NCT02262286

Brief Summary

Procure blood specimens from individuals presenting to the emergency department with suspected brain injury.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
239

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2014

Completed
20 days until next milestone

First Posted

Study publicly available on registry

October 13, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

February 10, 2017

Status Verified

February 1, 2017

Enrollment Period

2 years

First QC Date

September 23, 2014

Last Update Submit

February 8, 2017

Conditions

Brain Injury

Keywords

Brain Injury

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Brain Injury

Brain Injury

Control

Healthy, or Head Trauma, or Orthopedic Trauma, or Poly-Trauma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Informed Consent Form Signed
  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum rechts der Isar

Munich, 81675, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and serum samples stored at -70C or colder

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Peter Biberthaler, MD/PHD

    Klinikum reichs der Isar

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2014

First Posted

October 13, 2014

Study Start

September 1, 2014

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

February 10, 2017

Record last verified: 2017-02

Locations

DE(1)