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

Traumatic Brain Injury Clinical Trial

— FIRST DOWN  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03060109
• Other study ID #: ATO-13
• Status: Terminated
• Phase: N/A
• First received: February 17, 2017
• Last updated: September 28, 2017
• Start date: June 21, 2016
• Est. completion date: September 10, 2017

Study information

• Verified date: September 2017
• Source: Banyan Biomarkers, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 317
• Est. completion date: September 10, 2017
• Est. primary completion date: September 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Traumatic Brain Injury

Intervention

Other:
• Blood draw within 12 hours of injury

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht
Netherlands	Radboud University Medical Center	Nijmegen
Netherlands	Erasmus Medical Center	Rotterdam
Netherlands	Haaglanden MC Westeinde	The Hague

Sponsors (2)

Lead Sponsor	Collaborator
Banyan Biomarkers, Inc	U.S. Army Medical Research and Materiel Command

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of biomarkers	Measurement of UCH-L1 and GFAP using Philips Minicare	12 hours