The PROspective Observational Vascular Injury Trial (PROOVIT)

Conditions

• Vascular Injury

Eligibility Criteria

Sex

ALL

Age

16 Years - N/A

Healthy Volunteers

Not accepted

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.

Study Details

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.

Key Dates

Start date

Dec 30, 2021

Status verified

May 2026

Primary completion

Dec 30, 2027

Completion

Dec 30, 2028

Study Design

Enrollment

5,718 participants (estimated)

Arms

• Arm: 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.

Primary Outcome Measure

establish an aggregate database [ Time Frame: the 1st of November 2021 through 1st of July 2024 ]

Locations (1)

Find similar trials in Dallas, TX

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