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Rapid Biochemical Diagnostics of Traumatic Brain Injury

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ClinicalTrials.gov Identifier: NCT03306563
Recruitment Status : Recruiting
First Posted : October 11, 2017
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Medicortex Finland Oy

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Concussion, Mild Bone Fracture Diagnostic Test: Sample collection Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Total of 160 patients Phase 2a, 60 patients divided in three groups with TBI, orthopedic injury, and healthy volunteers (controls).

Phase 2b: 100 patients with concussion and mild traumatic brain injury.

Masking: Single (Outcomes Assessor)
Masking Description: Analytical evaluation and testing laboratories will get the samples blinded (coded).
Primary Purpose: Diagnostic
Official Title: Rapid Biochemical Diagnostics of Traumatic Brain Injury
Actual Study Start Date : December 7, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Biomarker level [ Time Frame: One year (1 year) ]
    Analytical measurement of the biomarker level. (biodegradation glycans detected by HPLC-MS).



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT03306563


Contacts
Contact: Jussi Posti, MD/PhD +358 2 313 0282 jussi.posti@tyks.fi
Contact: Mårten Kvist, MD/PhD +358 44 55 29 334 marten.kvist@pp.inet.fi

Locations
Finland
Satakunta Central Hospital Recruiting
Pori, Finland, 28500
Contact: Juha Kukkonen, MD, PhD         
Turku University Hospital (Tyks) Recruiting
Turku, Finland
Contact: Jussi Posti, MD, PhD    +358 2 313 0282    jussi.posti@tyks.fi   
Vaasa Central Hospital Recruiting
Vaasa, Finland, 65130
Contact: Maria Turkki, MD         
Sponsors and Collaborators
Medicortex Finland Oy
Investigators
Study Director: Mårten Kvist, MD/PhD Medicortex Finland Oy

Responsible Party: Medicortex Finland Oy
ClinicalTrials.gov Identifier: NCT03306563     History of Changes
Other Study ID Numbers: T213/2017
First Posted: October 11, 2017    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will not be shared with other researchers.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Medicortex Finland Oy:
TBI
Mild traumatic brain injury
Concussion
Diagnostics
Rapid test
Traumatic Brain Injury
mTBI

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Fractures, Bone
Brain Concussion
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds, Nonpenetrating