Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02988102
Recruitment Status : Unknown
Verified December 2016 by Dr. Fatos Kelmendi, University Clinical Centre of Kosova.
Recruitment status was:  Recruiting
First Posted : December 9, 2016
Last Update Posted : December 9, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. Fatos Kelmendi, University Clinical Centre of Kosova

Tracking Information
First Submitted Date December 6, 2016
First Posted Date December 9, 2016
Last Update Posted Date December 9, 2016
Study Start Date December 2016
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 8, 2016)
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. [ Time Frame: 2 years ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Role of Concentration of Biomarkers S100B and NSE in Serum in Mild and Moderate Head Trauma
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.
Brief 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.

Detailed 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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Biomarkers S100B and NSE in blood sample ( Venous blood)
Sampling Method Probability Sample
Study Population 2 groups pediatric and adult.
Condition Biomarkers
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
Other Name: S100B NSE
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: December 8, 2016)
70
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 2017
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Only head trauma without any other body injury

Exclusion Criteria:

  • Blood thinner, hydrocephalus , previous brain infarcts, encephalopathy, birth trauma.
Sex/Gender
Sexes Eligible for Study: All
Ages 1 Year to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Albania
Removed Location Countries  
 
Administrative Information
NCT Number NCT02988102
Other Study ID Numbers FKelmendi
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Dr. Fatos Kelmendi, University Clinical Centre of Kosova
Study Sponsor University Clinical Centre of Kosova
Collaborators Not Provided
Investigators Not Provided
PRS Account University Clinical Centre of Kosova
Verification Date December 2016