Assignment of the Verbal Component Score and Addition of Pupil Reaction to the Glasgow Coma Scale

Brain Injuries, Traumatic Clinical Trial

Official title:

Investigation of the Effect of Assigning Verbal Component Score to Glasgow Coma Scale in Patients With Traumatic Brain Injury and Adding Pupil Reaction to Determining Mortality/Morbidity in Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05767502
• Other study ID #: 2019-KAEK-140
• Status: Recruiting
• 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
• 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.).

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic

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