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| Name | Class |
|---|---|
| Satasairaala | OTHER |
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The study will enroll children and adolescents (0 - 17 years) suspected of having concussion or mild traumatic brain injury (TBI). Samples of urine and saliva will be collected from the patients as well as from corresponding age- and gender-adjusted healthy controls.
The collected samples will be alienated to the Sponsor who will perform biochemical studies to identify and measure from the samples relative level of the brain injury-specific biomarkers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with suspected brain injury | Experimental | This arm will consist of up to 30 pediatric patients who entered the Emergency Room and who are suspected of having mild traumatic brain injury. Two sample sets will be collected within the first 10 hours from the injury. |
|
| Healthy controls | Active Comparator | This arm will consist of up to 30 healthy control subjects, the samples of whom will be compared to the samples of brain injury patients (Arm 1). One sample set will be collected from healthy children without any known brain injury. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sample collection | Diagnostic Test | Samples of urine and saliva will be collected from participants using customary sample collection means. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Biomarker levels | Quantitative measurement of the novel glycan-based biomarker using a lectin-binding assay | 12 months |
| Biomarker profiles | Characterization of different glycan structures present in the sample by mass spectrometry analysis | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sari Malmi, MD | Satasairaala | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Satakunta Central Hospital | Pori | 28500 | Finland |
Individual participant data shall not be shared to outside of the study.
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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The laboratories will analyze the samples blinded, without knowing whether the sample was from an injured patient or a healthy control.
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |