Non-Interventional (Registry) in Trauma - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Trauma

Intervention / Treatment

Other: Non-Interventional (Registry)

Detailed Description

Tourniquets are often overused. Direct pressure should be the first step in STB. Combat dressings allow for hands free pressure. These data could provide a foundation for pre-hospital process improvement studies.

This data repository will serve as a means to aggregate and analyze best practices related to trauma patients with extremity injuries. Specific interest will be placed in best practices of the emergency medical service and trauma bay, use of tourniquets and compression bandages, ischemic injuries, and limb salvage.

Study Type

Observational

Enrollment (Actual)

999

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Texas
  - Dallas, Texas, United States, 75203
    - Clinical Research Institute at Methodist Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult trauma patients; defined by the American College of Surgeons as individuals age: ≥16 years, identified in the MDMC trauma registry with documented extremity injury.

Description

Inclusion Criteria:

Adult trauma patients; defined by the American College of Surgeons as individuals age: ≥16 years
Included in the MDMC trauma registry
Documented extremity injury

Exclusion Criteria:

<16 years old

Study Plan

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

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
establish a data set that will be permissive of quality improvement studies/observations specific to life and limb salvage in comprisable extremity injuries. Time Frame: through study completion, up to 18 months	Trauma Registry will be queried for demographic information, admission dates, traumatic injury characteristics, inpatient outcomes, complications, consultations, resuscitation strategies, compression time to control bleeding, use of tourniquet and indications, discharge location, and mortality. Additional triage assessments, bleeding management, and in-patient timeline, will be abstracted from EPIC.	through study completion, up to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Methodist Health System

Investigators

Principal Investigator: Conner McDaniel, MD, Methodist Heath System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2023

Primary Completion (Actual)

June 12, 2025

Study Completion (Actual)

June 12, 2025

Study Registration Dates

First Submitted

November 14, 2024

First Submitted That Met QC Criteria

March 19, 2026

First Posted (Actual)

March 25, 2026

Study Record Updates

Last Update Posted (Actual)