Natural History and Nonoperative Management of Penetrating Cerebrovascular Injury

Sponsor
Poudre Valley Health System (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05305690
Collaborator
Denver Health Medical Center (Other)
20
80.1

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention

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

Study Type:
Observational
Anticipated Enrollment :
20 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
Natural History and Nonoperative Management of Penetrating Cerebrovascular Injury
Actual Study Start Date :
May 1, 2016
Anticipated Primary Completion Date :
Jan 3, 2023
Anticipated Study Completion Date :
Jan 3, 2023

Arms and Interventions

Arm Intervention/Treatment
Penetrating cerebrovascular injury, managed nonoperatively

PCVI from penetrating trauma without upfront operation

Other: No 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.

Penetrating cerebrovascular injury, managed operatively

Other: No 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.

Outcome Measures

Primary Outcome Measures

  1. number of patients with stroke [up to one year post-injury]

    ischemic stroke

Secondary Outcome Measures

  1. number of patients with injury progression [up to one year post-injury]

    CTA progression of PCVI severity (Grade)

  2. number of patients with death [up to one year post-injury]

    death

  3. number of patients with bleeding complications [up to one year post-injury]

    intracranial hemorrhage, GI bleed, etc requiring change in treatment

  4. number of patients treated with operative exploration [up to one year post-injury]

    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.

  5. number of patients treated with arterial embolization or arterial stent placement [up to one year post-injury]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Penetrating neck trauma

  • Carotid or vertebral artery injury

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Poudre Valley Health System
  • Denver Health Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cordelie Witt, Investigator, Poudre Valley Health System
ClinicalTrials.gov Identifier:
NCT05305690
Other Study ID Numbers:
  • 19-0647
First Posted:
Mar 31, 2022
Last Update Posted:
Mar 31, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Cordelie Witt, Investigator, Poudre Valley Health System
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 31, 2022