NCT02439736

Brief Summary

The primary objective of this study is to evaluate Ubiquitin C-terminal Hydrolase-L1 (UCH-L1) and Glial Fibrillary Acidic Protein (GFAP) biomarker levels in a population of CT-positive subjects (as determined by an independent Neuroimaging Review Committee) presenting acutely with traumatic brain injury (Glasgow Coma Scale score 9-15).

Trial Health

90
On Track

Trial Health Score

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

Enrollment
119

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2015

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

First Submitted

Initial submission to the registry

May 7, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 12, 2015

Completed
20 days until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

August 8, 2017

Status Verified

August 1, 2017

Enrollment Period

1.4 years

First QC Date

May 7, 2015

Last Update Submit

August 7, 2017

Conditions

Traumatic Brain Injury

Keywords

Traumatic Brain InjuryHead Injury

Outcome Measures

Primary Outcomes (1)

  • Correlation of assay results with presence of acute intracranial lesions

    Day 1

Study Arms (1)

CT positive for acute intracranial lesion

Other: Blood draw within 12 hours of head injury

Interventions

Blood draw within 12 hours of head injuryOTHER
CT positive for acute intracranial lesion

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 with a standard of care head CT that has been confirmed to be CT-positive for acute intracranial lesions based on the local neuroradiologist's review and can undergo blood draw within 12 hours of head 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:

  • The Subject is at least 18 years of age at screening.
  • The Subject has presented to a Health Care Facility (HCF) or Emergency Department (ED) with a suspected traumatically induced head injury, as a result of insult to the head from an external force.
  • A Glasgow Coma Scale score of 9-15 at the time of Informed Consent.
  • The subject is CT-positive for acute intracranial lesion(s) based on the local neuroradiologist's review of the subject's head CT scan.
  • The CT scan and CT report used to determine eligibility must be available.
  • The blood sample is collected as close to the time of head injury as possible, but no later than 12 hours.
  • The Subject or their legal representative is willing to undergo the Informed Consent process prior to enrollment into this study

You may not qualify if:

  • Participating in an interventional, therapeutic clinical study that may affect the results of this study (an observational study would be acceptable).
  • Time of injury cannot be determined.
  • Primary diagnosis of ischemic or hemorrhagic stroke.
  • Venipuncture not feasible (i.e., skin integrity compromised at the venipuncture sites, blood vessel calcification (i.e., IV drug users, advanced atherosclerosis) both upper limbs missing (congenital or amputee)).
  • The subject has a neurodegenerative disease or other neurological disorder including dementia, Parkinson's disease, multiple sclerosis, seizure disorder, or brain tumors.
  • The subject has a history of neurosurgery within the last 30 days.
  • Administration of blood transfusion after head injury and prior to the study blood draw.
  • The subject is a female who is pregnant or lactating.
  • The Subject is otherwise determined by the Investigator to be an unsuitable candidate for participation. If this criterion applies, a reason must be provided

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University of California San Diego

San Diego, California, 92103, United States

Location

Wayne State University - Detroit Receiving Hospital

Detroit, Michigan, 48201, 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

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Ludwig-Maximilians-University

Munich, DE-80336, Germany

Location

Klinikum rechts der Isar of the Technical University of Munich

Munich, DE-81675, Germany

Location

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

May 7, 2015

First Posted

May 12, 2015

Study Start

June 1, 2015

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

August 8, 2017

Record last verified: 2017-08

Locations

US(5)DE(2)