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NCT01810328 · ClinicalTrials.gov registry record · NA
A Validation of a Genomics Based Prognostic in Severe Trauma
A NA study of Multiple Organ Failure and Trauma; Complications, sponsored by University of Florida.
- Completed
- Registry status
- NA
- Development phase
- 120
- Enrollment target
- 2
- Study locations
NCT01810328: Completed NA study of Multiple Organ Failure and Trauma; Complications, sponsored by University of Florida.
NCT01810328 is a NA study of Multiple Organ Failure and Trauma; Complications that has completed, run by University of Florida. The registered enrollment target is 120 participants, below the 11,643-participant average among 3 other Multiple Organ Failure trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01810328, a NA study of Multiple Organ Failure and Trauma; Complications, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- NA
- Development phase
- 120 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
A genomic score will be derived and assessed for each patient from the first two blood collections. A threshold score will be generated prior to the study initiation that will be used to statistically assign patients to either a "complicated outcome" or "other outcome", with primary goal being to identify severe trauma patients who are likely to have a complicated clinical course.
Conditions Studied
Interventions
- OTHER Traumatized population
- OTHER Healthy Volunteers
Study Locations (2)
Florida
- UF Laboratory of Inflammation Biology and Surgical Science and Shands Hospital at UF - Gainesville
Washington
- UW Harborview Research and Training Building - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2013-10 |
| Est. Completion | 2019-07-23 |
| Phase | NA |
What the finished NCT01810328 record still lists
NCT01810328 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 11,643-participant average among 3 other Multiple Organ Failure trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Multiple Organ Failure appearing as the primary indexed condition, and to 2 interventions - of which Traumatized population is the first listed.
NCT01810328 reports a single indexed study location in Florida, Washington.
Frequently Asked Questions
What is clinical trial NCT01810328 about?
NCT01810328 is a clinical study titled "A Validation of a Genomics Based Prognostic in Severe Trauma". 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 st...
What is the current status of trial NCT01810328?
This trial is currently completed. It is a NA study. The enrollment target is 120 participants. The study started on 2013-10. Estimated completion is 2019-07-23.
What conditions does trial NCT01810328 study?
This clinical trial studies the following conditions: Multiple Organ Failure, Trauma; Complications.
What interventions are being tested in trial NCT01810328?
The interventions under investigation include: Traumatized population (OTHER), Healthy Volunteers (OTHER).
Who is sponsoring clinical trial NCT01810328?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01810328 being conducted?
This trial has 2 study locations across Florida, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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