- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02656459
Longitudinal Gene Expression Profiling in Adults After Traumatic Injury
Study Overview
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Essen, Germany, 45147
- University Hospital Essen
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Gottingen, Germany
- University of Gottigen
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California
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Stanford, California, United States, 94305
- Stanford University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
11-gene set / Sepsis MetaScore
Time Frame: Patients with infections will be compared to time-matched patients without infections (+/- 24 hours).
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Time-matched controls are necessary to prevent bias due to changes over time that occur with recovery from injury.
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Patients with infections will be compared to time-matched patients without infections (+/- 24 hours).
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Timothy E Sweeney, MD, PhD, Stanford University
- Principal Investigator: Purvesh Khatri, PhD, Stanford University
Publications and helpful links
General Publications
- Sweeney TE, Shidham A, Wong HR, Khatri P. A comprehensive time-course-based multicohort analysis of sepsis and sterile inflammation reveals a robust diagnostic gene set. Sci Transl Med. 2015 May 13;7(287):287ra71. doi: 10.1126/scitranslmed.aaa5993.
- Sweeney TE, Khatri P. Comprehensive Validation of the FAIM3:PLAC8 Ratio in Time-matched Public Gene Expression Data. Am J Respir Crit Care Med. 2015 Nov 15;192(10):1260-1. doi: 10.1164/rccm.201507-1321LE. No abstract available.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-35447
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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