Natural History and Nonoperative Management of Penetrating Cerebrovascular Injury

NCT05305690 | Unknown

• 1 other identifier: 19-0647
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cerebrovascular Trauma

Keywords

penetrating cerebrovascular injury; nonoperative management; penetrating neck trauma; natural history; antithrombotic therapy; case series

Outcome Measures

Primary Outcomes (1)

• number of patients with stroke

  ischemic stroke

  up to one year post-injury

Secondary Outcomes (5)

• number of patients with injury progression

  up to one year post-injury

• number of patients with death

  up to one year post-injury

• number of patients with bleeding complications

  up to one year post-injury

• number of patients treated with operative exploration

  up to one year post-injury

• number of patients treated with arterial embolization or arterial stent placement

  up to one year post-injury

Study Arms (2)

Penetrating cerebrovascular injury, managed nonoperatively

PCVI from penetrating trauma without upfront operation

Other: No intervention

Penetrating cerebrovascular injury, managed operatively

Other: No intervention

Interventions

No intervention OTHER

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 nonoperatively; Penetrating cerebrovascular injury, managed operatively

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Penetrating neck trauma
• Carotid or vertebral artery injury

Sponsors & Collaborators

• Poudre Valley Health System: lead
• Denver Health Medical Center: collaborator

MeSH Terms

Conditions

Cerebrovascular Trauma

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: February 25, 2022
• First Posted: March 31, 2022
• Study Start: May 1, 2016
• Primary Completion: January 3, 2023
• Study Completion: January 3, 2023
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share