NCT07492758

Brief Summary

The primary objective of this study is to establish a data set that will be permissive of quality improvement studies/observations specific to life and limb salvage in comprisable extremity injuries.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
999

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2023

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

October 31, 2023

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 14, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2025

Completed
10 months until next milestone

First Posted

Study publicly available on registry

March 25, 2026

Completed
Last Updated

March 25, 2026

Status Verified

October 1, 2024

Enrollment Period

1.6 years

First QC Date

November 14, 2024

Last Update Submit

March 19, 2026

Conditions

Trauma

Outcome Measures

Primary Outcomes (1)

  • establish a data set that will be permissive of quality improvement studies/observations specific to life and limb salvage in comprisable extremity injuries.

    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

Interventions

Non-Interventional (Registry)OTHER

Non-Interventional (Registry)

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • \<16 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Institute at Methodist Health System

Dallas, Texas, 75203, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Registries

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesRecordsOrganization and AdministrationHealth Services AdministrationHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Conner McDaniel, MD

    Methodist Heath System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2024

First Posted

March 25, 2026

Study Start

October 31, 2023

Primary Completion

June 12, 2025

Study Completion

June 12, 2025

Last Updated

March 25, 2026

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)