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Rapid Diagnostics for Traumatic Brain Injury (TBI)

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ClinicalTrials.gov Identifier: NCT02836951
Recruitment Status : Completed
First Posted : July 19, 2016
Last Update Posted : February 3, 2017
Sponsor:
Collaborator:
Turku University Hospital
Information provided by (Responsible Party):
Medicortex Finland Oy

Brief Summary:
Novel biomarkers of traumatic brain injury (TBI) have been discovered in laboratory animal models. The objective of this study is to find whether similar markers are detectable in the body fluids of human subjects that have sustained a TBI.

Condition or disease Intervention/treatment
Traumatic Brain Injury Other: Withdrawal of blood and CSF

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Study Type : Observational
Actual Enrollment : 24 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Rapid Chemical Diagnostics of Brain Injuries
Actual Study Start Date : September 2016
Actual Primary Completion Date : January 31, 2017
Actual Study Completion Date : January 31, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patient
This group consists of patients that are hospitalized due to a head injury. Samples of blood, urine and plasma will taken from these subjects and the fluids will be analyzed for novel biomarkers using a biochemical assay. Cerebrospinal fluid (CSF) will be drawn in cases when sampling is justified for treatment, not for study purpose solely.
Other: Withdrawal of blood and CSF
Withdrawal of blood and CSF

Healthy controls
This group consists of healthy volunteers. Samples of blood, urine and plasma will taken from these subjects and the fluids will be analyzed for novel biomarkers using a biochemical assay. Cerebrospinal fluid (CSF) will be drawn only upon person's own consent.
Other: Withdrawal of blood and CSF
Withdrawal of blood and CSF




Primary Outcome Measures :
  1. Presence of biomarkers in humans with TBI. [ Time Frame: One year ]

Biospecimen Retention:   Samples Without DNA
Blood, urine, saliva and cerebrospinal fluid (CSF).


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Study population will include patients that are hospitalized due to a suspected traumatic brain injury. Identical number of healthy volunteers will serve as controls.
Criteria

Inclusion Criteria:

  • Patient is hospitalized because of a head trauma and suspected TBI.
  • Age 18 or above. The subject (including the control subjects) must be an independent adult who is not under guardianship.
  • The patient, or the next of kin in the case of an incompetent person, has signed the Informed consent. This concerns the control subjects, too.
  • The samples can be collected during regular office hours.
  • The patient needs lumbar puncture for treatment reasons. This is not a limiting criterion however. If it is difficult to find an adequate number of patients for lumbar puncture, CSF samples of some patients can be omitted after the study coordinator's consideration.

Exclusion Criteria:

  • The subject has been found positive for HIV or hepatitis-B in the involved laboratory studies.
  • The subject has a chronic mental disorder which is mentioned on the sickness insurance card.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02836951


Locations
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Finland
Turku University Hospital (Tyks)
Turku, Finland
Sponsors and Collaborators
Medicortex Finland Oy
Turku University Hospital
Investigators
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Principal Investigator: Jaakko Rinne, Professor University of Turku

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Responsible Party: Medicortex Finland Oy
ClinicalTrials.gov Identifier: NCT02836951     History of Changes
Other Study ID Numbers: T129/2016
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: February 3, 2017
Last Verified: July 2016

Additional relevant MeSH terms:
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Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System