Natural History and Nonoperative Management of Penetrating Cerebrovascular Injury

• Conditions: Cerebrovascular Trauma
• Interventions: Other: No intervention

• Registration Number: NCT05305690
• Lead Sponsor: Poudre Valley Health System

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.

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 Timeline

• Study Start: 2016-05-01
• Study First Submitted: 2022-02-25
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-22
• Last Update Submitted: 2022-03-22
• Study First Posted: 2022-03-31
• Last Update Posted: 2022-03-31
• Primary Completion: 2023-01-03
• Study Completion: 2023-01-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Penetrating neck trauma
• Carotid or vertebral artery injury

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Penetrating cerebrovascular injury, managed operatively	No intervention	-
Penetrating cerebrovascular injury, managed nonoperatively	No intervention	PCVI from penetrating trauma without upfront operation

Primary Outcome Measures

Name	Time	Method
number of patients with stroke	up to one year post-injury	ischemic stroke

Secondary Outcome Measures

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