Rapid Diagnostics for Traumatic Brain Injury (TBI)

Rapid Chemical Diagnostics of Brain Injuries

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.

Study Overview

• Status: Completed
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• Finland
  • Turku, Finland
    • Turku University Hospital (TYKS)

Participation Criteria

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

Study population will include patients that are hospitalized due to a suspected traumatic brain injury. Identical number of healthy volunteers will serve as controls.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of lectin-complexes in patients with TBI	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).	Two years
Characterization of molecule structure of lectin-complexes	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.	Two years

Collaborators and Investigators

• Sponsor: Medicortex Finland Oy
• Collaborators: Turku University Hospital
• Investigators: Principal Investigator: Jaakko Rinne, Professor, University of Turku

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): January 31, 2017
• Study Completion (Actual): January 31, 2017

Study Registration Dates

• First Submitted: July 15, 2016
• First Submitted That Met QC Criteria: July 15, 2016
• First Posted (Estimate): July 19, 2016

Study Record Updates

• Last Update Posted (Actual): September 3, 2020
• Last Update Submitted That Met QC Criteria: September 1, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: T129/2016