Aim of this study is the effects of Filgrastimin on Complications of patients with cerebral hemorrhage due to head trauma. This study is clinical trial and double blind. 68 patients will be entered to the emergency room in Valiasr hospital in Arak with brain hemorrhage resulting from head trauma. We will check hemoglobin and hematocrit and Platelets and Electrolytes before and in and after treatment. We will inject 150 microgram Filgrastimin subcutaneous in 4 day in intervention group (34 patients). We will inject normal saline in control group ( 34 patients). We follow up patients for embolism and deep vein thrombosis and paralyzed limb strength before and after treatment. We will record mortality and number of hospitalization days after treatment. Inclusion criteria: 18 years and more; patients with cerebral hemorrhage due to head trauma; level of consciousness between 9 -13
Exclusion criteria: alcohol consumption and addiction; allergy for drug; history of hypertension and diabetes and embolism and deep vein thrombosis; patient died 72 hours after admission
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017020120258N30
Registration date:2017-02-14, 1395/11/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-14, 1395/11/26
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
Arak University of Medical Sciences
Expected recruitment start date
2016-06-14, 1395/03/25
Expected recruitment end date
2017-06-15, 1396/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of Filgrastimin on Complications of patients with cerebral hemorrhage due to head trauma
Public title
The effects of Filgrastimin on Complications of patients with cerebral hemorrhage due to head trauma
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 18 years and more; patients with cerebral hemorrhage due to head trauma; level of consciousness between 9 -13
Exclusion criteria: alcohol consumption and addiction; allergy for drug; history of hypertension and diabetes and embolism and deep vein thrombosis; patient died 72 hours after admission
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomize by table of random numbers
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Arak University Of Medical Sciences
Street address
Dr Mohammad Rafiei, Vice chancellor for research, Payambar azam complex, Basij squre, Sardasht, Arak
City
Arak
Postal code
38149578558
Approval date
2016-06-13, 1395/03/24
Ethics committee reference number
IR.ARAKMU.REC.1395.100
Health conditions studied
1
Description of health condition studied
cerebral hemorrhage due to head trauma
ICD-10 code
I61.1
ICD-10 code description
Intracerebral haemorrhage in hemisphere, cortical
Primary outcomes
1
Description
Blood pressure
Timepoint
Before and in and after treatment
Method of measurement
Barometer
2
Description
Hemoglobin
Timepoint
Before and in and after treatment
Method of measurement
Blood test
3
Description
Electrolytes
Timepoint
Before and in and after treatment
Method of measurement
Blood test
4
Description
Hematocrit
Timepoint
Before and in and after treatment
Method of measurement
Blood test
5
Description
Paralyzed limb strength
Timepoint
before and after treatment
Method of measurement
Physical examination
6
Description
deep vein thrombosis
Timepoint
before and after treatment
Method of measurement
CT venography
7
Description
number of hospitalization days
Timepoint
After treatment
Method of measurement
Observation
8
Description
Mortality
Timepoint
After treatment
Method of measurement
Observation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: We will inject 150 micro gram Filgrastimin subcutaneous in 4 day in intervention group (34 patients).
Category
Treatment - Drugs
2
Description
Control group: We will inject normal saline in control group ( 34 patients).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Dr Arash Yazdanbakhsh
Street address
Valiasr Hospital, Arak
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Arak University of Medical Sciences