Effects of atorvastatin in patients with traumatic brain injury

Effects of atorvastatin on reduction of size of brain contusions and peri contusional edema and prognosis of patients with moderate and severe traumatic brain injury

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2015050920353N2

Enrollment

Registered

2015-08-28

Start date

2015-06-01

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Brain contusion. Focal brain injury

Interventions

Placebo

Group 1: ?Atorvastatin 20 mg tab every 12hours for 10 days

Group 2 : Placebo tablet,20mg every 12 hours for 10 days

Intervention 1: Group 1: ?Atorvastatin 20 mg tab every 12hours for 10 days. Intervention 2: Group 2 : Placebo tablet,20mg every 12 hours for 10 days.

Treatment - Drugs

Eligibility

Sex/Gender

All

Age

18 Years to 74 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Documented closed head injury; Age between 18 and 75 years; Having brain contusions on initial brain CT scan; Taking the first dosage of medication within first 10 hours of trauma event; GCS:5-13 without influence of sedations upon admission; Obtaining written informed consent from legally authorized representative Exclusion criteria: Having a lesion on brain CT which urges a surgical evacuation at any time of hospital admission (Surgical EDH, SDH, ICH or midline shift>5mm and decompressive craniectomy); Spinal cord injury or spinal column instability with neurologic deficit; Penetrating brain injury; Any blood glucose under 50mg/dL or over 500mg/d; Severe renal disorder from past history or Cr>2.5 or patients on hemodialysis; Severe liver disease from past history or total bilirubin above 1.5 times of normal value; INR>1.6; Systolic BP below 90mmHg on admission without respond to fluid resuscitation; Pregnant women or a positive pregnancy test or those who intend to breastfeed during study days; Associated severe non-survivable injury; History of previous brain problems (Tumor, infections, strokes, …); Usage of warfarin, heparin, clopidogrel, LMWH within 72 hours prior to traumatic event

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Brain contusion volume. Timepoint: On admission, day 5 and 10 after intervention. Method of measurement: CT-volumetry of brain contusions.;Final outcome(GOS). Timepoint: 6months after intervention. Method of measurement: Glasgow Outcome Scale (GOS) which is from 1 to 5 ( 1=death, 2=vegetative state, 3=severe disability, 4=moderate disability, 5= good recovery). This is a standard scoring scale for stating final outcome in patients with traumatic brain injury.;Volume of pericontusional edema. Timepoint: On admission, day 5 and 10 after intervention. Method of measurement: CT-volumetry of pericontusional edema.	—

Measure

Time frame

Brain contusion volume. Timepoint: On admission, day 5 and 10 after intervention. Method of measurement: CT-volumetry of brain contusions.;Final outcome(GOS). Timepoint: 6months after intervention. Method of measurement: Glasgow Outcome Scale (GOS) which is from 1 to 5 ( 1=death, 2=vegetative state, 3=severe disability, 4=moderate disability, 5= good recovery). This is a standard scoring scale for stating final outcome in patients with traumatic brain injury.;Volume of pericontusional edema. Timepoint: On admission, day 5 and 10 after intervention. Method of measurement: CT-volumetry of pericontusional edema.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactNima Derakhshan

Shiraz University of Medical Sciences

derakhshn@sums.ac.ir+98 71 3647 4259

Outcome results

None listed

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