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NCT Number: NCT02836951

Rapid Diagnostics for Traumatic Brain Injury (TBI)

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.

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Turku University Hospital (Tyks)

Turku, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Withdrawal of blood

Other

Withdrawal of blood

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Medicortex Finland Oy

Industry

Collaborators

  • Turku University Hospital

Registry information

Official study title

Rapid Chemical Diagnostics of Brain Injuries

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 19, 2016
Registry last updated
Sep 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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