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

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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

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.


Condition or disease Intervention/treatment
Biomarkers Other: Following S100B and NSE in head trauma

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.

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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
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.
Study Start Date : December 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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


Primary Outcome Measures :
  1. 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 ]

Biospecimen Retention:   Samples Without DNA
Biomarkers S100B and NSE in blood sample ( Venous blood)


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
2 groups pediatric and adult.
Criteria

Inclusion Criteria:

  • Only head trauma without any other body injury

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02988102


Contacts
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Contact: Fatos Kelmendi +377 44 128 255 dr.kelmendifatos@gmail.com
Contact: Agon Mekaj, PhD +377 44 373545 dragonmekaj@gmail.com

Locations
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Albania
Fatos Kelmendi Recruiting
Tirana, Kosovo Prishtina, Albania, 10 000
Contact: Agon Mekaj, PhD    +37744373545    dragonmekaj@gmail.com   
Contact: Ridvan Alimehmeti, PhD    +355692102140    ridvanalimehmeti@hotmail.com   
Sponsors and Collaborators
University Clinical Centre of Kosova

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Responsible Party: Dr. Fatos Kelmendi, Dr. Fatos Kelmendi Neurosurgeon, University Clinical Centre of Kosova
ClinicalTrials.gov Identifier: NCT02988102     History of Changes
Other Study ID Numbers: FKelmendi
First Posted: December 9, 2016    Key Record Dates
Last Update Posted: December 9, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Dr. Fatos Kelmendi, University Clinical Centre of Kosova:
S100B, NSE
moderate brain trauma
mild brain trauma
Additional relevant MeSH terms:
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Craniocerebral Trauma
Wounds and Injuries
Trauma, Nervous System
Nervous System Diseases