Prophylactic effect of citicoline on the mortality and permanent neurological morbidity of the subacute and chronic subdural hematomas treated with surgery: A double blind randomized placebo controlled clinical trial
Completed
- Conditions
- chronic subdural hematomaNeurological - Other neurological disordersSurgery - Other surgery
- Registration Number
- ACTRN12608000632392
- Lead Sponsor
- Tabriz university of medical sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Patients with subacute and chronic subdural hematoma who were conscious and oriented at the time of admission with ages more than 7 years.
Exclusion Criteria
Patients who were not conscious and oriented (Glasgow Coma Scale (GCS)<15), were less than 7 years old and whose hematomas were recurrent ones.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Full scale,verbal and performance Intelligence Quotient (IQ) according to Wechsler adult intelligence scale-revised[Three and six months after administration];Recurrence of hematoma according to the follow up Computed Tomography (CT) scan[Three and six months after administration];All-cause mortality rate of the cases suffering from subdural hematoma<br>Relatives of all of the dead cases should provide a copy of the written document of the cause of death by the physician confirming his/her death or a forinsic medicine specialist.<br>In cases of absence of such documents the whole files related to the episode of admission leading to death are carefully read and occuring death along with it's cause is recognized according to that.[Three and six months after administration]
- Secondary Outcome Measures
Name Time Method Academic knowledge (including reading, spelling and arithmetic) analyzed with Wide range achievement test-revised.[Three and six months after administration];Memory for words, stories and designs measured according to Wechsler memory scale[Three and six months after administration];Motor forces evaluated according to medical research council grading system.[Three and six months after administration]