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Evaluation of Biomarkers of Traumatic Brain Injury

NCT01426919 · View on ClinicalTrials.gov ↗

Study Summary

The primary objective of this study is to evaluate the utility of the Banyan UCH-L1/GFAP Detection Assay as an aid in the evaluation of suspected traumatic brain injury (Glasgow Coma Scale score 9-15) in conjunction with other clinical information within 12 hours of injury to assist in determining the need for a CT scan of the head.

Conditions Studied

Interventions

  • OTHER Head CT scan and blood draw within 12 hours of injury

Study Locations (20)

Virginia

  • University of Virginia — Charlottesville
  • Carilion New River Valley — Christiansburg
  • Virginia Commonwealth University — Richmond

Other

  • Charité Universitätsmedizin Berlin - Campus Benjamin Franklin — Berlin
  • Charité Universitätsmedizin Berlin - Campus Virchow Klinikum — Berlin
  • University of Heidelberg — Heidelberg

Florida

  • University of Florida — Gainesville
  • Tallahassee Neurological Clinic — Tallahassee

Michigan

  • Wayne State University - Detroit Receiving Hospital — Detroit
  • Wayne State University - Sinai Grace Hospital — Detroit

Texas

  • University Medical Center Brackenridge — Austin
  • Baylor College of Medicine/Ben Taub General Hospital — Houston

California

  • University of California San Diego — San Diego

Connecticut

  • Hartford Hospital — Hartford

Massachusetts

  • University of Massachusetts Medical School — Worcester

Trial Details

FieldValue
Enrollment Target 2,011 participants
Start Date 2012-12
Est. Completion 2017-07

Sponsor

Banyan Biomarkers

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01426919

The ClinicalTrials.gov registry entry for NCT01426919 describes a study currently listed as completed. It is categorized as an unspecified phase, 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 2,011 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Banyan Biomarkers, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Traumatic Brain Injury appearing as the primary indexed condition, and to 1 intervention — of which Head CT scan and blood draw within 12 hours of injury 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: NCT01426919 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Virginia, Other, Florida. 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 NCT01426919 about?

NCT01426919 is a clinical study titled "Evaluation of Biomarkers of Traumatic Brain Injury". The primary objective of this study is to evaluate the utility of the Banyan UCH-L1/GFAP Detection Assay as an aid in the evaluation of suspected traumatic brain injury (Glasgow Coma Scale score 9-15) in conjunction with other clinical information within 12 hours of injury to assist in determining t...

What is the current status of trial NCT01426919?

This trial is currently completed. The enrollment target is 2,011 participants. The study started on 2012-12. Estimated completion is 2017-07.

What conditions does trial NCT01426919 study?

This clinical trial studies the following conditions: Traumatic Brain Injury. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01426919?

The interventions under investigation include: Head CT scan and blood draw within 12 hours of injury (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01426919?

This trial is sponsored by Banyan Biomarkers, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01426919 being conducted?

This trial has 20 study locations across California, Connecticut, Florida, Massachusetts, Michigan. 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