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NCT05171010 Clinical Trial

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

Traumatic Brain Injury Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05171010
Other study ID # 049.GME.2017.D
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 29, 2017
Est. completion date September 1, 2020

Study information
Verified date February 2024
Source Methodist Health System
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 69
Est. completion date September 1, 2020
Est. primary completion date September 1, 2020
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• no study-based therapeutic interventions
no study-based therapeutic interventions

Locations
Country Name City State
United States Methodist Dallas Medical Center Dallas Texas

Sponsors (1)
Lead Sponsor Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary CT scan CT scan-verified traumatic brain injury in patients aged greater than or equal to 40 "through study completion, an average of 1 year".
Secondary Comorbidities history of any systemic diseases like diabetes, hypertension, blood pressure "through study completion, an average of 1 year".
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