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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05592899

Enrollment

Registered

2022-10-25

Start date

2021-08-23

Completion date

2024-08-23

Last updated

2024-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Craniocerebral Trauma

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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: traumatic diagnosis	Jan 2018 to Dec 2022	traumatic diagnosis
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: 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)
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: 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: reoperation rates for the same diagnosis	Jan 2018 to Dec 2022	reoperation rates for the same diagnosis

Countries

United States

Contacts

Primary ContactCrystee Cooper, DHEd

clinicalresearch@mhd.com214-947-1280

Backup ContactZaid Haddadin, MS