Natural History and Nonoperative Management of Penetrating Cerebrovascular Injury

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cerebrovascular Trauma
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 20

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

• Penetrating neck trauma
• Carotid or vertebral artery injury

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of patients with stroke	ischemic stroke	up to one year post-injury

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of patients with injury progression	CTA progression of PCVI severity (Grade)	up to one year post-injury
number of patients with death	death	up to one year post-injury
number of patients with bleeding complications	intracranial hemorrhage, GI bleed, etc requiring change in treatment	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.	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.	up to one year post-injury

Collaborators and Investigators

• Sponsor: Poudre Valley Health System
• Collaborators: Denver Health Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Anticipated): January 3, 2023
• Study Completion (Anticipated): January 3, 2023

Study Registration Dates

• First Submitted: February 25, 2022
• First Submitted That Met QC Criteria: March 22, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 22, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: antithrombotic therapy; natural history; penetrating cerebrovascular injury; nonoperative management; penetrating neck trauma; case series
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Cerebrovascular Trauma
• Other Study ID Numbers: 19-0647

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Data is not readily sharable due to HIPAA restrictions

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No