MIND (Management of Traumatic Brain Injury Diagnosis) | NCT02262286

Studies
MIND (Management of Traumatic Brain Injury Diagnosis)

NCT02262286

Sponsor

Abbott Diagnostics Division

Status

Completed

Last Update Posted

Feb 10, 2017Actual

Enrollment

239Actual

Phase

Not provided

Conditions

Brain Injury

Interventions

Not provided

Countries

Germany

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

Feb 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2014

Primary Completion Date

Sep 2016Actual

Completion Date

Sep 2016Actual

First Submitted Date

Sep 23, 2014

First Submission Date that Met QC Criteria

Oct 8, 2014

First Posted Date

Oct 13, 2014Estimated

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

Feb 8, 2017

Last Update Posted Date

Feb 10, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

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

Retention

Enrollment

239Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Brain Injury		Brain Injury
Control		Healthy, or Head Trauma, or Orthopedic Trauma, or Poly-Trauma

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measurement of specific biomarker(s) for brain injury	Measurement of specific biomarkers to detect brain injury (mild to severe). using 2 or more serial draws from subjects. The biomarkers tested will include established biomarkers s100B, GFAP (Glial Fibrillary Acidic Protein) and also proprietary novel protein and lipid biomarkers that are being studied in discovery research.	48 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Informed Consent Form Signed
18 years of age or older
For women of child-bearing age: Not known to be pregnant AND
Head Trauma within 6 hours of ED presentation with Glasgow Coma Scores from 3-8 (Severe Injury), 9-13 (Moderate Injury), or 14-15 (Mild Injury); OR
Head trauma within 6 hours of ED presentation with Glasgow Coma Score of 15; OR
Bone fracture or poly-traumas, both with no head trauma

Exclusion Criteria:

Known pre-existing neurological condition that causes observed symptoms
Recent history of head injury or seizures (within 1 year of current ED presentation)
Prisoner

Accepts Healthy Volunteers

Yes

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

Individuals presenting to the ED within 6 hours of experiencing a head trauma, or bone fractions only.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter Biberthaler, MD/PHD	Klinikum reichs der Isar	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinikum rechts der Isar		Munich		81675	Germany

Condition Browse Module

MeSH Terms

ID	Term
D001930	Brain Injuries

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D006259	Craniocerebral Trauma

Browse Leaves

Not provided

Browse Branches

Not provided