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

Craniocerebral Trauma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05592899
• Other study ID #: 032.MBSI.2021.D
• Status: Recruiting
• Start date: August 23, 2021
• Est. completion date: August 23, 2024

Study information

• Verified date: March 2024
• Source: Methodist Health System
• Contact: Crystee Cooper, DHEd
• Phone: 214-947-1280
• Email: clinicalresearch[@]mhd.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 23, 2024
• Est. primary completion date: August 23, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Craniocerebral Trauma
• Wounds and Injuries

Locations

Country	Name	City	State
United States	Methodist Moody Brain and Spine Institute, Methodist Dallas Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome

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