Rapid Biochemical Diagnostics of Traumatic Brain Injury

NCT03306563 | Completed

• 1 other identifier: T213/2017
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 3

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.

Conditions

Traumatic Brain Injury; Concussion, Mild; Bone Fracture

Keywords

TBI; Mild traumatic brain injury; Concussion; Diagnostics; Rapid test; Traumatic Brain Injury; mTBI

Outcome Measures

Primary Outcomes (1)

• Biomarker level

  Analytical measurement of the biomarker level. (biodegradation glycans detected by HPLC-MS).

  One year (1 year)

Study Arms (3)

Patients with suspected TBI

EXPERIMENTAL

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

Orthopedic patients

ACTIVE COMPARATOR

The group will consist of patients with orthopedic injury, but without a head injury and suspected TBI. Sample collection (once).

Diagnostic Test: Sample collection

Controls

SHAM COMPARATOR

The group will consist of healthy controls who do not have a recent trauma history. Sample collection (once).

Diagnostic Test: Sample collection

Interventions

Sample collection DIAGNOSTIC_TEST

Samples of blood, urine and saliva will be collected at up to five successive time points.

Controls; Orthopedic patients; Patients with suspected TBI

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medicortex Finland Oy: lead

Study Sites (3)

Satakunta Central Hospital

Pori, 28500, Finland

Location

Turku University Hospital (Tyks)

Turku, Finland

Location

Vaasa Central Hospital

Vaasa, 65130, Finland

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Concussion; Fractures, Bone

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Head Injuries, Closed; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Mårten Kvist, MD/PhD

  Medicortex Finland Oy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Analytical evaluation and testing laboratories will get the samples blinded (coded).
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 29, 2017
• First Posted: October 11, 2017
• Study Start: December 28, 2017
• Primary Completion: January 23, 2019
• Study Completion: June 7, 2021
• Last Updated: June 8, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

FI (3)