Geri-TBI: A Prospective Multi-center Evaluation of Geriatric Patients With Traumatic Brain Injury

• Sponsor: Methodist Health System (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05171010
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Anticipated Duration (Months): 59.1
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

This multicenter prospective observational study is designed to prospectively record data on patients who are managed per institutional standard of care. The objectives of this study are to establish an aggregate database of information on baseline clinical and demographic characteristics, medication use, markers of frailty, injury characteristics, management strategies, and outcomes following TBI in geriatric patients, determine best practices for management of geriatric patients with TBI, and establish how markers of frailty correlate with outcome in geriatric patients with TBI.

Condition or Disease	Intervention/Treatment	Phase
Traumatic Brain Injury	Other: no study-based therapeutic interventions

Detailed Description

This is a prospective multi-center observational study of geriatric patients with TBI. Data collected will be purely observational and involve no study-based therapeutic interventions or alterations in patient care. Due to the purpose of this study being the creation of a registry and the absence of demographic information being collected, all patients meeting the inclusion criteria will be enrolled without informed consent. We plan to complete the data collection and analysis by 12/31/2018.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 60 participants
• Observational Model: Other
• Time Perspective: Retrospective
• Official Title: Geri-TBI: A Prospective Multi-center Evaluation of Geriatric Patients With Traumatic Brain Injury
• Actual Study Start Date: Nov 29, 2017
• Anticipated Primary Completion Date: Nov 1, 2022
• Anticipated Study Completion Date: Nov 1, 2022

Outcome Measures

Primary Outcome Measures

1. CT scan ["through study completion, an average of 1 year".]

   CT scan-verified traumatic brain injury in patients aged greater than or equal to 40

Secondary Outcome Measures

1. Comorbidities ["through study completion, an average of 1 year".]

   history of any systemic diseases like diabetes, hypertension, blood pressure

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age ≥40

• CT-verified TBI

Exclusion Criteria:

1. Any other body region injury AIS >2

2. Presentation at enrolling center >24 hours after injury

3. Pregnant women

4. Prisoners

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Methodist Dallas Medical Center	Dallas	Texas	United States	75203

Sponsors and Collaborators

• Methodist Health System

Investigators

• Principal Investigator: Michael Truitt, MD, Methodist Dallas Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Methodist Health System
• ClinicalTrials.gov Identifier: NCT05171010
• Other Study ID Numbers: 049.GME.2017.D
• First Posted: Dec 28, 2021
• Last Update Posted: Dec 28, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Additional relevant MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries

Study Results

No Results Posted as of Dec 28, 2021