Vascular InjuryNCT05224635
The PROspective Observational Vascular Injury Trial (PROOVIT)
An observational study of Vascular Injury, run by Methodist Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Vascular Injury
- What is being tested?
- Vascular Injury
- Type of treatment
- Surgery or procedure
- How many people
- 5,718 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Dec 2021to 30 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Child, Adult, Older adult
Study population: • Adult trauma patients; defined by the American College of Surgeons as individuals age: ≥16 years
Who may be able to join
- 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
Who cannot join
- Age: < 16 years
- No diagnosis of vascular injury
- Prisoner
- Subject transferred from another medical facility
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Methodist Dallas Medical Center
Dallas, Texas, 75203
About this study
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.
- Conditions
- Vascular Injury
- Being tested
- Vascular Injury
- Medical subject headings
- Vascular System Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vascular InjuryProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Vascular Injury |
What is being measured
The primary outcome is the main question the study is designed to answer.
establish an aggregate database
establish an aggregate database of information of vascular trauma measured by Injury Severity Score (ISS): (range 0-75)
Measured: the 1st of November 2021 through 1st of July 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start30 Dec 2021
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 5,718 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Burris, M.D., Principal investigator, Methodist Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05224635
- Sponsor's protocol ID
- 062.TRA.2021.D
- Status last verified
- May 2026
- First submitted
- 3 Feb 2022
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PROspective Observational Vascular Injury Trial (PROOVIT)
- ClinicalTrials.gov ID
- NCT05224635
- Acronym / sponsor ID
- 062.TRA.2021.D
- Conditions
- Vascular Injury
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 5,718 participants (estimated)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 30 Dec 2021 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 4 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| subjects presenting to the emergency room | – | Procedure: Vascular InjuryChart review will include subjects presenting to the emergency room from the 1st of November 2021 through 1st of July 2024. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- • Adult trauma patients; defined by the American College of Surgeons as individuals age: ≥16 years
Key inclusion criteria (3 listed)
- Adult trauma patients; defined by the American College of Surgeons as individuals age: ≥16 years
Key exclusion criteria (4 listed)
- Age: < 16 years
- No diagnosis of vascular injury
- Prisoner
- Subject transferred from another medical facility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vascular InjuryThe 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. | Procedure or surgery | subjects presenting to the emergency room |
Primary outcome
establish an aggregate database
Time frame: the 1st of November 2021 through 1st of July 2024
establish an aggregate database of information of vascular trauma measured by Injury Severity Score (ISS): (range 0-75)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer Burris, M.D. principal investigator
Methodist Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Injury, run by Methodist Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
establish an aggregate database (time frame: the 1st of November 2021 through 1st of July 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.