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

March 10, 2023 updated by: AKİF BULUT, Uludag University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

199

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Bursa, Turkey, 16000
        • Recruiting
        • Bursa City Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

When α: 0.05 β: 0.20 and the acceptable difference between models were selected as 10% using the G-Power program, the number of patients to be included in the study was determined as 199.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MORTALITY
Time Frame: From admission to discharge, an average of 1 weeks
Death of the patient while in the hospital
From admission to discharge, an average of 1 weeks
MORBIDTIY
Time Frame: From admission to discharge, an average of 1 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
MORTALITY
Time Frame: 3 months after hospital discharge
Death within 3 months after hospital discharge
3 months after hospital discharge
MORBIDITY
Time Frame: 3 months after hospital discharge
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uludag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2023

Primary Completion (Anticipated)

March 1, 2024

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

February 28, 2023

First Submitted That Met QC Criteria

March 10, 2023

First Posted (Actual)

March 14, 2023

Study Record Updates

Last Update Posted (Actual)

March 14, 2023

Last Update Submitted That Met QC Criteria

March 10, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-KAEK-140

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Sharing of study data is not allowed in our country.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Brain Injuries, Traumatic

Clinical Trials on GCS-Pupil score

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malawi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe