NCT01426919

Brief 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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
2,011

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2012

Longer than P75 for all trials

Geographic Reach
3 countries

24 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

First Submitted

Initial submission to the registry

August 30, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2011

Completed
1.3 years until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

December 16, 2020

Status Verified

December 1, 2020

Enrollment Period

4.6 years

First QC Date

August 30, 2011

Last Update Submit

December 11, 2020

Conditions

Traumatic Brain Injury

Keywords

Traumatic Brain InjuryHead Injury

Outcome Measures

Primary Outcomes (1)

  • Correlation of assay result with absence of acute intracranial lesions

    Day 1

Study Arms (1)

Suspected traumatic brain injury with head CT

Other: Head CT scan and blood draw within 12 hours of injury

Interventions

Head CT scan and blood draw within 12 hours of injuryOTHER
Suspected traumatic brain injury with head CT

Eligibility Criteria

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

Subjects eligible for study participation will be over the age of 18 and present to the health care facility with a head injury at a time such that sample collection can be completed within 12 hours of injury. Subjects who will be permitted into the study include those who will meet all the inclusion criteria and will have none of the exclusion criteria.

You may qualify if:

  • subject is at least 18 years of age at screening
  • suspected traumatically induced head injury as a result of insult to the head from external force
  • GCS 9-15 at time of informed consent
  • workup includes head CT scan as part of clinical emergency care within 3 hours of presenting and within 12 hours of injury
  • blood sample collected within 3 hours of presenting and within 12 hours of injury
  • subject or legal representative is willing to undergo informed consent

You may not qualify if:

  • participating in an interventional, therapeutic clinical study that may affect the results of this study (an observational study acceptable)
  • time of injury cannot be determined
  • primary diagnosis of ischemic or hemorrhagic stroke
  • venipuncture not feasible
  • a condition precluding entry into the CT scanner
  • subject has a neurodegenerative disease or other neurological disorder including dementia, Parkinson's disease, multiple sclerosis, seizure disorder, brain tumors, and history of neurosurgery, stroke or TIA within the last 30 days
  • administration of blood transfusion after head injury and prior to study blood draw
  • subject is otherwise determined by the Investigator to be unsuitable for participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

University of California San Diego

San Diego, California, 92103, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

Tallahassee Neurological Clinic

Tallahassee, Florida, 32308, United States

Location

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

Wayne State University - Detroit Receiving Hospital

Detroit, Michigan, 48201, United States

Location

Wayne State University - Sinai Grace Hospital

Detroit, Michigan, 48235, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

University Medical Center Brackenridge

Austin, Texas, 78701, United States

Location

Baylor College of Medicine/Ben Taub General Hospital

Houston, Texas, 77030, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Carilion New River Valley

Christiansburg, Virginia, 24073, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

University of Washington

Seattle, Washington, 98104, United States

Location

Charité Universitätsmedizin Berlin - Campus Benjamin Franklin

Berlin, D-12200, Germany

Location

Charité Universitätsmedizin Berlin - Campus Virchow Klinikum

Berlin, D-13353, Germany

Location

University of Heidelberg

Heidelberg, DE-69120, Germany

Location

Ludwig-Maximilians-University

Munich, DE-80336, Germany

Location

Klinikum rechts der Isar of the Technical University of Munich

Munich, DE-81675, Germany

Location

University of Pecs

Pécs, 7623, Hungary

Location

University of Szeged, Albert Szent Gyorgi Medical Center

Szeged, 6725, Hungary

Location

Related Publications (3)

  • Ward MD, Weber A, Merrill VD, Welch RD, Bazarian JJ, Christenson RH. Predictive Performance of Traumatic Brain Injury Biomarkers in High-Risk Elderly Patients. J Appl Lab Med. 2020 Jan 1;5(1):91-100. doi: 10.1093/jalm.2019.031393.

    PMID: 32445344BACKGROUND

  • Bazarian JJ, Biberthaler P, Welch RD, Lewis LM, Barzo P, Bogner-Flatz V, Gunnar Brolinson P, Buki A, Chen JY, Christenson RH, Hack D, Huff JS, Johar S, Jordan JD, Leidel BA, Lindner T, Ludington E, Okonkwo DO, Ornato J, Peacock WF, Schmidt K, Tyndall JA, Vossough A, Jagoda AS. Serum GFAP and UCH-L1 for prediction of absence of intracranial injuries on head CT (ALERT-TBI): a multicentre observational study. Lancet Neurol. 2018 Sep;17(9):782-789. doi: 10.1016/S1474-4422(18)30231-X. Epub 2018 Jul 24.

    PMID: 30054151RESULT

  • Bazarian JJ, Welch RD, Caudle K, Jeffrey CA, Chen JY, Chandran R, McCaw T, Datwyler SA, Zhang H, McQuiston B. Accuracy of a rapid glial fibrillary acidic protein/ubiquitin carboxyl-terminal hydrolase L1 test for the prediction of intracranial injuries on head computed tomography after mild traumatic brain injury. Acad Emerg Med. 2021 Nov;28(11):1308-1317. doi: 10.1111/acem.14366. Epub 2021 Sep 7.

    PMID: 34358399DERIVED

MeSH Terms

Conditions

Brain Injuries, TraumaticCraniocerebral Trauma

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Design

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

Study Record Dates

First Submitted

August 30, 2011

First Posted

September 1, 2011

Study Start

December 1, 2012

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

December 16, 2020

Record last verified: 2020-12

Locations

US(17)DE(5)HU(2)