Evaluation of the effect of riluzole in improving the condition of patients with severe traumatic brain injury

Phase 3

Recruiting

• Conditions: Traumatic brain injury.; Diffuse traumatic brain injury; S06.2

• Registration Number: IRCT20191104045328N6
• Lead Sponsor: Arak University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 26 May 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Patients with severe traumatic brain injury
Impenetrable brain injury
Age over 16 years
Ability to receive medication through the mouth or nasogastric tube
Glasgow Coma Scale (GCS) less than 9
Having informed consent by family members primarily to participate in the study

Exclusion Criteria

Kidney and liver failure
History of severe brain injury (tumor or stroke)
Unidentifiable patients
Pregnancy

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Glasgow Coma Scale. Timepoint: Upon arrival of the patient, after initial resuscitation, third day, seventh day. Method of measurement: Glasgow Coma Scale Checklist.;4 score. Timepoint: Upon arrival of the patient, after initial resuscitation, third day, seventh day day. Method of measurement: 4 score checklist.;Glasgow outcome scale. Timepoint: First month after intervention, Sixth month after intervention. Method of measurement: glasgow outcome scale checklist.;Karnovsky performance status. Timepoint: First month after intervention, Sixth month after intervention. Method of measurement: Karnovsky performance status checklist.;Mini Mental State Test. Timepoint: First month after intervention, Sixth month after intervention. Method of measurement: Mini Mental State Test.;Disability Rating Scale. Timepoint: First month after intervention, Sixth month after intervention. Method of measurement: Disability Rating Scale.