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IRCT20190725044331N1 IRCT 2019-09-06 Ahvaz University of Medical Sciences Evaluation the Effect of N-acetylcysteine in Traumatic Brain Injury Patients with Moderate to Severe Consciousness Level Admitted to Intensive Care Unit Evaluation the Effect of N-acetylcysteine as a Neuroprotective in Traumatic Brain Injury Patients with Moderate to Severe Consciousness Level Admitted to Intensive Care Unit 2019-08-23 anticipated 28 Complete https://irct.ir/trial/41879 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Individuals are randomly divided into two groups based on simple randomization method using random digits table. In this method, a collection of non-template numbers is randomly generated and arranged as a table. Even numbers for the intervention group and the odd numbers for the control group are considered. According to the number of patients, they are randomly assigned to one of the treatment or intervention groups, Blinding description: Responsible for collecting data and data analyzer are blinded to patient's group. 3 Traumatic Brain Injury (TBI). Intervention 1: Intervention group: Oral N-acetylcysteine with dose of 600 mg will be prescribed twice a day. Intervention 2: Control group: Placebo (medical plaster powder) with dose of 600 mg will be prescribed twice a day. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is "No more information"
public Mehdi Ebrahimi Monfared
Golestan Hospital, Farvardin Ave.
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3374 3037 ebrahimi.mn@yahoo.com Ahvaz University of Medical Sciences scientific Farhad Soltani
Golestan Hospital, Farvardin Ave.
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3374 3037 soltani-f@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Age range 18 – 65 year Consciousness level 9-12 based on Glasgow Coma Scale (GCS) Transferred to intensive care unit less than 24 hours after trauma 18 years 65 years Both Allergic reaction to N-acetylcysteine Stay in intensive care unit less than 72 hours Pregnant patients Associated spinal cord injury Craniotomy History of autoimmune diseases S06.9 Unspecified intracranial injury Treatment - Drugs Placebo Intervention group: Oral N-acetylcysteine with dose of 600 mg will be prescribed twice a day. Control group: Placebo (medical plaster powder) with dose of 600 mg will be prescribed twice a day. Consciousness level. Timepoint: Upon arrival, two days,1, 2, 3 and 4 weeks after the drug administration. Method of measurement: Glasgow Coma Scale (GCS). Duration of hospitalization. Timepoint: Duration of admission to discharge. Method of measurement: day. The time required for mechanical ventilation. Timepoint: Duration of hospitalization. Method of measurement: day. Rate of mortality. Timepoint: Up to 4 weeks after the drug administration. Method of measurement: The number of patients who died. Ahvaz University of Medical Sciences Approved 2019-02-02 Ethics committee of Ahvaz University of Medical Sciences Research deputy, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd. Ahvaz Khouzestan Iran (Islamic Republic of)