Evaluation of Riluzole efficacy on cognitive and functional outcome of severe traumatic brain injury patients

Evaluation of Riluzole efficacy on cognitive and functional outcome of severe traumatic brain injury patients

This study is a double-blind trial with parallel groups in which 50 patients with traumatic brain injury are divided into two identical intervention and control groups using block randomization method.

This study is a two-blind trial in which 50 patients with severe traumatic brain injury referred to Vali Asr Hospital in Arak are admitted to the study. These people are divided into two equal groups of intervention and control using the block randomization method. In the intervention group, riluzole was administered for 2 weeks at a dose of 500 mg every 12 hours, preferably during the first 12 hours after trauma and at the first opportunity after the ability to eat by mouth. In the control group, distilled water is used instead of riluzole. Finally, The two groups are compared in terms of main outcomes.

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 less than 9, Having informed consent by family members primarily to participate in the study Non-entry criteria: Kidney and liver failure, History of severe brain injury, Unidentifiable patients and Pregnancy .

Intervention group: The treatment protocol included administration of the drug (riluzole) for 2 weeks, at a dose of 500 mg every 12 hours, preferably during the first 12 hours after trauma and at the first opportunity after the ability to eat by mouth. Control group: Distilled water will be prescribed instead of riluzole

Glasgow Coma Scale, 4 scores, Karnovsky performance status, Glasgow outcome scale, Mini Mental State Test, Disability Rating Scale

Participants are assigned to two intervention and control groups, respectively, based on the randomization sequence that will be generated beforehand. This sequence is unpredictable and its arrangement is completely random. Block randomization method with 8 blocks will be used to allocate samples. Thus, using block numerical random number generation software, a randomization sequence proportional to the sample size required for the two groups will be generated. Initially, all cases in which the two letters A and B can be arranged in blocks of 8 are produced. A block is then randomly selected from the blocks and the layout pattern in that block will be used to assign participants. This block will then be placed in the main container and another block will be selected again. All this will be done with software called Sealed Envelope. With this method, concealment will also be observed. The concept of concealment is to unpredictably assign individuals to groups. In fact, the researcher will not be able to predict which group the next person will be in.

In the process of blinding, the treating physician and the patient are blind and the trained assistant is in the process of studying. The person completing the questionnaire is the same trained assistant or facilitator.

After conducting this study and analytical studies on it, only a part of the data such as information about the main outcome and patient demographic information will be published to the researchers who do the necessary correspondence with the person in charge of this study.

Access will be from 2022/4/20 to 2026/4/20 for 4 years.

University researchers

If there are any further questions

Dr Aidin Shakeri

Letter writing should be done with professors and universities.