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Studying the effect of low-dose (10 mg) lipid-lowering drug administration on plasma levels of coagulation factors and white blood cells in patients with traumatic brain injury

Studying the effect of low-dose atorvastatin (10 mg) on plasma fibrinogen levels and white blood cell counts in patients with traumatic brain injury

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250803066738N1
Enrollment
70
Registered
2025-08-07
Start date
2025-08-23
Completion date
Unknown
Last updated
2025-08-19

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

Conditions

traumatic brain injury. Diffuse traumatic brain injury

Interventions

Intervention 1: Intervention group: they will receive standard care for treatment during the hospitalization period, as well as atorvastatin 10 mg orally or via NG tube from the first day of hospitali

Sponsors

Kerman University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Diagnosis of traumatic brain injury (TBI) of mild to severe severity (based on GCS). ICU admission for at least 72 hours (to ensure adequate monitoring). No use of atorvastatin in the 3 months prior to hospitalization. No history of liver disease or elevated liver enzymes (ALT/AST > 3 times normal).

Exclusion criteria

Exclusion criteria: Concomitant use of drugs that interact with atorvastatin (such as some antibiotics, antifungals). Patients with GCS = 3 History of allergy to atorvastatin or any statin. History of statin-induced myopathy or rhabdomyolysis. TBI caused by suicide or non-accidental injuries (for moral and psychological reasons). Need for emergency surgery other than craniotomy (e.g., abdominal or thoracic surgery). Receiving strong anti-inflammatory medications (such as high-dose corticosteroids) within 7 days prior to the study

Design outcomes

Primary

MeasureTime frame
Fibrinogen level. Timepoint: At the beginning of the study and 14 days later. Method of measurement: Blood test.;White blood cell count. Timepoint: At the beginning of the study and 14 days later. Method of measurement: Blood test.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmin Soleimani Mohammadi

Kerman University of Medical Sciences

Soleimanyamin70@gmail.com+98 34 3223 5011

Outcome results

None listed

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