NCT05171010

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

November 29, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2020

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

December 28, 2021

Completed
Last Updated

March 24, 2026

Status Verified

February 1, 2024

Enrollment Period

2.8 years

First QC Date

September 22, 2020

Last Update Submit

March 20, 2026

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Comorbidities

    "through study completion, an average of 1 year".

Interventions

no study-based therapeutic interventionsOTHER

no study-based therapeutic interventions

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Geriatric patients with TBI

You may qualify if:

  • Age ≥40
  • CT-verified TBI

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Michael Truitt, MD

    The Methodist Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2020

First Posted

December 28, 2021

Study Start

November 29, 2017

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

March 24, 2026

Record last verified: 2024-02

Locations

US(1)