CClinicalTrials.gg
Enrolling by invitationNCT05224635Updated Jun 10, 2026

The PROspective Observational Vascular Injury Trial (PROOVIT)

An observational study in Vascular Injury, sponsored by Methodist Health System. Enrolling by invitation at 1 site in United States. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-06-10.

Sponsored by Methodist Health System · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
5,718
Ages
16 Years and older
Sex
All
01

Study 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.

Read the detailed description

Several institutions and groups have contributed important insight into the understanding of vascular injury management. However, many of the studies have been single-institution, poorly powered and retrospective. The lack of evidence-based practice is even more concerning given the devastating consequences associated with mismanaged vascular trauma. In light of the stated challenges associated with single-institution study of this injury pattern, the logical method with which to proceed is a prospective, multicenter, observational trail. To date no such registries exists which would allow the prospective aggregation of larger amounts of data pertaining to all phases of vascular trauma management.

Contemporary experience confirms that the management of vascular injury is more complicated than in the past. A multitude of new or updated diagnostic technologies including computed tomography angiography (CTA), magnetic resonance angiography (MRA), duplex and arteriography now exist and are in various degrees of vogue. A damage control approach to vascular trauma is widely championed and includes options for the use of tourniquets, temporary vascular shunts and fasciotomies. Controversies regarding the definitive management of vascular trauma abound and include the advisability of open versus endovascular treatment, decisions about the type of vascular conduit and the utility of venous injury repair lo list a few. Recommendations for surveillance after vascular trauma may include the use of duplex ultrasound or CTA to confirm long-term patency as well as choices related to the use of long-term anti-thrombotic therapy. Finally, it is not uncommon for an institution to find itself facing many of these decision points in the most challenging of all scenarios, the extremes of age including pediatric vascular injury.

02

Conditions studied

  • Vascular Injury
03

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Age: \< 16 years
  • No diagnosis of vascular injury
  • Prisoner
  • Subject transferred from another medical facility
04

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
5,718 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • ProcedureVascular Injury

    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.

05

What researchers measure

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)

    Time frame: the 1st of November 2021 through 1st of July 2024

06

Study locations

1 site
  • Methodist Dallas Medical Center
    Dallas, Texas 75203, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05224635
Lead sponsor
Methodist Health System
Responsible party
Sponsor
First posted
Feb 4, 2022
Start date
Dec 30, 2021
Primary completion
Dec 30, 2027 (estimated)
Completion
Dec 30, 2028 (estimated)
Last update
Jun 10, 2026

Study contacts

Jennifer Burris, M.D.
principal investigator · Methodist Health System

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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