NCT02011412

Brief Summary

The investigators hypothesize that a risk score composed of age, sex, and the components of commonly ordered laboratory panels will be predictive of mortality in trauma patients, and will help improve clinicians' ability to make more accurate mortality predictions at the time of admission.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2013

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

October 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 6, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 13, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 24, 2016

Status Verified

February 1, 2016

Enrollment Period

2.2 years

First QC Date

November 6, 2013

Last Update Submit

February 22, 2016

Conditions

Keywords

TraumaScoring SystemsIntermountain Risk Score

Outcome Measures

Primary Outcomes (2)

  • all cause mortality

    To determine whether the Intermountain Risk Score accurately predicts 30 day mortality and one year mortality in trauma patients.

    30 days

  • all cause mortality

    measure the ability of the Intermountain Risk Score to predict all cause mortality at one year after the traumatic event

    1 year

Secondary Outcomes (2)

  • experienced clinicians mortality prediction

    30 days

  • Experienced Clinicians' mortality prediction

    1 year

Study Arms (2)

Intermountain Risk Score known

Intermountain Risk Score Unknown

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals who suffer from a traumatic injury and present to the Emergency Department as a Trauma Activation

You may qualify if:

  • Patient presents to Intermountain Medical Center as a Level I or Level II trauma activation.
  • Age ≥18

You may not qualify if:

  • Patients who are not admitted to the hospital
  • Patients who expire in the Emergency Department
  • Patients who are discharged to home from the Emergency Department
  • Patients who do not have a complete blood count and basic metabolic profile drawn in the Emergency Department as part of routine clinical care.
  • Patients who enter the hospital as "trauma consults." These patients have traumatic injuries, and are often admitted to the trauma service, but the severity of their trauma is not thought to warrant trauma team activation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Sarah Majercik MD, MBA, FACS, Division of Trauma and Surgical Critical Care

Study Record Dates

First Submitted

November 6, 2013

First Posted

December 13, 2013

Study Start

October 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

February 24, 2016

Record last verified: 2016-02

Locations