A Validation of a Genomics Based Prognostic in Severe Trauma

Summary

The purpose of this study is to learn more about how to treat patients with severe injuries related to trauma and to prevent failure of vital organs in this patient population. Approximately 200 severely injured patients with blunt trauma and 40 healthy volunteer subjects will be enrolled in this study. During the study seven blood samples (4-5 mls) will be collected from patients who have suffered severe trauma over a 28 day period. A one time 5 ml blood sample will be collected from the healthy volunteers. Clinical data will be collected daily while patients are hospitalized. The initial blood sample must be collected from qualifying patients within the first 12 hours of admission to the hospital. The reason for blood sampling is to validate a rapid genomic test in real time. Once confirmed, this genomic test can be used to identify patients who will have a complicated clinical course and would, therefore, be good candidates for interventional, immunomodulatory therapies.

Conditions

• Trauma; Complications
• Multiple Organ Failure

Interventions

OTHER

Traumatized population

In the traumatized population (severe blunt traumatic injury), blood samples will be collected at admission, days 1, 4, 7, 14, 21 and 28, or until discharge from the ICU or death. A total of 5 mLs of blood will be collected at admission and day 1, 4 mLs of blood will be collected at each remaining time point.

OTHER

Healthy Volunteers

The healthy volunteer participants will donate a one-time 5 mL blood sample which will undergo rapid leukocyte genomic screening. These controls will allow the investigators to determine if the values obtained are accurate, reliable, and repeatable.

Sponsors & Collaborators

• National Institutes of Health (NIH)

  collaborator NIH

• National Institute of General Medical Sciences (NIGMS)

  collaborator NIH

• Massachusetts General Hospital

  collaborator OTHER

• University of Florida

  lead OTHER

Principal Investigators

• Lyle L Moldawer, Ph.D. · University of Florida

• Ronald Maier, M.D. · University of Washington

Study Design

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2013-10-31

Primary Completion

2016-11-30

Completion

2019-07-23

Countries

• United States

Study Locations