Randomized double blind placebo control trial. Inclusion criteria: Patients undergone neurosurgery with suggested diagnosis of glial tumor. Exclusion criteria: Atorvastatin contraindications: atorvatatin sensitivity, active hepatic disease, pregnancy and lactation. elevated liver enzymes; serious adverse reaction induced by atorvastatin; severe renal or failure; having infectious disease; use of atorvastatin before the study; pathology report of other type of tumors instead of glioma; serious interaction between patients medication with atorvastatin; MAP< 70 mmHg; Na<130mEq/L; Hematocrit<28%. The main goal of study is the evaluation of atorvastatin effects on plasma MMP 9 concentration in neurosurgical- induced brain injuries after glial tumor resection. These Forty four patients with completion of inclusion and exclusion criteria will be randomly included in one of two groups (atorvastatin or placebo) and will be treated with atorvastatin or placebo in addition to typical therapeutic regimen. Blood samples for detection of MMP-9 plasma concentration will be prepared at beginning of study before surgery, 24 hour and two weeks after the surgery.Plasma MMP9 concentration will assessed by ELISA kit. Karnofsky Performance Scale will assessed before and 2 months after the surgery. At last result will be analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201203039196N1
Registration date:2012-03-17, 1390/12/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-03-17, 1390/12/27
Registrant information
Name
Niayesh Mohebbi
Name of organization / entity
TUMS
Country
Iran (Islamic Republic of)
Phone
+98 21 8841 3590
Email address
nmohebbi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-03-15, 1390/12/25
Expected recruitment end date
2012-09-15, 1391/06/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of atorvastatin effects on plasma MMP 9 concentration in neurosurgical- induced brain injuries after glial tumor resection
Public title
Atorvastatin neuroprotective effects in glial tumor surgey
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients undergone neurosurgery with suggested diagnosis of glial tumor. Exclusion criteria: Atorvastatin contraindications: atorvatatin sensitivity, active hepatic disease, pregnancy and lactation. elevated liver enzymes; serious adverse reaction induced by atorvastatin; severe renal or hepatic failure; having infectious disease; use of atorvastatin before the study; pathology report of other type of tumors instead of glioma; serious interaction between patients medication with atorvastatin; MAP< 70 mmHg; Na<130mEq/L; Hematocrit<28%.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences Ethics Committee
Street address
Poursina St, Enghelab St.
City
Tehran
Postal code
Approval date
2012-02-26, 1390/12/07
Ethics committee reference number
15799
Health conditions studied
1
Description of health condition studied
Glial tumor
ICD-10 code
C71.9
ICD-10 code description
Malignant neoplasm of brain, Brain, unspecified
Primary outcomes
1
Description
MMP-9
Timepoint
At the beginning of study, before surgery, 24 hour and two weeks after the surgery
Method of measurement
Lab test
2
Description
Karnofsky Performance Scale
Timepoint
Before and 2 months after the surgery
Method of measurement
Karnofsky Performance Scale criteria
Secondary outcomes
empty
Intervention groups
1
Description
In atorvastatin (Intervention) group: Atorvastatin, tablet 40 mg, twice daily, one week before surgery and two weeks after the surgery.
Category
Treatment - Drugs
2
Description
In placebo (Control) group: Placebo of atorvastatin, tablet 40 mg, twice daily, one week before surgery and two weeks after the surgery.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran University of Medical sciences affiliated hospitals
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Vice-Chancellor for Research
Street address
Sixth floor, Tehran University of Medical Sciences, Ghods street, Keshavarz blv.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Kheirollah Gholami
Position
Professor
Other areas of specialty/work
Street address
Clinical pharmacy department, School of pharmacy, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 8884 9016
Fax
Email
khgholami@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Alireza Khoshnevisan
Position
Assistance professor
Other areas of specialty/work
Street address
Neurosurgery Department, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 8822 0040
Fax
Email
akhoshnevisan@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Niayesh Mohebbi
Position
Resident of Clinical Pharmacy
Other areas of specialty/work
Street address
Clinical Pharmacy department, School of Pharmacy, Tehran University of Medical Sciences, Enghelab Ave
City
Tehran
Postal code
Phone
+98 21 8884 9016
Fax
Email
niayesh_mohebbi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)