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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 : September 3, 2020
Sponsor:
Collaborator:
Turku University Hospital
Information provided by (Responsible Party):
Medicortex Finland Oy

Study Description
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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

Detailed Description:

Staff of the Neurosurgical ward is asked to report to the study coordinator all patients who are hospitalized due to a suspected brain injury. After an informed consent is received, the patient has been enrolled in the study and sample collection can be started. Plasma samples are taken by the TYKSlab personnel, and the other samples by the nurses in the Neurosurgical ward. The sampling will be organized so that all the samples from a patient are preferably collected at one event. Samples will stored in the TYKSlab at the temperature of -70 °C. Collection of a sufficient number of samples (patients) will take a few months, and subsequent analysis by the Sponsor a few months. All the activities will be done during the years 2016 to 2017.

When the samples of 24 subjects have been collected, they will be transferred to the Sponsor who will ship them further to the sub-contractors. The results received from the research laboratories will be evaluated by the scientist team at Medicortex Finland Oy. The results will be published in a scientific journal, when considered to be of high enough quality and impact.

Study Design
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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

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Groups and Cohorts
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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.
 Other: Withdrawal of blood
Withdrawal of blood
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.
 Other: Withdrawal of blood
Withdrawal of blood


Outcome Measures
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Primary Outcome Measures :
  1. Presence of lectin-complexes in patients with TBI [ Time Frame: Two years ]
    There is a difference in the intensity of immuno-fluorescence readings between TBI patients and healthy controls. Different lectin bound complexes will be studied in body fluid samples collected from the patients (the trial is not following the patients nor is it intended to evaluate clinical outcome).

  2. Characterization of molecule structure of lectin-complexes [ Time Frame: Two years ]
    Molecular characterization of lectin-complexes by HPLC (high performance liquid chromatography) and MS (mass spectrometry) analysis. Samples retrieved from the patients are being analyzed comparing head injured to healthy controls. No follow-up of the patients and no clinical evaluation.


Biospecimen Retention:   Samples Without DNA
Blood, urine, and saliva.

Eligibility Criteria
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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.
Contacts and Locations
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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
More Information
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Responsible Party: Medicortex Finland Oy
ClinicalTrials.gov Identifier: NCT02836951    
Other Study ID Numbers: T129/2016
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: September 3, 2020
Last Verified: September 2020
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System