Clinical trial NCT05592899: Head and Neck Trauma Registry, Protocol ID: 032.MBSI.2021.D
Official title: Head and Neck Trauma Registry, Protocol ID: 032.MBSI.2021.D
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Craniocerebral Trauma
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2022-10-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Patients 18 years of age or older
* Presenting to MDMC with cervical and/or skull base fractures or those with subdural hematomas

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.

Eligibility criteria: 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

Primary outcomes:
measure: Collection of data for the Head and Neck Trauma Registry: Patient Demographics
timeFrame: Jan 2018 to Dec 2022
measure: Collection of data for the Head and Neck Trauma Registry: traumatic diagnosis
timeFrame: Jan 2018 to Dec 2022
measure: Collection of data for the Head and Neck Trauma Registry: mechanism of injury, arterial injury, skeletal injury
timeFrame: Jan 2018 to Dec 2022
measure: Collection of data for the Head and Neck Trauma Registry: radiographic modality and findings
timeFrame: Jan 2018 to Dec 2022
measure: Collection of data for the Head and Neck Trauma Registry: surgical management
timeFrame: Jan 2018 to Dec 2022
measure: Collection of data for the Head and Neck Trauma Registry: disease course, treatment course, hospital course, treatment responses
timeFrame: Jan 2018 to Dec 2022
measure: Collection of data for the Head and Neck Trauma Registry: surgical and non-surgical outcomes
timeFrame: Jan 2018 to Dec 2022
measure: Collection of data for the Head and Neck Trauma Registry: reoperation rates for the same diagnosis
timeFrame: Jan 2018 to Dec 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Moody Brain and Spine Institute, Methodist Dallas Medical Center
state: Texas
Study officials:
affiliation: Methodist
name: Michael Oh, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: