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Completed

NCT Number: NCT05171010

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

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.

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥40
  • CT-verified TBI

Exclusion criteria

  • Any other body region injury AIS >2
  • Presentation at enrolling center >24 hours after injury
  • Pregnant women
  • Prisoners

Treatment and study plan

no study-based therapeutic interventions

Other

no study-based therapeutic interventions

Primary outcomes

  1. CT scan

    Time frame: "through study completion, an average of 1 year".

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

Secondary outcomes

  1. Comorbidities

    Time frame: "through study completion, an average of 1 year".

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

Sponsors and collaborators

Lead sponsor

Methodist Health System

Other

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Dec 28, 2021
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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