Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04288167
Other study ID # T257/2019
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 14, 2020
Est. completion date April 14, 2021

Study information

Verified date April 2021
Source Medicortex Finland Oy
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 58
Est. completion date April 14, 2021
Est. primary completion date April 14, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 17 Years
Eligibility Inclusion Criteria: - The subject is suspected of having an isolated mild TBI (Glasgow Coma Score 13 - 15) - No more that 6 hours elapsed from the incident of injury at the first sampling - The patient is conscious - Informed consent received from the legal guardian, and the subject him-/herself when literate and capable of understanding study measures Exclusion Criteria: - More than 6 hours elapsed from the injury, or unknown time of trauma - Multi-trauma patient - History of head injury, seizures or stroke within three preceding months - Chronic neurodegenerative, metabolic or autoimmune disease - Known existing neurological condition

Study Design


Intervention

Diagnostic Test:
Sample collection
Samples of urine and saliva will be collected from participants using customary sample collection means.

Locations

Country Name City State
Finland Satakunta Central Hospital Pori

Sponsors (2)

Lead Sponsor Collaborator
Medicortex Finland Oy Satasairaala

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Biomarker levels Quantitative measurement of the novel glycan-based biomarker using a lectin-binding assay 12 months
Primary Biomarker profiles Characterization of different glycan structures present in the sample by mass spectrometry analysis 12 months
See also
  Status Clinical Trial Phase
Recruiting NCT04111549 - GOALS Cognitive Training Delivered to Aging Veterans in Person or Via Telehealth N/A
Recruiting NCT05097261 - Ketamine in Acute Brain Injury Patients. Phase 4
Completed NCT03504709 - REsting and Stimulus-based Paradigms to Detect Organized NetworkS and Predict Emergence of Consciousness
Recruiting NCT03899532 - Remote Ischemic Conditioning in Traumatic Brain Injury N/A
Completed NCT05057377 - Estimating Highest Capacity Performance During Evaluation of Walking for Individuals With Traumatic Brain Injury
Withdrawn NCT02776488 - Exogenous Sodium Lactate Infusion in Traumatic Brain Injury (ELI-TBI) Phase 2
Completed NCT02426749 - Treatment and Recovery Monitoring of Post TBI Symptoms N/A
Completed NCT01339702 - The EPIC Project: Impact of Implementing the EMS Traumatic Brain Injury Treatment Guidelines
Recruiting NCT05977270 - The Effects of Lifebloom One on Physical Activity After Acquired Brain Injury N/A
Recruiting NCT04666766 - Detecting Traumatic Intracranial Hemorrhage With Microwaves and Biomarkers N/A
Active, not recruiting NCT04559724 - Gait Training Through a Novel Over-ground Wearable Robotic System in People With Pyramidal Hemisyndromes N/A
Not yet recruiting NCT04515420 - The Influence of Noradrenaline on Coagulation and Fibrinolysis in Severe Isolated Brain Injury
Not yet recruiting NCT05569993 - Glutamine and Traumatic Brain Injury Early Phase 1
Recruiting NCT04331392 - Online Memory Intervention for Individuals With Traumatic Brain Injury N/A
Completed NCT03727737 - Efficacy of Repetitive Transcranial Magnetic Stimulation for Improvement of Memory in Older Adults With TBI N/A
Completed NCT03153397 - Effect of Prebiotic Fiber- Enriched (scFOS) Enteral Feeding on the Microbiome in Neurological Injury Trauma Patients (PreFEED Microbiome Trial) N/A
Completed NCT01336413 - Neuroactive Steroids and Traumatic Brain Injury (TBI) in OEF/OIF Veterans Phase 2
Completed NCT02004080 - CREACTIVE - Collaborative REsearch on ACute Traumatic Brain Injury in intensiVe Care Medicine in Europe
Completed NCT04957563 - Clinical Utility of Olfactory Rehabilitation: Treatment for Pacients With Neurosensorial Anosmia N/A
Completed NCT05179330 - Visual Feedback in Lower Limb Rehabilitation N/A