Natural History and Nonoperative Management of Penetrating Cerebrovascular Injury

Cerebrovascular Trauma Clinical Trial

Official title:

Natural History and Nonoperative Management of Penetrating Cerebrovascular Injury

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05305690
• Other study ID #: 19-0647
• Status: Active, not recruiting
• Start date: May 1, 2016
• Est. completion date: January 3, 2023

Study information

• Verified date: March 2022
• Source: Poudre Valley Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. Investigators will compare this patient population to patients managed with upfront operation for context.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: January 3, 2023
• Est. primary completion date: January 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Penetrating neck trauma

• Carotid or vertebral artery injury

Related Conditions & MeSH terms

• Cerebrovascular Trauma

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Poudre Valley Health System	Denver Health Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patients with stroke	ischemic stroke	up to one year post-injury
Secondary	number of patients with injury progression	CTA progression of PCVI severity (Grade)	up to one year post-injury
Secondary	number of patients with death	death	up to one year post-injury
Secondary	number of patients with bleeding complications	intracranial hemorrhage, GI bleed, etc requiring change in treatment	up to one year post-injury
Secondary	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
Secondary	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