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

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.

Study Overview

• Status: Recruiting
• Conditions: Craniocerebral Trauma

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 Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Crystee Cooper, DHEd; Phone Number: 214-947-1280; Email: ClinicalResearch@mhd.com
• Study Contact Backup: Name: Zaid Haddadin, MS; Phone Number: 214-947-1280; Email: clinicalresearch@mhd.com

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75203
      • Recruiting
      • Methodist Moody Brain and Spine Institute, Methodist Dallas Medical Center
      • Principal Investigator: Richard Meyrat, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Collection of data for the Head and Neck Trauma Registry: traumatic diagnosis	traumatic diagnosis	Jan 2018 to Dec 2022
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
Collection of data for the Head and Neck Trauma Registry: radiographic modality and findings	radiographic modality and findings	Jan 2018 to Dec 2022
Collection of data for the Head and Neck Trauma Registry: surgical management	surgical management (endovascular, open, none)	Jan 2018 to Dec 2022
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
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
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

Collaborators and Investigators

• Sponsor: Methodist Health System
• Investigators: Principal Investigator: Michael Oh, MD, PhD, Methodist

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2021
• Primary Completion (Estimated): August 23, 2024
• Study Completion (Estimated): August 23, 2024

Study Registration Dates

• First Submitted: February 3, 2022
• First Submitted That Met QC Criteria: October 21, 2022
• First Posted (Actual): October 25, 2022

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Craniocerebral Trauma
• Other Study ID Numbers: 032.MBSI.2021.D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No