Fresh Intravenous Blood Samples for TBI Diagnostic Assay... | NCT03060109

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

NCT03060109

Sponsor

Banyan Biomarkers, Inc

Status

Terminated

Last Update Posted

Oct 2, 2017Actual

Enrollment

317Actual

Phase

Not provided

Conditions

Traumatic Brain Injury

Interventions

Blood draw within 12 hours of injury

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Diagnostic platform no longer under development; study termination not related to any safety issues

Expanded Access Info

Start Date

Jun 21, 2016Actual

Primary Completion Date

Sep 10, 2017Actual

Completion Date

Sep 10, 2017Actual

First Submitted Date

Feb 17, 2017

First Submission Date that Met QC Criteria

Feb 17, 2017

First Posted Date

Feb 23, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 28, 2017

Last Update Posted Date

Oct 2, 2017Actual

Name	Class
U.S. Army Medical Research and Development Command	FED

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

317Actual

Label	Type	Description	Intervention Names
Suspected traumatic brain injury			Other: Blood draw within 12 hours of injury

Name	Type	Description	Arm Group Labels	Other Names
Blood draw within 12 hours of injury	Other		Suspected traumatic brain injury

Measure	Description	Time Frame
Measurement of biomarkers	Measurement of UCH-L1 and GFAP using Philips Minicare	12 hours

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Maastricht University Medical Center		Maastricht		6202 AZ	Netherlands
Radboud University Medical Center

ID	Term
D000070642	Brain Injuries, Traumatic
D006259	Craniocerebral Trauma

ID	Term
D001930	Brain Injuries
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases