Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 3 for:    medicortex
Previous Study | Return to List | Next Study

Rapid Biochemical Diagnostics of Traumatic Brain Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03306563
Recruitment Status : Active, not recruiting
First Posted : October 11, 2017
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
Medicortex Finland Oy

Tracking Information
First Submitted Date  ICMJE September 29, 2017
First Posted Date  ICMJE October 11, 2017
Last Update Posted Date March 3, 2021
Actual Study Start Date  ICMJE December 28, 2017
Actual Primary Completion Date January 23, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 11, 2017)
Biomarker level [ Time Frame: One year (1 year) ]
Analytical measurement of the biomarker level. (biodegradation glycans detected by HPLC-MS).
Original Primary Outcome Measures  ICMJE
 (submitted: October 5, 2017)
Biomarker level [ Time Frame: One year (1 year) ]
Analytical measurement of the biomarker level.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rapid Biochemical Diagnostics of Traumatic Brain Injury
Official Title  ICMJE Rapid Biochemical Diagnostics of Traumatic Brain Injury
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Traumatic Brain Injury
  • Concussion, Mild
  • Bone Fracture
Intervention  ICMJE Diagnostic Test: Sample collection
Samples of blood, urine and saliva will be collected at up to five successive time points.
Study Arms  ICMJE
  • 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.
    Intervention: Diagnostic Test: Sample collection
  • Active Comparator: Orthopedic patients
    The group will consist of patients with orthopedic injury, but without a head injury and suspected TBI. Sample collection (once).
    Intervention: Diagnostic Test: Sample collection
  • Sham Comparator: Controls
    The group will consist of healthy controls who do not have a recent trauma history. Sample collection (once).
    Intervention: Diagnostic Test: Sample collection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 5, 2019)
68
Original Estimated Enrollment  ICMJE
 (submitted: October 5, 2017)
160
Estimated Study Completion Date  ICMJE December 31, 2021
Actual Primary Completion Date January 23, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03306563
Other Study ID Numbers  ICMJE T213/2017
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Data will not be shared with other researchers.
Responsible Party Medicortex Finland Oy
Study Sponsor  ICMJE Medicortex Finland Oy
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mårten Kvist, MD/PhD Medicortex Finland Oy
PRS Account Medicortex Finland Oy
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP