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

Banyan International

Status: Terminated

Conditions: Traumatic Brain Injury

Treatments: Other: Blood draw within 12 hours of injury

Study type: Observational

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT03060109

ATO-13

Details and patient eligibility

About

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.

Enrollment: 317 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

317 participants in 1 patient group

Suspected traumatic brain injury

Treatment:

Other: Blood draw within 12 hours of injury