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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05767502
Other study ID # 2019-KAEK-140
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 20, 2023
Est. completion date June 1, 2024

Study information

Verified date March 2023
Source Uludag University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In this study, it is aimed to determine the prognostic value of GCS-P and the GCS-P score, which is formed by assigning a verbal score, in patients with traumatic brain injury, where all parameters can be evaluated. In the model to be created, a new total score will be obtained with Motor score + Eye Response + assigned verbal Score-Pupil score and this score will be compared with GCS and GCS-Pupil score.


Recruitment information / eligibility

Status Recruiting
Enrollment 199
Est. completion date June 1, 2024
Est. primary completion date March 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Admitted to hospital due to traumatic brain injury, - 18 years and older, - who were alive at the time of admission, - Patients whose GCS and pupil reactivity can be evaluated completely. Exclusion Criteria: - Younger than 18, - Not alive at the time of admission, - Patients whose GCS score and pupil reactivity are not correctly evaluated (facial trauma, past eye diseases or eye defects, etc.).

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
GCS-Pupil score
GCS+attributed verbal score- Step 1 to obtain pupillary score: Patients with a motor (M) and eye-opening response (E) total score between 2 and 6 are assigned a verbal score of +1 Patients with an M+E score of 7 are assigned a verbal score of +2 Patients with an M+E score of 8-9 are assigned a verbal score of +4 Patients with an M+E score of 10 are assigned a verbal score of +5 GCS+attributed verbal score- Step 2 to obtain the pupillary score: The total score is obtained by subtracting the pupil score from the score obtained in the 1st step. Pupil score is scored as follows; 0 points if both pupils react to light, 1 point if a pupil does not react to light and has anisocoria, 2 points if both pupils do not react to light

Locations

Country Name City State
Turkey Bursa City 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 MORTALITY Death of the patient while in the hospital From admission to discharge, an average of 1 weeks
Primary MORBIDTIY Patients with a Glasgow Outcome score of 2 and 3 (Each patient can get 1-5 points from the Glasgow Outcome score. A low score indicates a negative result. From admission to discharge, an average of 1 weeks
Secondary MORTALITY Death within 3 months after hospital discharge 3 months after hospital discharge
Secondary MORBIDITY A Glaskow Coma Outcome Score of 2 and 3 at the end of 3 months after discharge from the hospital. (Each patient can get 1-5 points from the Glasgow Outcome score. A low score indicates a negative result) 3 months after hospital discharge
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