Fresh Intravenous Blood Samples for TBI Diagnostic Assay Development With Philips Point of Care System

Terminated

• Conditions: Traumatic Brain Injury
• Interventions: Other: Blood draw within 12 hours of injury

• Registration Number: NCT03060109
• Lead Sponsor: Banyan Biomarkers, Inc

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-21
• Study First Submitted: 2017-02-17
• Study First Submitted QC: 2017-02-17
• Study First Posted: 2017-02-23
• Status Verified: 2017-09
• Primary Completion: 2017-09-10
• Study Completion: 2017-09-10
• Last Update Submitted: 2017-09-28
• Last Update Posted: 2017-10-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 317

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Suspected traumatic brain injury	Blood draw within 12 hours of injury	-

Primary Outcome Measures

Name	Time	Method
Measurement of biomarkers	12 hours	Measurement of UCH-L1 and GFAP using Philips Minicare

Trial Locations

Locations (4)

Radboud University Medical Center; 🇳🇱 Nijmegen, Netherlands

Maastricht University Medical Center; 🇳🇱 Maastricht, Netherlands

Erasmus Medical Center; 🇳🇱 Rotterdam, Netherlands

Haaglanden MC Westeinde; 🇳🇱 The Hague, Netherlands