MIND (Management of Traumatic Brain Injury Diagnosis) (MIND)

February 8, 2017 updated by: Abbott Diagnostics Division

Study to Procure Human Specimens for Use in the Diagnosis and Management of Traumatic Brain Injury and Other Related Conditions

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

239

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Munich, Germany, 81675
        • Klinikum rechts der Isar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Brain Injury
Control
Healthy, or Head Trauma, or Orthopedic Trauma, or Poly-Trauma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of specific biomarker(s) for brain injury
Time Frame: 48 hours
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Diagnostics Division

Investigators

  • Principal Investigator: Peter Biberthaler, MD/PHD, Klinikum reichs der Isar

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

September 23, 2014

First Submitted That Met QC Criteria

October 8, 2014

First Posted (Estimate)

October 13, 2014

Study Record Updates

Last Update Posted (Actual)

February 10, 2017

Last Update Submitted That Met QC Criteria

February 8, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9GP-02-10DELK14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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