Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12608000632392
Ethics application status
Approved
Date submitted
23/11/2008
Date registered
15/12/2008
Date last updated
15/12/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
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
Scientific title
Prophylactic effect of citicoline on the mortality and permanent neurological morbidity of the subacute and chronic subdural hematomas treated with surgery in the three and six months follow up : A double blind randomized placebo controlled clinical trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic subdural hematoma 4007 0
Condition category
Condition code
Neurological 4209 4209 0 0
Other neurological disorders
Surgery 4210 4210 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Citicoline Intravenous (IV) injection starting with 1 gram of the drug twice a day from three days before routine surgical treatment until the end of the day of operation. In the first three postoperative days the dose given was 500 milligrams twice a day and in the seven following days the patients were treated with 250 milligrams daily of citicoline intravenously.
Citicoline (cytidine_5_diphosphocholine) is an essential intermediate material in the biosynthesis of structural cellular membrane phospholipids specially phosphatidylcholine.
Citicoline is considered as a safe drug without any significant and dangerous side effects.
Intervention code [1] 3733 0
Prevention
Comparator / control treatment
The patients are randomly divided into two groups.
In the control group water for injection is prescribed as the placebo made in the same shape of the original drug ampules (citicoline).
The placebo is administered intravenously identical to the drug itself.
The frequency of administration of the placebo is two ampules of it twice a day from 3 days before routine surgical treatment until the end of the day of the operation, following by injecting one ampule of the placebo every 12 hours in the first three postoperative days and one ampule daily in the seven consequent days.
Control group
Placebo

Outcomes
Primary outcome [1] 5102 0
Full scale,verbal and performance Intelligence Quotient (IQ) according to Wechsler adult intelligence scale-revised
Timepoint [1] 5102 0
Three and six months after administration
Primary outcome [2] 5103 0
Recurrence of hematoma according to the follow up Computed Tomography (CT) scan
Timepoint [2] 5103 0
Three and six months after administration
Primary outcome [3] 5104 0
All-cause mortality rate of the cases suffering from subdural hematoma
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.
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.
Timepoint [3] 5104 0
Three and six months after administration
Secondary outcome [1] 8579 0
Academic knowledge (including reading, spelling and arithmetic) analyzed with Wide range achievement test-revised.
Timepoint [1] 8579 0
Three and six months after administration
Secondary outcome [2] 8580 0
Memory for words, stories and designs measured according to Wechsler memory scale
Timepoint [2] 8580 0
Three and six months after administration
Secondary outcome [3] 8581 0
Motor forces evaluated according to medical research council grading system.
Timepoint [3] 8581 0
Three and six months after administration

Eligibility
Key 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.
Minimum age
7 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 1397 0
Iran, Islamic Republic Of
State/province [1] 1397 0

Funding & Sponsors
Funding source category [1] 4197 0
Self funded/Unfunded
Name [1] 4197 0
Firooz Salehpoor M.D.
Country [1] 4197 0
Iran, Islamic Republic Of
Primary sponsor type
University
Name
Tabriz university of medical sciences
Address
Tabriz university of medical sciences, 19th Daneshgah street, Tabriz city ,East azerbaijan province
postal code: 51666-14766
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 3771 0
None
Name [1] 3771 0
Address [1] 3771 0
Country [1] 3771 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6255 0
regional medical research ethics committee
Ethics committee address [1] 6255 0
Ethics committee country [1] 6255 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 6255 0
Approval date [1] 6255 0
Ethics approval number [1] 6255 0
8655

Summary
Brief summary
Relatively high mortality and neurological morbidity can be attributed to chronic subdural hematomas even after accepted surgical interventions. Citicoline is a neuroprotective agent known to have positive effects in cerebrovascular surgeries and suggested to be beneficial in different cognitive disorders, traumatic brain injury and various surgical interventions.
In this study the authors examine the effect of perioperative prescription of citicoline on mortality and morbidity of chronic subdural hematomas.
The null hypothesis is perioperative prophylactic administration of citicoline has no significant effect on mortality and different neuerological morbidities of chronic subdural hematomas treated with surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29154 0
Address 29154 0
Country 29154 0
Phone 29154 0
Fax 29154 0
Email 29154 0
Contact person for public queries
Name 12311 0
Kourosh Karimi Yarandi M.D.
Address 12311 0
Imam reza hospital, 25th Golgasht street, Tabriz city, East azerbaijan province
postal code: 51666-14756
Country 12311 0
Iran, Islamic Republic Of
Phone 12311 0
+98 914 3095308
Fax 12311 0
+98) 411 3340830
Email 12311 0
[email protected]
Contact person for scientific queries
Name 3239 0
Kourosh Karimi Yarandi M.D.
Address 3239 0
Imam reza hospital, 25th Golgasht street, Tabriz city, East azerbaijan province
postal code: 51666-14756
Country 3239 0
Iran, Islamic Republic Of
Phone 3239 0
+98 914 3095308
Fax 3239 0
+98 411 3340830
Email 3239 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.