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

• Sponsor: Banyan Biomarkers, Inc (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03060109
• Collaborator: U.S. Army Medical Research and Development Command (U.S. Fed)
• Enrollment: 317
• Locations: 4
• Actual Duration (Months): 14.7
• Patients Per Site: 79.3
• Patients Per Site Per Month: 5.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Traumatic Brain Injury	Other: Blood draw within 12 hours of injury

Study Design

• Study Type: Observational
• Actual Enrollment: 317 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Fresh Intravenous Blood Samples for TBI Diagnostic Assay Development With Philips Point of Care System (FIRST DOWN)
• Actual Study Start Date: Jun 21, 2016
• Actual Primary Completion Date: Sep 10, 2017
• Actual Study Completion Date: Sep 10, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Measurement of biomarkers [12 hours]

   Measurement of UCH-L1 and GFAP using Philips Minicare

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maastricht University Medical Center	Maastricht		Netherlands	6202 AZ
2	Radboud University Medical Center	Nijmegen		Netherlands	6525 GA
3	Erasmus Medical Center	Rotterdam		Netherlands	3000 CA
4	Haaglanden MC Westeinde	The Hague		Netherlands	2512 VA

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Banyan Biomarkers, Inc
• ClinicalTrials.gov Identifier: NCT03060109
• Other Study ID Numbers: ATO-13
• First Posted: Feb 23, 2017
• Last Update Posted: Oct 2, 2017
• Last Verified: Sep 1, 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Banyan Biomarkers, Inc: Traumatic brain injury; Head injury
• Additional relevant MeSH terms: Brain Injuries; Brain Injuries, Traumatic

Study Results

No Results Posted as of Oct 2, 2017