NCT02836951

Rapid Diagnostics for Traumatic Brain Injury (TBI)

Rapid Chemical Diagnostics of Brain Injuries

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 24 (actual)
• Sponsor: Medicortex Finland Oy · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Novel biomarkers of traumatic brain injury (TBI) have been discovered in laboratory animal models. The objective of this study is to find whether similar markers are detectable in the body fluids of human subjects that have sustained a TBI.

Detailed description

Staff of the Neurosurgical ward is asked to report to the study coordinator all patients who are hospitalized due to a suspected brain injury. After an informed consent is received, the patient has been enrolled in the study and sample collection can be started. Plasma samples are taken by the TYKSlab personnel, and the other samples by the nurses in the Neurosurgical ward. The sampling will be organized so that all the samples from a patient are preferably collected at one event. Samples will stored in the TYKSlab at the temperature of -70 °C. Collection of a sufficient number of samples (patients) will take a few months, and subsequent analysis by the Sponsor a few months. All the activities will be done during the years 2016 to 2017. When the samples of 24 subjects have been collected, they will be transferred to the Sponsor who will ship them further to the sub-contractors. The results received from the research laboratories will be evaluated by the scientist team at Medicortex Finland Oy. The results will be published in a scientific journal, when considered to be of high enough quality and impact.

Conditions

• Traumatic Brain Injury

Interventions

Type	Name	Description
OTHER	Withdrawal of blood	Withdrawal of blood

Timeline

• Start date: 2016-09-01
• Primary completion: 2017-01-31
• Completion: 2017-01-31
• First posted: 2016-07-19
• Last updated: 2020-09-03

Locations

1 site across 1 country: Finland