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

NCT03060109 | Terminated

• 1 other identifier: ATO-13
• Study Type: observational
• Target: 317
• Locations: 1 country
• Sites: 4

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.

Conditions

Traumatic Brain Injury

Keywords

Traumatic brain injury; Head injury

Outcome Measures

Primary Outcomes (1)

• Measurement of biomarkers

  Measurement of UCH-L1 and GFAP using Philips Minicare

  12 hours

Study Arms (1)

Suspected traumatic brain injury

Other: Blood draw within 12 hours of injury

Interventions

Blood draw within 12 hours of injury OTHER

Suspected traumatic brain injury

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Suspected head injury subjects over the age of 18 who present to the HCF or ED within 12 hours from the time of head injury. Subjects who will be permitted into the study include those who will meet all the inclusion criteria and will have none of the exclusion criteria.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (4)

Maastricht University Medical Center

Maastricht, 6202 AZ, Netherlands

Location

Radboud University Medical Center

Nijmegen, 6525 GA, Netherlands

Location

Erasmus Medical Center

Rotterdam, 3000 CA, Netherlands

Location

Haaglanden MC Westeinde

The Hague, 2512 VA, Netherlands

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Craniocerebral Trauma

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2017
• First Posted: February 23, 2017
• Study Start: June 21, 2016
• Primary Completion: September 10, 2017
• Study Completion: September 10, 2017
• Last Updated: October 2, 2017

Record last verified: 2017-09

Locations

NL (4)