Clinical trial NCT05224635: The PROspective Observational Vascular Injury Trial (PROOVIT)
Official title: The PROspective Observational Vascular Injury Trial (PROOVIT)
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Vascular Injury
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2022-02-04
Enrollment: 5718
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: • Adult trauma patients; defined by the American College of Surgeons as individuals age: ≥16 years

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.

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.

Eligibility criteria: 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:

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

Primary outcomes:
measure: establish an aggregate database
timeFrame: the 1st of November 2021 through 1st of July 2024
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
Study officials:
affiliation: Methodist Health System
name: Jennifer Burris, M.D.
role: PRINCIPAL_INVESTIGATOR
References: