Rapid Biochemical Diagnostics of Traumatic Brain Injury
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ClinicalTrials.gov Identifier: NCT03306563 |
Recruitment Status :
Active, not recruiting
First Posted : October 11, 2017
Last Update Posted : March 3, 2021
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Tracking Information | |||||
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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 |
Biomarker level [ Time Frame: One year (1 year) ] Analytical measurement of the biomarker level. (biodegradation glycans detected by HPLC-MS).
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Original Primary Outcome Measures ICMJE |
Biomarker level [ Time Frame: One year (1 year) ] Analytical measurement of the biomarker level.
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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. |
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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 Description: Analytical evaluation and testing laboratories will get the samples blinded (coded). Primary Purpose: Diagnostic
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Condition ICMJE |
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Intervention ICMJE | Diagnostic Test: Sample collection
Samples of blood, urine and saliva will be collected at up to five successive time points.
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Actual Enrollment ICMJE |
68 | ||||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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IPD Sharing Statement ICMJE |
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Responsible Party | Medicortex Finland Oy | ||||
Study Sponsor ICMJE | Medicortex Finland Oy | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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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 |