The effect of oral simvastatin on the outcome of patients with severe traumatic brain injury

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180802040668N1

Enrollment

Registered

2018-10-25

Start date

2018-10-08

Completion date

Unknown

Last updated

2019-01-14

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

Conditions

Severe traumatic brain injury.

Interventions

Intervention 1: Intervention group: Intervention group: In addition to supportive therapies, daily treatment with simvastatin will be administered at a dose of 40 mg per day for 10 days. Intervention

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Patients with severe traumatic brain injury Non-use of corticosteroids and statins and NSAIDs Not having an allergy to statins Not having a history of autoimmune, cardio, respiratory, neuromuscular, liver or kidney disease

Exclusion criteria

Exclusion criteria: Space-occupying lesion in the skull, including hematoma and ... GCS higher than 8 or GCS = 3 on admission Age> 60 and <18 years Syndrome organ trauma that requires surgical intervention. trauma of the limbs that requires surgical intervention. History of poisoning or drug use sepsis during the first 72 hours of admission

Design outcomes

Primary

Measure	Time frame
GCS, APACHEE2, ISS. Timepoint: The beginning of the study, Day 3 and Day 10 after starting treatment. Method of measurement: questionnaire.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSajad Shafiei

Sari University of Medical Sciences

sajad.shafiee@gmail.com+98 113336700

Outcome results

None listed

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