Head and Neck Trauma Registry, Protocol ID: 032.MBSI.2021.D
1 other identifier
observational
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 23, 2021
CompletedFirst Submitted
Initial submission to the registry
February 3, 2022
CompletedFirst Posted
Study publicly available on registry
October 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 23, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 23, 2024
CompletedMarch 27, 2024
March 1, 2024
3 years
February 3, 2022
March 26, 2024
Conditions
Outcome Measures
Primary Outcomes (8)
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
Eligibility Criteria
* Patients 18 years of age or older * Presenting to MDMC with cervical and/or skull base fractures or those with subdural hematomas
You may qualify if:
- Patients 18 years of age or older
- Presenting to MDMC with cervical and/or skull base fractures or those with subdural hematomas
You may not qualify if:
- Vulnerable populations
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Methodist Moody Brain and Spine Institute, Methodist Dallas Medical Center
Dallas, Texas, 75203, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Oh, MD, PhD
Methodist
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2022
First Posted
October 25, 2022
Study Start
August 23, 2021
Primary Completion
August 23, 2024
Study Completion
August 23, 2024
Last Updated
March 27, 2024
Record last verified: 2024-03