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NCT02656459 · ClinicalTrials.gov registry record
Longitudinal Gene Expression Profiling in Adults After Traumatic Injury
A clinical trial of Sepsis and Trauma, sponsored by Stanford University.
- Completed
- Registry status
- 52
- Enrollment target
- 3
- Study locations
NCT02656459: Completed study of Sepsis and Trauma, sponsored by Stanford University.
NCT02656459 is a study of Sepsis and Trauma that has completed, run by Stanford University. The registered enrollment target is 52 participants, below the 6,564-participant average among 90 other Sepsis trials with a reported enrollment target (99% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02656459, a study of Sepsis and Trauma, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- 52 participants
- Enrollment target
- 3
- Study locations
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.
Primary Outcome
Time-matched controls are necessary to prevent bias due to changes over time that occur with recovery from injury.
Interventions
- OTHER 11-gene set
Study Locations (3)
Other
- University Hospital Essen - Essen
- University of Gottigen - Göttingen
California
- Stanford University - Stanford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2016-01 |
| Est. Completion | 2017-08 |
What the finished NCT02656459 record still lists
NCT02656459 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 6,564-participant average among 90 other Sepsis trials with a reported enrollment target (99% lower).
The record links to 3 conditions, with Sepsis appearing as the primary indexed condition, and to 1 intervention - of which 11-gene set is the first listed.
NCT02656459 reports a single indexed study location in Other, California.
Frequently Asked Questions
What is clinical trial NCT02656459 about?
NCT02656459 is a clinical study titled "Longitudinal Gene Expression Profiling in Adults After Traumatic Injury". 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 i...
What is the current status of trial NCT02656459?
This trial is currently completed. The enrollment target is 52 participants. The study started on 2016-01. Estimated completion is 2017-08.
What conditions does trial NCT02656459 study?
This clinical trial studies the following conditions: Sepsis, Trauma, Infection.
What interventions are being tested in trial NCT02656459?
The interventions under investigation include: 11-gene set (OTHER).
Who is sponsoring clinical trial NCT02656459?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02656459 being conducted?
This trial has 3 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02656459's enrollment target sits among peer trials
52 71st of 90 higher than 20 of 90 other Sepsis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sepsis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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