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

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 18 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

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.

Trial locations and contacts

1 site in 1 country.

About this study

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

Conditions

Brain Injuries, Traumatic

Being tested

GCS-Pupil score

Keywords

GCS, GCS-Pupil score, Brain trauma, Consciousness

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.

• GCS-Pupil scoreDiagnostic test

  Also called GCS+attributed verbal score- 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

What is being measured

The primary outcome is the main question the study is designed to answer.

1. MORTALITY

   Death of the patient while in the hospital

   Measured: From admission to discharge, an average of 1 weeks

2. 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.

   Measured: From admission to discharge, an average of 1 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted14 Mar 2023
2. Study start20 Feb 2023
3. Primary completion1 Mar 2024 (estimated)
4. Study completion1 Jun 2024 (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.