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

NCT ID: NCT03060109

Last Updated: 2017-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

317 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-21

Study Completion Date

2017-09-10

Brief Summary

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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.

Detailed Description

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Conditions

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Traumatic Brain Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Suspected traumatic brain injury

Blood draw within 12 hours of injury

Intervention Type OTHER

Interventions

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Blood draw within 12 hours of injury

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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U.S. Army Medical Research and Development Command

FED

Sponsor Role collaborator

Banyan Biomarkers, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Maastricht University Medical Center

Maastricht, , Netherlands

Site Status

Radboud University Medical Center

Nijmegen, , Netherlands

Site Status

Erasmus Medical Center

Rotterdam, , Netherlands

Site Status

Haaglanden MC Westeinde

The Hague, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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ATO-13

Identifier Type: -

Identifier Source: org_study_id