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Longitudinal Gene Expression Profiling in Adults After Traumatic Injury

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ClinicalTrials.gov Identifier: NCT02656459
Recruitment Status : Completed
First Posted : January 15, 2016
Last Update Posted : March 29, 2019
Sponsor:
Collaborator:
University Medical Center Goettingen
Information provided by (Responsible Party):
Stanford University

Brief 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.

Condition or disease Intervention/treatment
Sepsis Trauma Infection Other: 11-gene set

Detailed Description:

Consecutive patients who meet criteria (see below) will be enrolled. Whole blood will be drawn and stored in PAXgene tubes. Blood will be drawn within 24 hours of ICU admission (ICU day 1), and then every three days subsequently (ICU days 4, 7, 10, 13) for two weeks. In addition, a tube of blood will be drawn at the time of clinical diagnosis of infection, if an infection is diagnosed (see below). Patients who are discharged from the ICU prior to two weeks will no longer be profiled. The hour and date of admission, and the hour and date of each subsequent blood draw, will be recorded.

Rates of hospital-acquired infection after severe traumatic injury run around 30-50%. The investigators will enroll 50 patients, which should net around 20 patients with infections, and 30 time-matched non-infected controls. In total, an average of 4 samples/patient, or 200 total blood samples, are expected.

Diagnosis of Infection:

The main purpose of the study is to examine gene expression response to infections. As a result, careful attention must be paid to how infections are classified. First, two systemic inflammatory reaction syndrome (SIRS) criteria are NOT necessary to be designated as infected. Second, the time of diagnosis of infection (and the time of extra blood sampling) will be the time of clinical diagnosis, not the later time that cultures turn positive. It will thus be based on clinical judgement. Finally, post-hoc criteria for infections are described elsewhere. Patients need to eventually meet these criteria to be counted as infected; this will be done in the analysis phase, not the clinical phase.


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Study Type : Observational
Actual Enrollment : 52 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Longitudinal Gene Expression Profiling in Adults After Traumatic Injury
Study Start Date : January 2016
Actual Primary Completion Date : May 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: 11-gene set
    This trial is NOT interventional. The 11-gene set / Sepsis MetaScore will be tested post-hoc.
    Other Name: Sepsis MetaScore


Primary Outcome Measures :
  1. 11-gene set / Sepsis MetaScore [ Time Frame: Patients with infections will be compared to time-matched patients without infections (+/- 24 hours). ]
    Time-matched controls are necessary to prevent bias due to changes over time that occur with recovery from injury.


Biospecimen Retention:   Samples Without DNA
Whole blood RNA specimens will be retained up to 3 years after study end.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
No patients will be enrolled at Stanford. All enrollment will be done at Universitätsmedizin Göttingen. ICU admissions will be reviewed by the local research team; all patients admitted for blunt trauma will then be screened by chart review for matching inclusion/exclusion criteria.
Criteria

Inclusion Criteria:

  • Consecutive adults (>=18 years old) admitted to the ICU after blunt traumatic injury.

Exclusion Criteria:

  • Patients with isolated traumatic head or spinal cord injuries will not be included.
  • Furthermore, patients with prior or under continuous antibiotic therapy will be excluded (e.g. in case of intestinal perforation).
  • We will not exclude patients who are given <=24 hours of perioperative antibiotics.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02656459


Locations
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United States, California
Stanford University
Stanford, California, United States, 94305
Germany
University Hospital Essen
Essen, Germany, 45147
University of Gottigen
Gottingen, Germany
Sponsors and Collaborators
Stanford University
University Medical Center Goettingen
Investigators
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Principal Investigator: Timothy E Sweeney, MD, PhD Stanford University
Principal Investigator: Purvesh Khatri, PhD Stanford University

Publications:
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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT02656459     History of Changes
Other Study ID Numbers: IRB-35447
First Posted: January 15, 2016    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: March 2019

Keywords provided by Stanford University:
gene expression

Additional relevant MeSH terms:
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Wounds and Injuries