Evaluation the Effect of N-acetylcysteine in Traumatic Brain Injury Patients with Moderate to Severe Consciousness Level Admitted to Intensive Care Unit

Phase 3

Recruiting

• Conditions: S06.9; Traumatic Brain Injury (TBI).; Unspecified intracranial injury

• Registration Number: IRCT20190725044331N1
• Lead Sponsor: Ahvaz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 7 October 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.