BiomarkersNCT02988102
Role of Concentration of Biomarkers S100B and NSE in Serum in Mild and Moderate Head Trauma
An observational study of Biomarkers, run by University Clinical Centre of Kosova at 1 site in Albania.
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… Read more about this study
- Who is it for?
- Ages 1 year to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Biomarkers
- What is being tested?
- Following S100B and NSE in head trauma
- How many people
- 70 participants
- Where
- 1 siteAlbania
- Study dates
- Dec 2016to Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 2 groups pediatric and adult.
Who may be able to join
- Only head trauma without any other body injury
Who cannot join
- Blood thinner, hydrocephalus , previous brain infarcts, encephalopathy, birth trauma.
Trial locations and contacts
1 site in 1 country.
Albania1 site, 1 recruiting
- Recruiting
Fatos Kelmendi
Tirana, Kosovo Prishtina, 10 000
Agon Mekaj, PhD, +37744373545, dragonmekaj@gmail.com
Ridvan Alimehmeti, PhD, +355692102140, ridvanalimehmeti@hotmail.com
About this study
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.
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.
Read the 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.
- Conditions
- Biomarkers
- Being tested
- Following S100B and NSE in head trauma
- Keywords
- S100B, NSE, moderate brain trauma, mild brain trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Following S100B and NSE in head traumaOther
Also called S100B NSE
Following S100B and NSE in head trauma in correlation with Head CT and post concussion syndrome and Lisat11
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2016 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BiomarkersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Clinical Centre of Kosova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Fatos Kelmendi, University Clinical Centre of Kosova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02988102
- Sponsor's protocol ID
- FKelmendi
- Status last verified
- Dec 2016
- First submitted
- 6 Dec 2016
- Last updated
- 9 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02988102
- Acronym / sponsor ID
- FKelmendi
- Conditions
- Biomarkers
- Keywords
- S100B, NSE, moderate brain trauma, mild brain trauma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University Clinical Centre of KosovaUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 9 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 2 groups pediatric and adult.
Key inclusion criteria (1 listed)
- Only head trauma without any other body injury
Key exclusion criteria (1 listed)
- Blood thinner, hydrocephalus , previous brain infarcts, encephalopathy, birth trauma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Following S100B and NSE in head traumaAlso: S100B NSEFollowing S100B and NSE in head trauma in correlation with Head CT and post concussion syndrome and Lisat11 | Other | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biomarkers, run by University Clinical Centre of Kosova at 1 site in Albania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Albania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fatos Kelmendi (+377 44 128 255, dr.kelmendifatos@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2016.