Fresh Intravenous Blood Samples for TBI Diagnostic Assay Development With Philips Point of Care System (FIRST DOWN)

Fresh Intravenous Blood Samples for TBI Diagnostic Assay Development With Philips Point of Care System (FIRST DOWN)

The purpose of this study is to collect fresh whole blood within 12 hours from suspected mild head injury (Glasgow Coma Scale score 13-15) from subjects over the age of 18, to help verify that both UCH-L1 and GFAP can be detected with the Philips Minicare POC diagnostic test platform.

Study Overview

• Status: Terminated
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Other: Blood draw within 12 hours of injury

• Study Type: Observational
• Enrollment (Actual): 317

Contacts and Locations

Study Locations

• Netherlands
  • Maastricht, Netherlands, 6202 AZ
    • Maastricht University Medical Center
  • Nijmegen, Netherlands, 6525 GA
    • Radboud university medical center
  • Rotterdam, Netherlands, 3000 CA
    • Erasmus Medical Center
  • The Hague, Netherlands, 2512 VA
    • Haaglanden MC Westeinde

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Suspected head injury subjects over the age of 18 who present to the HCF or ED within 12 hours from the time 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.

Description

Inclusion Criteria:

• The Subject is at least 18 years of age at screening.
• The Subject has presented to a Health Care Facility or Emergency Department with a suspected traumatically induced head injury, as a result of insult to the head from an external force.
• The Subject has a Glasgow Coma Scale score of 13-15 at the time of Informed Consent.
• The venous blood sample is collected no later than 12 hours from the time of head injury.
• The Subject is competent and willing to undergo the Informed Consent process

Exclusion Criteria:

• Participating in any other interventional, therapeutic clinical study (an observational study would be acceptable).
• Time of suspected head injury cannot be determined.
• 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)).
• Blood transfusion after head injury, and prior to study blood draw
• Blood donation within 1 week of study enrollment.
• The subject is a female who is pregnant or lactating.
• The Subject is otherwise determined by the Principal Investigator to be an unsuitable candidate for participation

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Suspected traumatic brain injury	Other: Blood draw within 12 hours of injury

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of biomarkers	Measurement of UCH-L1 and GFAP using Philips Minicare	12 hours

Collaborators and Investigators

• Sponsor: Banyan Biomarkers, Inc
• Collaborators: U.S. Army Medical Research and Development Command

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2016
• Primary Completion (Actual): September 10, 2017
• Study Completion (Actual): September 10, 2017

Study Registration Dates

• First Submitted: February 17, 2017
• First Submitted That Met QC Criteria: February 17, 2017
• First Posted (Actual): February 23, 2017

Study Record Updates

• Last Update Posted (Actual): October 2, 2017
• Last Update Submitted That Met QC Criteria: September 28, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Traumatic brain injury; Head injury
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: ATO-13

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No