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

Phase 4

Completed

Conditions: traumatisch hersenletsel
Brain damage
Traumatic Brain Injury

Registration Number: NL-OMON45901

Lead Sponsor: Banyan Biomarkers, Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 500

Inclusion Criteria

1. The Subject is at least 18 years of age at screening.
2. 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.
3. The Subject has a Glasgow Coma Scale score of 9-15 at the time of Informed Consent.
4. The venous blood sample is collected no later than 12 hours from the time of head injury.
5. The Subject or their Next of Kin is willing to undergo the Informed Consent process prior to enrollment into this study

Exclusion Criteria

1. Participating in any other interventional, therapeutic clinical study (an observational study would be acceptable).
2. Time of suspected head injury cannot be determined.
3. 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)).
4. Blood transfusion after head injury, and prior to study blood draw
5. Blood donation within 1 week of study enrollment.
6. The subject is a female who is pregnant or lactating.
7. The Subject is otherwise determined by the Principal Investigator to be an unsuitable candidate for participation

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The purpose of this study is to collect fresh whole blood from subjects who<br /><br>have had a suspected mild to moderate head injury (Glasgow Coma Scale score<br /><br>9-15), for testing and evaluation of an investigational diagnostic assay<br /><br>platform (Philips Minicare POC). The fresh whole blood samples collected in<br /><br>this study will be used to help verify that both UCH-L1 and GFAP can be<br /><br>detected with the Philips Minicare POC diagnostic test platform. The<br /><br>procedures for testing specimens on the Philips Minicare POC, including the<br /><br>criteria for demonstrating proficiency of assay performance, will be described<br /><br>in a separate protocol maintained by the Sponsor. If successful, a clinical<br /><br>study will be designed and conducted to validate that the Philips Minicare POC<br /><br>diagnostic test meets the proposed Intended Use.</p><br>

Secondary Outcome Measures