Role of Concentration of Biomarkers S100B and NSE in Serum in Mild and Moderate Head Trauma

Biomarkers Clinical Trial

Official title:

Role of Concentration of Biomarkers S100B and NSE in Serum in Mild and Moderate Head Trauma Injury in Acute Phase in Relation to Head CT and Post Concusion Syndrome.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02988102
• Other study ID #: FKelmendi
• Status: Recruiting
• Phase: N/A
• First received: December 6, 2016
• Last updated: December 8, 2016
• Start date: December 2016
• Est. completion date: August 2017

Study information

• Verified date: December 2016
• Source: University Clinical Centre of Kosova
• Contact: Fatos Kelmendi
• Phone: +377 44 128 255
• Email: dr.kelmendifatos[@]gmail.com
• Is FDA regulated: No
• Health authority: Kosovo: Medical Faculty Ethical Board
• Study type: Observational

Clinical Trial Summary

In pediatric age groups communication difficulties very sometimes may present further obstacles in obtaining a detailed injury history and early identification of TBI symptoms.

Most emergency management protocols are focused exclusively on the identification of the relatively small number of patients who may require operative intervention, as early surgery is believed to improve outcome.

Description:

However early rehabilitation can also be effective for the much larger number of patients who do not require surgery[1] In addition, Hall and others recently reported that low doses of ionizing radiation to the brain in infancy may influence cognitive abilities in adulthood. [2] Accordingly, increased serum concentrations of, for example S100B ( a calcium-binding protein present in high concentrations in glial cells) and neurone-specific enolase ( NSE: a cytoplasmatic enzyme occuring predominantly in neurones ) have been demonstrated to reflect the presence and severity of brain tissue damage in acute head injuries. [3] In both pediatric age and adults.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: August 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Year to 65 Years

Eligibility

Inclusion Criteria:

• Only head trauma without any other body injury

Exclusion Criteria:

• Blood thinner, hydrocephalus , previous brain infarcts, encephalopathy, birth trauma.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Biomarkers
• Craniocerebral Trauma

Intervention

Other:
• Following S100B and NSE in head trauma
Following S100B and NSE in head trauma in correlation with Head CT and post concussion syndrome and Lisat11

Locations

Country	Name	City	State
Albania	Fatos Kelmendi	Tirana	Kosovo Prishtina

Sponsors (1)

Lead Sponsor	Collaborator
University Clinical Centre of Kosova

Country where clinical trial is conducted

Albania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Role of concentration of biomarkers S100B and NSE in serum in mild and moderate head trauma injury in acute phase in relation to head CT and post concusion syndrome.		2 years	Yes