Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05419739
Other study ID # 2011-KAEK-25 2022/04-08
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date July 2022
Est. completion date July 2023

Study information

Verified date June 2022
Source Uludag University
Contact AKIF BULUT, MSc
Phone +90 546 872 28 72
Email akifblt23@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 128
Est. completion date July 2023
Est. primary completion date July 2023
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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.

Study Design


Intervention

Other:
Glasgow coma scale
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).

Locations

Country Name City State
Turkey Bursa Provincial Health Directorate University of Health Sciences Bursa Yuksek Ihtisas Training and Research Hospital Bursa

Sponsors (1)

Lead Sponsor Collaborator
Uludag University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Death rate Death one year
Secondary Adverse functional outcomes severely crippled or vegetative condition one year
See also
  Status Clinical Trial Phase
Recruiting NCT04111549 - GOALS Cognitive Training Delivered to Aging Veterans in Person or Via Telehealth N/A
Recruiting NCT05097261 - Ketamine in Acute Brain Injury Patients. Phase 4
Completed NCT03504709 - REsting and Stimulus-based Paradigms to Detect Organized NetworkS and Predict Emergence of Consciousness
Recruiting NCT03899532 - Remote Ischemic Conditioning in Traumatic Brain Injury N/A
Completed NCT05057377 - Estimating Highest Capacity Performance During Evaluation of Walking for Individuals With Traumatic Brain Injury
Withdrawn NCT02776488 - Exogenous Sodium Lactate Infusion in Traumatic Brain Injury (ELI-TBI) Phase 2
Completed NCT02426749 - Treatment and Recovery Monitoring of Post TBI Symptoms N/A
Completed NCT01339702 - The EPIC Project: Impact of Implementing the EMS Traumatic Brain Injury Treatment Guidelines
Recruiting NCT05977270 - The Effects of Lifebloom One on Physical Activity After Acquired Brain Injury N/A
Recruiting NCT04666766 - Detecting Traumatic Intracranial Hemorrhage With Microwaves and Biomarkers N/A
Active, not recruiting NCT04559724 - Gait Training Through a Novel Over-ground Wearable Robotic System in People With Pyramidal Hemisyndromes N/A
Not yet recruiting NCT04515420 - The Influence of Noradrenaline on Coagulation and Fibrinolysis in Severe Isolated Brain Injury
Not yet recruiting NCT05569993 - Glutamine and Traumatic Brain Injury Early Phase 1
Recruiting NCT04331392 - Online Memory Intervention for Individuals With Traumatic Brain Injury N/A
Completed NCT03727737 - Efficacy of Repetitive Transcranial Magnetic Stimulation for Improvement of Memory in Older Adults With TBI N/A
Completed NCT03153397 - Effect of Prebiotic Fiber- Enriched (scFOS) Enteral Feeding on the Microbiome in Neurological Injury Trauma Patients (PreFEED Microbiome Trial) N/A
Completed NCT01336413 - Neuroactive Steroids and Traumatic Brain Injury (TBI) in OEF/OIF Veterans Phase 2
Completed NCT02004080 - CREACTIVE - Collaborative REsearch on ACute Traumatic Brain Injury in intensiVe Care Medicine in Europe
Completed NCT04957563 - Clinical Utility of Olfactory Rehabilitation: Treatment for Pacients With Neurosensorial Anosmia N/A
Completed NCT05179330 - Visual Feedback in Lower Limb Rehabilitation N/A