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The Effects of Filgrastim on Prognosis of Patients with acute Ischemic Stroke

Protocol summary

Study aim
The Effects of Filgrastim on Prognosis of Patients with acute Ischemic Stroke
Design
Aim of this study is evaluation Filgrastim on Prognosis of Patients with acute Ischemic Stroke.This study is clinical trial and double blind.84 patients enter referring to emergency department of Valiasr Hospital in Arak with stroke symptoms.
Settings and conduct
This study is clinical trial and double blind.84 patients enter referring to emergency department of Valiasr Hospital in Arak with stroke symptoms.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 18 years and more; Patients with acute ischemic stroke Exclusion criteria: Drinking alcohol and addict; Incidence of side effects or the sensitivity of the drug; history of blood pressure, diabetes, embolism and DVT; death of the patient 72 hours after entering the emergency room
Intervention groups
We treat patients(42 person) by 150 milligram in 24 hours Filgrastim in 3 days in intervention group.We treat patients(42 person) 150 milligram in 24 hours normal salin in control group.
Main outcome variables
Effects of Filgrastim on prognosis clinical (power paralysis, condition of consciousness, motor status) of patients with acute Ischemic Stroke

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20141209020258N63
Registration date: 2018-01-22, 1396/11/02
Registration timing: registered_while_recruiting

Last update: 2018-01-22, 1396/11/02
Update count: 0
Registration date
2018-01-22, 1396/11/02
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-06-19, 1395/03/30
Expected recruitment end date
2018-06-20, 1397/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effects of Filgrastim on Prognosis of Patients with acute Ischemic Stroke
Public title
The Effects of Filgrastim on Prognosis of Patients with acute Ischemic Stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18 years and more Patients with acute ischemic stroke
Exclusion criteria:
Drinking alcohol and addict Incidence of side effects or the sensitivity of the drug History of blood pressure, diabetes, embolism and DVT Death of the patient 72 hours after entering the emergency room
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 84
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization with random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient is not aware of the treatment received.Participant and Analyzer are blind (double blind).
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee Arak University Of Medical Sciences
Street address
Vice chancellor for research, Payambar azam complex, Basij squre, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3814957558
Approval date
2016-06-13, 1395/03/24
Ethics committee reference number
IR.ARAK.MU.REC.1395.101

Health conditions studied

1

Description of health condition studied
acute Ischemic Stroke
ICD-10 code
I63.9
ICD-10 code description
Cerebral infarction, unspecified

Primary outcomes

1

Description
Hemoglobin
Timepoint
Before and during treatment and 4 weeks after treatment
Method of measurement
blood test

2

Description
power of the paraplegic organ
Timepoint
Before and during treatment and 4 weeks after treatment
Method of measurement
Physical examination

3

Description
Awareness status
Timepoint
Before and during treatment and 4 weeks after treatment
Method of measurement
Glasgow Coma Scale

4

Description
Motion status
Timepoint
Before and during treatment and 4 weeks after treatment
Method of measurement
Physical examination

5

Description
Hematocrit
Timepoint
Before and during treatment and 4 weeks after treatment
Method of measurement
blood test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: We treat patients(42 person) by 150 milligram in 24 hours Filgrastim in 3 ‎days in intervention group.
Category
Treatment - Drugs

2

Description
Control group: We treat patients(42 person) 150 milligram in 24 hours normal salin in control ‎group.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Dr Morteza Gharibi
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
mgharibi@arakmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Aliarash Anoshirvani
Street address
Vice chancellor for research, Payambar azam complex, Basij squre, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
38149578558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
anoshirvani@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Morteza Gharibi
Position
Assistant professor, emergency Medicine Specialist
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
gharibi@arakmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Mohsen Ebrahimimonfared
Position
Assistant professor,Neurologist
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
Ebrahimi@arakmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Leila Mirhosseini Ardakani
Position
resident of Emergency Medicine Specialist
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
mirhosseini@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
When we publish article in journal.
When the data will become available and for how long
After the article is published
To whom data/document is available
researcher in university
Under which criteria data/document could be used
If there are additional questions
From where data/document is obtainable
Dr Ebrahimi Monfared
What processes are involved for a request to access data/document
They have to write letters to the professors and the university.
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