Cerebrovascular TraumaNCT05305690
Natural History and Nonoperative Management of Penetrating Cerebrovascular Injury
An observational study of Cerebrovascular Trauma, run by Poudre Valley Health System.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebrovascular Trauma
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2016to 3 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Penetrating neck trauma
- Carotid or vertebral artery injury
Who cannot join
None listed.
About this study
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.
- Conditions
- Cerebrovascular Trauma
- Being tested
- No intervention
- Keywords
- penetrating cerebrovascular injury, nonoperative management, penetrating neck trauma, natural history, antithrombotic therapy, case series
- Medical subject headings
- Cerebrovascular Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Penetrating cerebrovascular injury, managed nonoperatively | PCVI from penetrating trauma without upfront operation Receives: Other: No intervention | |
| Penetrating cerebrovascular injury, managed operatively | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients with stroke
ischemic stroke
Measured: up to one year post-injury
Secondary outcomes (5)
number of patients with injury progression
CTA progression of PCVI severity (Grade)
Measured: up to one year post-injury
number of patients with death
death
Measured: up to one year post-injury
number of patients with bleeding complications
intracranial hemorrhage, GI bleed, etc requiring change in treatment
Measured: up to one year post-injury
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.
Measured: up to one year post-injury
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.
Measured: up to one year post-injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start1 May 2016
- Primary completion3 Jan 2023 (estimated)
- Study completion3 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular TraumaStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poudre Valley Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Denver Health Medical Center
- Responsible party
- Principal investigator, Cordelie Witt, Poudre Valley Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05305690
- Sponsor's protocol ID
- 19-0647
- Status last verified
- Mar 2022
- First submitted
- 25 Feb 2022
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data is not readily sharable due to HIPAA restrictions
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural History and Nonoperative Management of Penetrating Cerebrovascular Injury
- ClinicalTrials.gov ID
- NCT05305690
- Acronym / sponsor ID
- 19-0647
- Conditions
- Cerebrovascular Trauma
- Keywords
- penetrating cerebrovascular injury, nonoperative management, penetrating neck trauma, natural history, antithrombotic therapy, case series
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Poudre Valley Health SystemUniversity, hospital or other
- Collaborators
- Denver Health Medical Center
- Study start
- 1 May 2016 (actual)
- Primary completion
- 3 Jan 2023 (estimated)
- Study completion
- 3 Jan 2023 (estimated)
- First posted
- 31 Mar 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.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Penetrating cerebrovascular injury, managed nonoperatively | – | Other: No interventionPCVI from penetrating trauma without upfront operation |
| Penetrating cerebrovascular injury, managed operatively | – | Other: No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Penetrating neck trauma
- Carotid or vertebral artery injury
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| No interventionThis 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. | Other | Penetrating cerebrovascular injury, managed nonoperatively, Penetrating cerebrovascular injury, managed operatively |
Primary outcome
number of patients with stroke
Time frame: up to one year post-injury
ischemic stroke
5 secondary outcomes
number of patients with injury progression
Time frame: up to one year post-injury
number of patients with death
Time frame: up to one year post-injury
number of patients with bleeding complications
Time frame: up to one year post-injury
number of patients treated with operative exploration
Time frame: up to one year post-injury
number of patients treated with arterial embolization or arterial stent placement
Time frame: up to one year post-injury
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Individual participant dataSharing planned: No. Data is not readily sharable due to HIPAA restrictions
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebrovascular Trauma, run by Poudre Valley Health System.
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 2 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
number of patients with stroke (time frame: up to one year post-injury). 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 31 Mar 2022.