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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05171010
Enrollment
69
Registered
2021-12-28
Start date
2017-11-29
Completion date
2020-09-01
Last updated
2026-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury

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.

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.

Interventions

OTHERno study-based therapeutic interventions

no study-based therapeutic interventions

Sponsors

Methodist Health System
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
Comorbidities"through study completion, an average of 1 year".history of any systemic diseases like diabetes, hypertension, blood pressure

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORMichael Truitt, MD

The Methodist Hospital Research Institute

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026