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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190725044331N1

Enrollment

Registered

2019-09-06

Start date

2019-08-23

Completion date

Unknown

Last updated

2019-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury (TBI). Unspecified intracranial injury

Interventions

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 b

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMehdi Ebrahimi Monfared

Ahvaz University of Medical Sciences

ebrahimi.mn@yahoo.com+98 61 3374 3037

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026