CClinicalTrials.gg
Status unknownNCT05305690Updated Mar 31, 2022

Natural History and Nonoperative Management of Penetrating Cerebrovascular Injury

An observational study in Cerebrovascular Trauma, sponsored by Poudre Valley Health System. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-31.

Sponsored by Poudre Valley Health System · Observational

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
20
Ages
18 Years and older
Sex
All
01

Study summary

The goal of this study is to evaluate a series of cases of penetrating cerebrovascular injury managed without upfront operation. Investigators focus on patient characteristics, injury details, treatment modalities, serial imaging studies, patient outcomes, and complications. Investigators will compare this patient population to patients managed with upfront operation for context.

Read the detailed description

Penetrating cerebrovascular injuries (PCVIs) are uncommon, with little data to guide management when emergent operative repair is not performed. Investigators hypothesized that PCVIs may be managed with antithrombotic therapy and directed use of endovascular interventions, but that PCVIs may require enhanced surveillance due to a risk of delayed complications. To perform this study, investigators will review patients with penetrating carotid and vertebral artery injuries managed at an urban Level I trauma center from 2016 to 2022. Patients will be included if they underwent initial nonoperative management (NOM). Patient characteristics, injury details, treatments, serial imaging, outcomes, and complications will be assessed in a retrospective manner using chart abstraction. Investigators will briefly compare these patients to those managed with upfront operations for context.

02

Conditions studied

  • Cerebrovascular Trauma

Keywords

  • penetrating cerebrovascular injury
  • nonoperative management
  • penetrating neck trauma
  • natural history
  • antithrombotic therapy
  • case series
03

In context

Lead sponsor

Poudre Valley Health System is the lead sponsor of 15 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Investigators are including all adult patients with penetrating cerebrovascular injury since 5/1/2016 to present. Investigators will focus on those managed without operative intervention, but will include cases managed operatively for comparison.

Eligibility criteria

Inclusion Criteria:

  • Penetrating neck trauma
  • Carotid or vertebral artery injury
05

Study design

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

Groups and cohorts

  • Penetrating cerebrovascular injury, managed nonoperatively

    PCVI from penetrating trauma without upfront operation

    Other: No intervention

  • Penetrating cerebrovascular injury, managed operatively

    Other: No intervention

Interventions

  • OtherNo intervention

    This study did is a retrospective case series and does not involve an intervention. Investigators will compare patients managed operatively vs nonoperatively, focused on nonoperative therapy.

06

What researchers measure

Primary outcomes

  1. number of patients with stroke

    ischemic stroke

    Time frame: up to one year post-injury

Secondary outcomes

  1. number of patients with injury progression

    CTA progression of PCVI severity (Grade)

    Time frame: up to one year post-injury

  2. number of patients with death

    death

    Time frame: up to one year post-injury

  3. number of patients with bleeding complications

    intracranial hemorrhage, GI bleed, etc requiring change in treatment

    Time frame: up to one year post-injury

  4. number of patients treated with operative exploration

    All patients in cohort are treated with initial trial of nonoperative management. This outcome assesses the number of patients who subsequently required operative neck exploration. This is readily attainable from operative reports.

    Time frame: up to one year post-injury

  5. number of patients treated with arterial embolization or arterial stent placement

    IR procedures are adjuncts to nonoperative management. Performance of these procedures is readily attainable from IR procedure reports.

    Time frame: up to one year post-injury

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — Data is not readily sharable due to HIPAA restrictions

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05305690
Lead sponsor
Poudre Valley Health System
Collaborators
Denver Health Medical Center
Responsible party
Cordelie Witt (Investigator, Poudre Valley Health System) — Principal investigator
First posted
Mar 31, 2022
Start date
May 1, 2016
Primary completion
Jan 3, 2023 (estimated)
Completion
Jan 3, 2023 (estimated)
Last update
Mar 31, 2022

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion