

Conditions

Vascular Injury

Outcome Measures

Primary Outcomes (1)

• establish an aggregate database

  establish an aggregate database of information of vascular trauma measured by Injury Severity Score (ISS): (range 0-75)

  the 1st of November 2021 through 1st of July 2024

Study Arms (1)

subjects presenting to the emergency room

Chart review will include subjects presenting to the emergency room from the 1st of November 2021 through 1st of July 2024.

Procedure: Vascular Injury

Interventions

Vascular Injury PROCEDURE

The Society of Vascular Surgery has established a robust vascular disease registry but this organization's focus is on vascular disease and lacks capture of the data points necessary to discern trauma-specific outcomes. Recent military experience from the United States and United Kingdom, including the Balad Vascular Registry and the Global War on Terror (GWOT) Vascular Registry have provided a contemporary assessment of wartime vascular injury, but again these studies have been retrospective case series and registry reviews. Furthermore, applications of lessons learned in wartime vascular injury do not completely translate to management in trauma centers in the United States.

subjects presenting to the emergency room

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

• Adult trauma patients; defined by the American College of Surgeons as individuals age: ≥16 years

You may qualify if:

• Adult trauma patients; defined by the American College of Surgeons as individuals age: ≥16 years
• CT/CTA, duplex, angiographic or clinical/ operative diagnosis of vascular injury following trauma
• Initial management at Methodist Dallas Medical Center

You may not qualify if:

• Age: \< 16 years
• No diagnosis of vascular injury
• Prisoner
• Subject transferred from another medical facility

Sponsors & Collaborators

• Methodist Health System: lead

Study Sites (1)

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

MeSH Terms

Conditions

Vascular System Injuries

Interventions

SPEG protein, human

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries

Study Officials

• Jennifer Burris, M.D.

  Methodist Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: February 4, 2022
• Study Start: December 30, 2021
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: March 27, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)