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

Banyan Biomarkers, Inc0 个研究点目标入组 500 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

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•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

•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

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