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COMPLETED NA

A Validation of a Genomics Based Prognostic in Severe Trauma

NCT01810328 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 120 participants
Start Date 2013-10
Est. Completion 2019-07-23
Phase NA

Sponsor

University of Florida

1,066 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01810328

The ClinicalTrials.gov registry entry for NCT01810328 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Florida, which has 1,066 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01810328 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Florida, Washington. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01810328?

The interventions under investigation include: Traumatized population (OTHER), Healthy Volunteers (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01810328?

This trial is sponsored by University of Florida, which has 1,066 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial