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Longitudinal Gene Expression Profiling in Adults After Traumatic Injury

NCT02656459 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 52

Last updated 2019-03-29

No results posted yet for this study

Summary

The purpose of this study is to examine the immune response to traumatic injury and subsequent infections in critically ill adults. Traumatic injuries lead to severe dysregulation of the immune system, and predispose to severe infections. Diagnosing these infections in a timely manner is paramount in reducing morbidity and mortality, but diagnosis is made difficult by the inflammatory response to trauma. The main purpose of the study is to prospectively test the diagnostic power of the expression of an 11-gene set which the investigators recently published (Sweeney et al., Sci Transl Med, 2015). Since the timing of an acquired infection cannot be determined a priori, this study is designed to be a longitudinal examination of a cohort of traumatically injured adults. The investigators will draw blood at regular intervals, as well as at day of diagnosis of infection for any patient that are diagnosed with an infection. The investigators will then assay the blood for gene expression levels post hoc, and correlate the molecular profiles with clinical information to establish a prospective estimate of diagnostic power.

Conditions

Interventions

OTHER

11-gene set

This trial is NOT interventional. The 11-gene set / Sepsis MetaScore will be tested post-hoc.

Sponsors & Collaborators

Principal Investigators

  • Timothy E Sweeney, MD, PhD · Stanford University

  • Purvesh Khatri, PhD · Stanford University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2017-05-31
Completion
2017-08-31

Countries

  • United States
  • Germany

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02656459 on ClinicalTrials.gov