Completed

TSFIValidation of Trauma Specific Frailty Index in Geriatric Trauma Patients

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Study Aim

This study aims to observe and validate the Trauma Specific Frailty Index by focusing on treatment-related complications and mortality in geriatric trauma patients.

What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Wounds and Injuries

Over 65 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Only

Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.
Observational
Study Start: September 2019
See protocol details

Summary

Principal SponsorMethodist Health System
Last updated: March 25, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 20, 2019

Actual date on which the first participant was enrolled.

The study focuses on the geriatric population, specifically those who have experienced trauma, as they are the fastest growing age group in the U.S and are at high risk of developing complications. Frailty, a condition of reduced resistance to stressors due to a decline in physiological reserves, is a major health burden in older people and is associated with adverse health outcomes. The Trauma Specific Frailty Index (TSFI) was developed to predict the presence of frailty and pre-frailty syndrome in geriatric trauma patients. This study aims to validate the TSFI on a large scale, across multiple institutions, to improve care and address current challenges for geriatric trauma patients. In this observational study, Methodist Dallas Medical Center (MDMC) will participate as a site contributing to the multi-center study led by Dr. Bellal at the University of Arizona. At MDMC, Dr. Amos will serve as the site-PI. The study will monitor participants for complications associated with treatment and will also track mortality rates. The TSFI, which consists of 15 variables, will be used to predict adverse discharge dispositions, such as mortality or discharge to a skilled nursing facility, as well as adverse complications and failure to rescue among geriatric trauma patients.

Official TitleMulti-Institutional Validation of Trauma Specific Frailty Index
NCT04216381
Principal SponsorMethodist Health System
Last updated: March 25, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

500 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-only

These studies focus only on individuals who have a specific disease. Researchers examine patterns—often genetic or environmental—to uncover what might be linked to the condition.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Wounds and Injuries

Criteria

2 inclusion criteria required to participate
Age >= 65 years

Diagnosis of physical trauma

2 exclusion criteria prevent from participating
Refusal of consent

Non-responsive patients who are unable to consent with no relative/proxy available to consent

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Methodist Dallas Medical Center

Dallas, United StatesOpen Methodist Dallas Medical Center in Google Maps
CompletedOne Study Center