Brain Injuries, TraumaticNCT05419739
Prognostic Value of Pediatric GCS-Pupil Score in Pediatric Patients With Traumatic Brain Injury
An observational study of Brain Injuries, Traumatic, run by Uludag University at 1 site in Turkey (Türkiye).
Trial summary
There are studies reporting that the survival rate in pediatric patients with abnormal pupillary response is 23% and that pupillary response is effective on mortality and patient outcomes. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Brain Injuries, Traumatic
- What is being tested?
- Glasgow coma scale
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jul 2022to Jul 2023
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric patients younger than 18 years with traumatic brain injury
Who may be able to join
- Be under the age of 18,
- Not having mental and motor developmental retardation,
- Having had a traumatic brain injury,
- Alive at admission and followed up for at least 24 hours
Who cannot join
- Eye trauma or severe facial trauma that will affect the assessment,
- Those under deep sedation,
- Those who have been administered drugs (Atropine and mydriatic) that will affect the pupillary response.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bursa Provincial Health Directorate University of Health Sciences Bursa Yuksek Ihtisas Training and Research Hospital
Bursa, 16000
HOSPITAL ethics committee, +90 224 295 50 00, bursayuksekihtisaseah@saglik.gov.tr
About this study
There are studies reporting that the survival rate in pediatric patients with abnormal pupillary response is 23% and that pupillary response is effective on mortality and patient outcomes. Studies in the literature examining the effect of pupillary response on mortality and outcome in pediatric patients with traumatic brain injury reported that bilaterally dilated pupils were associated with a higher mortality rate.
Considering the literature results, we believe that obtaining the GCS-Pupil score by combining GCS and pupillary reaction in pediatric patients with traumatic brain injury will be effective in predicting patient outcomes.
Read the detailed description
Obtaining a GCS-Pupil score using the total GCS score: 0 points are given for pupillary reaction if both pupils react to light, 1 point if one pupil does not react to light, and 2 points if both pupils do not react to light. Total GCS-P score is calculated by the formula of Eye Response + Verbal Response + Motor Response - Pupil Reaction and scores between 1-15.
In the study, the worst GCS and current pupillary light reaction score in the first 24 hours will be evaluated.
- Conditions
- Brain Injuries, Traumatic
- Being tested
- Glasgow coma scale
- Keywords
- Brain traumatic, GCS-Pupil score, Pediatric
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glasgow coma scaleOther
Also called Pediatric Cerebral Performance Category Scoring System
This scale, which consists of three parameters, includes the best eye response (1-4 points), the best verbal response (1-5 points), and the best motor response (1-6 points). Total score; It is calculated as Eye Response + Verbal Response + Motor Response and takes a value between 3-15 points. The severity of head trauma is evaluated in three categories: mild (GCS 13-15 points), moderate (GCS 9-12 points), and severe (GCS ≤ 8 points).
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Children under 18 years of age with traumatic brain injury Receives: Other: Glasgow coma scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death rate
Death
Measured: one year
Secondary outcomes (1)
Adverse functional outcomes
severely crippled or vegetative condition
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study startJul 2022 (estimated)
- Primary completionJul 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Injuries, TraumaticStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AKİF BULUT, Uludag University
- Investigators
- AKİF BULUT, MSc, Principal investigator, Uludag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05419739
- Sponsor's protocol ID
- 2011-KAEK-25 2022/04-08
- Status last verified
- Jun 2022
- First submitted
- 10 Jun 2022
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Pediatric GCS-Pupil Score in Pediatric Patients With Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT05419739
- Acronym / sponsor ID
- 2011-KAEK-25 2022/04-08
- Conditions
- Brain Injuries, Traumatic
- Keywords
- Brain traumatic, GCS-Pupil score, Pediatric
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- Jul 2022 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 15 Jun 2022 (actual)
- 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.
There are studies reporting that the survival rate in pediatric patients with abnormal pupillary response is 23% and that pupillary response is effective on mortality and patient outcomes. Studies in the literature examining the effect of pupillary response on mortality and outcome in pediatric patients with traumatic brain injury reported that bilaterally dilated pupils were associated with a higher mortality rate.
Considering the literature results, we believe that obtaining the GCS-Pupil score by combining GCS and pupillary reaction in pediatric patients with traumatic brain injury will be effective in predicting patient outcomes.
Detailed description
Obtaining a GCS-Pupil score using the total GCS score: 0 points are given for pupillary reaction if both pupils react to light, 1 point if one pupil does not react to light, and 2 points if both pupils do not react to light. Total GCS-P score is calculated by the formula of Eye Response + Verbal Response + Motor Response - Pupil Reaction and scores between 1-15.
In the study, the worst GCS and current pupillary light reaction score in the first 24 hours will be evaluated.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Glasgow coma scaleChildren under 18 years of age with traumatic brain injury |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients younger than 18 years with traumatic brain injury
Key inclusion criteria (4 listed)
- Be under the age of 18,
- Not having mental and motor developmental retardation,
- Having had a traumatic brain injury,
- Alive at admission and followed up for at least 24 hours
Key exclusion criteria (3 listed)
- Eye trauma or severe facial trauma that will affect the assessment,
- Those under deep sedation,
- Those who have been administered drugs (Atropine and mydriatic) that will affect the pupillary response.
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 |
|---|---|---|
| Glasgow coma scaleAlso: Pediatric Cerebral Performance Category Scoring SystemThis scale, which consists of three parameters, includes the best eye response (1-4 points), the best verbal response (1-5 points), and the best motor response (1-6 points). Total score; It is calculated as Eye Response + Verbal Response + Motor Response and takes a value between 3-15 points. The severity of head trauma is evaluated in three categories: mild (GCS 13-15 points), moderate (GCS 9-12 points), and severe (GCS ≤ 8 points). | Other | Group 1 |
Primary outcome
Death rate
Time frame: one year
Death
1 secondary outcome
Adverse functional outcomes
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared with other researchers.
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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.
AKİF BULUT, MSc principal investigator
Uludag University
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 Brain Injuries, Traumatic, run by Uludag University at 1 site in Turkey (Türkiye).
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 4 inclusion and 3 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 22 Jun 2022. 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 Turkey (Türkiye). 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 AKİF BULUT, MSc (+90 546 872 28 72, akifblt23@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death rate (time frame: one year). 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 22 Jun 2022.