Rapid Biochemical Diagnostics of Traumatic Brain Injury

The objective of the study is to confirm the clinical relevance of the novel biomarker for traumatic brain injury (TBI) detection. Samples of blood, urine and saliva will be collected from a) patients with suspected TBI (isolated), b) patients with orthopedic injury, and c) healthy controls. The sponsor will do biochemical investigations for the samples to evaluate the presence, level and structure of the targeted biomarker.

Study Overview

• Status: Completed
• Conditions: Traumatic Brain Injury; Concussion, Mild; Bone Fracture
• Intervention / Treatment: Diagnostic test: Sample collection

Detailed Description

The study will analyze and compare the levels of certain biomolecules and cellular degradation products which are released upon a brain injury and which become detectable in the body fluids. Patients with a traumatic brain injury are supposed to express these biomarkers in their body fluids while orthopedic trauma patients and healthy controls are supposed to be undetectable with respect to these biomolecules. The study is a case-control study where the study subjects with a property (injured) are compared to subjects without the property (healthy). The brain injury patient group will consist of subjects who entered the Emergency Department of the hospital with a suspected TBI. The orthopedic patient group will consists of patients who were admitted with a bone fracture in the limbs, but without a suspected TBI. The control group will consist of healthy subjects who will be recruited to the study by the activities of the study personnel.

The entire study is split into two successive parts. In the first Part I, 18 - 24 subjects will be recruited in each group. In the second part, the number of the patients with suspected TBI will be added to up to 100 in order to receive an adequate number of samples and to gain sufficient statistical significance between the brain injury severities and in successive sampling time points.

The collected samples and relevant clinical data of each subject will be supplied to the sponsor who will perform to the samples 1) Biochemical analysis for the presence and level of the biomarker, and 2) Biomarker profiling and structure analysis by LC/MS.

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Pori, Finland, 28500
    • Satakunta Central Hospital
  • Turku, Finland
    • Turku University Hospital (TYKS)
  • Vaasa, Finland, 65130
    • Vaasa Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Signed written informed consent form (Finnish or Swedish)
• Age 18 - 75 years (Male or Female)
• For patients with a suspected TBI: Presenting to the ED within 4 hours after the injury, and no orthopedic trauma (fractures of long bones) present.
• For patients with a suspected TBI: Deemed to have a computed tomography (CT) scan as a part of their intended medical diagnosis and treatment.
• For patients with orthopedic injuries: Presentation with a bone fracture, but without any suspicion of any TBI.

Exclusion Criteria:

• Unknown time of trauma (uncertainty more than 1 hour).
• More than 4 hours from the injury.
• Known or suspected pre-existing neurological condition that can cause the observed symptoms
• For women of child-bearing age: known to be or suspected to be pregnant.
• History of seizures within the last three months.
• History of infection with HIV or hepatitis B, or diagnosed to be positive in the concomitant screening.
• Patients where the presence of TBI cannot be assessed reliably because of alcohol or drugs, especially current use of anti-psychotic or anxiolytic medication.
• History of stroke within three months.
• The subject has a chronic neurodegenerative, metabolic (e.g. diabetes), or an autoimmune disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with suspected TBI; The group will consist of patients who have arrived in the hospital with head injury and suspected isolated TBI. Sample collection (up to five times) and assessment of neurological status.	Diagnostic test: Sample collection; Samples of blood, urine and saliva will be collected at up to five successive time points.
Active Comparator: Orthopedic patients; The group will consist of patients with orthopedic injury, but without a head injury and suspected TBI. Sample collection (once).	Diagnostic test: Sample collection; Samples of blood, urine and saliva will be collected at up to five successive time points.
Sham Comparator: Controls; The group will consist of healthy controls who do not have a recent trauma history. Sample collection (once).	Diagnostic test: Sample collection; Samples of blood, urine and saliva will be collected at up to five successive time points.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomarker level	Analytical measurement of the biomarker level. (biodegradation glycans detected by HPLC-MS).	One year (1 year)

Collaborators and Investigators

• Sponsor: Medicortex Finland Oy
• Investigators: Study Director: Mårten Kvist, MD/PhD, Medicortex Finland Oy

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2017
• Primary Completion (Actual): January 23, 2019
• Study Completion (Actual): June 7, 2021

Study Registration Dates

• First Submitted: September 29, 2017
• First Submitted That Met QC Criteria: October 5, 2017
• First Posted (Actual): October 11, 2017

Study Record Updates

• Last Update Posted (Actual): June 8, 2021
• Last Update Submitted That Met QC Criteria: June 7, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: mTBI; Concussion; TBI; Traumatic Brain Injury; Diagnostics; Mild traumatic brain injury; Rapid test
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Fractures, Bone; Brain Concussion
• Other Study ID Numbers: T213/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Data will not be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No