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The Effect of Cyclosporine on Head Trauma

Phase 2
Conditions
Diffuse Axonal Injury.
Diffuse Brain Injury
Registration Number
IRCT2013011712164N1
Lead Sponsor
Vice chancellor for research, Isfahan University of Medical Science
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
100
Inclusion Criteria

Inclusion criteria are:
Age between 16 and 75 years; GCS score less than 10 in 24 hours of admission; Complete consent form; ßHCG is negative and no pregnant patients.
Exclusion criteria are:
Negative brain stem reflex response; Patients with immune deficiency; Liver and kidney diseases; Penetrative brain injury; Multiple trauma; Past medical history of cancer; And patients that need emergency surgery; Pregnant women

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
evel of Consciousness. Timepoint: 1day, 3month, 6month. Method of measurement: GCS, GOS-E, MMSE.
Secondary Outcome Measures
NameTimeMethod
iver Function Tests. Timepoint: 12hour, 24hour, 36hour, 48hour, 4day, 7day, 3month, 6month. Method of measurement: AST(Aspartat Aminotransferase), ALT(Alanine Aminotransferase), ALP(Alkaline Phosphatase).
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