NCT01295346

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
290

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Geographic Reach
2 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 7, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 14, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

August 8, 2017

Status Verified

August 1, 2017

Enrollment Period

1.2 years

First QC Date

February 7, 2011

Last Update Submit

August 7, 2017

Conditions

Brain Injuries, Traumatic

Outcome Measures

Primary Outcomes (1)

  • Assessment of putative TBI markers relative to diagnosis

    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)

    within 24 hours and at Day 35

Other Outcomes (1)

  • Assessment of pituitary status and determination of the presence of autoantibodies

    Day 35

Study Arms (1)

Traumatic Brain Injury

Patients who present to the health care facility with mild or moderate traumatic brain injury (Glasgow Coma Scale 9-15) within 4 hours of injury

Other: Head CT scan and blood draw

Interventions

Head CT scan and blood drawOTHER
Traumatic Brain Injury

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects who present to the health care facility with Traumatic Brain Injury (GCS 9-15) within 4 hours of injury.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Shands at University Florida Gainesville

Gainesville, Florida, 32610, United States

Location

Dekalb Medical Center

Decatur, Georgia, 30033, United States

Location

Gwinnett Medical Center

Lawrenceville, Georgia, 30045, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

University of Pecs

Pécs, Hungary

Location

University of Szeged

Szeged, Hungary

Location

Related Publications (1)

  • Welch RD, Ayaz SI, Lewis LM, Unden J, Chen JY, Mika VH, Saville B, Tyndall JA, Nash M, Buki A, Barzo P, Hack D, Tortella FC, Schmid K, Hayes RL, Vossough A, Sweriduk ST, Bazarian JJ. Ability of Serum Glial Fibrillary Acidic Protein, Ubiquitin C-Terminal Hydrolase-L1, and S100B To Differentiate Normal and Abnormal Head Computed Tomography Findings in Patients with Suspected Mild or Moderate Traumatic Brain Injury. J Neurotrauma. 2016 Jan 15;33(2):203-14. doi: 10.1089/neu.2015.4149. Epub 2015 Dec 18.

    PMID: 26467555RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood, serum, plasma

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Jackson Streeter, MD

    Banyan Biomarkers

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2011

First Posted

February 14, 2011

Study Start

January 1, 2011

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

August 8, 2017

Record last verified: 2017-08

Locations

HU(2)US(5)