Head and Neck Trauma Registry, Protocol ID: 032.MBSI.2021.D

Recruiting

• Conditions: Craniocerebral Trauma

• Registration Number: NCT05592899
• Lead Sponsor: Methodist Health System

Brief Summary

This is a retrospective registry dataset of all adults who presented with cervical and/or skull base fractures or a subdural hematoma at Methodist Dallas Medical Center (MDMC) and had consults to the neurological surgery department beginning in January of 2016, and continuing until a statistically significant number of cases are obtained.

Detailed Description

This is a retrospective registry dataset of all adults who presented with cervical and/or skull base fractures or a subdural hematoma at Methodist Dallas Medical Center (MDMC) and had consults to the neurological surgery department beginning in January of 2016, and continuing until a statistically significant number of cases are obtained. Subjects will undergo no additional tests or procedures as part of this registry study. All patient data will be obtained from the patient's electronic health records of the hospital or clinic in a retrospective manner. The process for gathering the data will not influence treatment decisions. There will be no direct patient contact associated with inclusion in this registry study.

Study Timeline

• Study Start: 2021-08-23
• Study First Submitted: 2022-02-03
• Study First Submitted QC: 2022-10-21
• Study First Posted: 2022-10-25
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-26
• Last Update Posted: 2024-03-27
• Primary Completion: 2024-08-23
• Study Completion: 2024-08-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients 18 years of age or older
• Presenting to MDMC with cervical and/or skull base fractures or those with subdural hematomas

Exclusion Criteria

• Do not meet the Study Inclusion Criteria laid out in section 4.1.
• Vulnerable populations

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Collection of data for the Head and Neck Trauma Registry: mechanism of injury, arterial injury, skeletal injury	Jan 2018 to Dec 2022	mechanism of injury, arterial injury, skeletal injury
Collection of data for the Head and Neck Trauma Registry: traumatic diagnosis	Jan 2018 to Dec 2022	traumatic diagnosis
Collection of data for the Head and Neck Trauma Registry: disease course, treatment course, hospital course, treatment responses	Jan 2018 to Dec 2022	disease course, treatment course, hospital course, treatment responses
Collection of data for the Head and Neck Trauma Registry: reoperation rates for the same diagnosis	Jan 2018 to Dec 2022	reoperation rates for the same diagnosis
Collection of data for the Head and Neck Trauma Registry: surgical and non-surgical outcomes	Jan 2018 to Dec 2022	surgical and non-surgical outcomes
Collection of data for the Head and Neck Trauma Registry: Patient Demographics	Jan 2018 to Dec 2022	To collect clinical data related to patient demographics
Collection of data for the Head and Neck Trauma Registry: radiographic modality and findings	Jan 2018 to Dec 2022	radiographic modality and findings
Collection of data for the Head and Neck Trauma Registry: surgical management	Jan 2018 to Dec 2022	surgical management (endovascular, open, none)

Trial Locations

Locations (1)

Methodist Moody Brain and Spine Institute, Methodist Dallas Medical Center; 🇺🇸 Dallas, Texas, United States