Granulocyte-Colony Stimulating Factor Treatment for Acute Ischemic Stroke: A Randomized Control Trial Study Assessing Clinical and Radiological Responses
Objectives: This project is a Triple- Blind Randomized Control Trial Study assessing clinical and radiological responses in acute ischemic stroke referred to Imam khomeini Hospital.
Design: Neural stem cells and mature neurons have G-CSF receptor. Stimulation of G-CSF receptor leads to inhibition of apoptosis, neuroprotection against ischemia and cytotoxic agents, and stimulation of bone marrow and neural stem cells. Several experimental models confirmed above findings which results in this hypothesis that G-CSF may be effective in ischemic stroke. Confirmation of this idea can be an effective step in the treatment of cerebral ischemia.
Setting and conduct: this study is a triple-blind randomized clinical trial which evaluates therapeutic effects of G-CSF in acute stroke patients. Interventions: After verifying the consensus form, intervention group and control group will receive G-CSF and placebo, respectively. All patients will receive standard treatments verifying by accepted guidelines.
Participants including major eligibility criteria: Inclusion Criteria: Acute ischemic stroke in the territory of middle cerebral artery which is confirmed by imaging. In addition, less than 24 hours from the beginning of stroke has been lost.
Exclusion criteria include: Hypersensitivity to E coli proteins or G-CSF; History of cancer; History of chronic diseases; More than 2/3 of MCA territory; Pregnancy; and lacunar infarction.
Intervention: Drug and placebo, and Sampling
Major outcome: clinical (Bartle scale), radiological (volume of lesion), and biochemical (IL-6 ...) indexes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201208081584N2
Registration date:2012-09-16, 1391/06/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-09-16, 1391/06/26
Registrant information
Name
Mohammad Hossein Harirchian
Name of organization / entity
Tehran University of Medical Science, Iranian Center of Neurological Research
Country
Iran (Islamic Republic of)
Phone
+98 21 8873 3731
Email address
harirchm@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Teharn University of Medical Sciences and Pooyesh Darou Company are sponsors of this clinical trial.
Expected recruitment start date
2012-09-01, 1391/06/11
Expected recruitment end date
2014-09-01, 1393/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Granulocyte-Colony Stimulating Factor Treatment for Acute Ischemic Stroke: A Randomized Control Trial Study Assessing Clinical and Radiological Responses
Public title
Granulocyte-Colony Stimulating Factor Treatment for Acute Ischemic Stroke: A Randomized Control Trial Study Assessing Clinical and Radiological Responses
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Critria:
Age: 40-80; stroke was confirmed by DWI; less than 24 hours of beginning of stroke; NIHSS scale: 4-24; Stroke in MCA territory
Exclusion critria:
hypersensitivity to E coli proteins or G-CSF; History of cancer; History of severe renal, liver and hematological diseases; More than 2/3 of MCA territory; Pregnancy; The patient is candidate for rTPA; Acute ICH; Lacunar infarction
Age
From 40 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Ethics committee of Tehran University of Medical Sciences, 5th floor, Ghods St, Tehran University of Medical Sciences, Tehran, Iran
City
Tehran
Postal code
Approval date
2012-09-22, 1391/07/01
Ethics committee reference number
90-04-54-15797-53565
Health conditions studied
1
Description of health condition studied
Acute Ischemic Stroke
ICD-10 code
G46.0
ICD-10 code description
A stroke is caused by the interruption of the blood supply to the brain, usually because a blood vessel is blocked by a clot. This cuts off the supply of oxygen and nutrients, causing damage to the brain tissue.
Primary outcomes
1
Description
Clinical sign and symptoms
Timepoint
first week, 2nd week, 1st and 2nd and 3rd months
Method of measurement
NIHSS scale,Barthel Index Scale Score, modified rankin scale
Secondary outcomes
1
Description
Lesion volume
Timepoint
one week
Method of measurement
Brain MRI(DWI and PWI)
Intervention groups
1
Description
Case group receives G-CSF, 10 microgram per kilogram of body weight subcutaneously. However the first dose will be prescribed via intra venous line.
Category
Treatment - Drugs
2
Description
Control group will receive placebo (normal saline, 0.1 ml per kg of body weight). Participation in the study doesn’t produce any avoidance for receiving standard treatment of stroke.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Iranian Center of Neurological Researches
Full name of responsible person
Dr Mohammad Hossein Harirchian
Street address
Iranian Center of Neurological Researches, Imam khomeini Hospital,Blvd Keshavarz, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Dr Fotuhi
Street address
Vice chancellor for research, Tehran University of Medical Sciences, Ghods Street, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
90-04-54-15797
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran University of Medical Sciences
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Pooyesh darou Company
Full name of responsible person
Dr Tabatabaee
Street address
Pooyesh darou, on the opposite side of Center of Growth and Technology, after unknown martyr highway, north kargar St, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pooyesh darou Company
Proportion provided by this source
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 Mohammad Hossein Harirchian
Position
Professor of Neurology
Other areas of specialty/work
Street address
Iranian Center of Neurological Researches, Imam Khomeini Hospital, Blvd Keshavarz, Tehran, Iran
City
Tehran
Postal code
1419733141
Phone
+98 21 6119 2424
Fax
Email
harirchm@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 Mohammad Hossein Harirchian
Position
Professor of neurology
Other areas of specialty/work
Street address
Iranian Center of Neurological Researches, Imam Khomeini Hospital, Blvd Keshavarz, Tehran, Iran
City
Tehran
Postal code
1419733141
Phone
+98 21161192424
Fax
Email
harirchm@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Bahaadin Siroos
Position
Resident of Neurology
Other areas of specialty/work
Street address
Iranian Center of Neurological Researches, Imam Khomeini Hospital, Blvd Keshavarz, Tehran, Iran. postcode 1419733141
City
Tehran
Postal code
1419733141
Phone
+98 21 6694 8899
Fax
Email
bsiroos@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)