Skip to main content
OpenTrials
Completed

NCT Number: NCT01295346

Biomarkers of Mild and Moderate Traumatic Brain Injury

The purpose of this study is to assess if putative brain injury biomarkers have utility as blood-based traumatic brain injury (TBI) diagnostic and monitoring tools. This will be accomplished by examining the relationships between potential serum-based TBI biomarkers and clinical measures of injury severity, occurrence of complications, and outcome, in subjects with mild or moderate TBI. The assay will be evaluated in a sample population of subjects over the age of 18 who have been referred to the health care provider for closed head injury evaluation.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Brain Injuries, Traumatic Brain Diseases Brain Injuries Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Pecs, Pécs, Hungary

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least 18 years of age and no more than 80 years of age.
  • Closed injury to the head within 4 hours from symptom onset.
  • Glasgow Coma Scale (GCS) Score of 9-15.
  • Head Computerized Tomography (CT) performed as part of routine care.
  • Subject is willing to undergo the Informed Consent process prior to enrollment.
  • Based upon the Principal Investigator's opinion, subject is an appropriate candidate for the study.

Exclusion criteria

  • Participating in another clinical study that may affect the results of either study.
  • Time of injury cannot be determined.
  • Head CT not done as part of clinical emergency care.
  • Primary diagnosis of ischemic or hemorrhagic infarct.
  • Not available for 35 day follow-up visit.
  • Venipuncture not feasible.
  • Blood donation within 1 week of screening.
  • The Subject is otherwise determined by the Investigator to be medically unsuitable for participation in this study.

Treatment and study plan

Head CT scan and blood draw

Other

Primary outcomes

  1. Assessment of putative TBI markers relative to diagnosis

    Time frame: within 24 hours and at Day 35

Secondary outcomes

  1. Assessment of correlation between putative TBI marker levels and severity of TBI and neuropsychological outcome (per RPQ and ImPACT)

    Time frame: within 24 hours and at Day 35

Other outcomes

  1. Assessment of pituitary status and determination of the presence of autoantibodies

    Time frame: Day 35

Sponsors and collaborators

Lead sponsor

Banyan Biomarkers, Inc

Industry

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 14, 2011
Registry last updated
Aug 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.