Objectives: To comparison of enoxaparine and Aspirin effects on mobility problems among non-hemorrhagic stroke patients.
Design: Randomized controlled clinical trial
Setting and conduct: 60 non-hemorrhagic stroke patients in Kashani Hospital in Shahrekord randomly assigned into two groups: experiment and control groups.
Participants:Inclusion criteria were stroke patients, with confirmed nonhemorrhagic stroke diagnosed by computed tomography scan (CT- scan) or magnetic resonance imaging (MRI), in Kashani Hospital in Shahrekord. And exclusion criteria were Patients with hemorrhagic ischemic stroke; trauma; secondary neurologic complications; metabolic disorders (hypokalemia; hyponatremia …).
Intervention: Experiment group were intradermally received 5000 units heparin every 6 hours or 4000-8000 units enoxaparine every day for 3 days; however, control group were received only 100-325 mg aspirin.
Main outcome measures: Muscular power, deep veins thrombosis and lung emboli.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201109067495N1
Registration date:2011-12-10, 1390/09/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-12-10, 1390/09/19
Registrant information
Name
Masoud Amiri
Name of organization / entity
Shahrekord University of MEdical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1333 3710
Email address
masoud.amiri@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Shahrekord Univrsity of Medical Sciences
Expected recruitment start date
2009-03-21, 1388/01/01
Expected recruitment end date
2010-03-20, 1388/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial on Enoxaparine and Aspirin effects on mobility problems of non-hemorrhagic stroke patients
Public title
Clinical trial on enoxaparine and Aspirin effects on mobility problems of stroke patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Stroke patients, with confirmed nonhemorrhagic stroke diagnosed by computed tomography scan (CT- scan) or magnetic resonance imaging (MRI), in Kashani Hospital in Shahrekord. ;
Exclusion criteria: Patients with hemorrhagic ischemic stroke; trauma; secondary neurologic complications; metabolic disorders (hypokalemia; hyponatremia …)
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahrekord University of Medical Sciences
Street address
Ethics Committee, Shahrekord University of Medical Sciences, Kashani Street
City
Shahrekord
Postal code
88155-383
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
Thesis number 831
Health conditions studied
1
Description of health condition studied
Non-hemorrhagic stroke
ICD-10 code
I63
ICD-10 code description
Cerebral Infarction
Primary outcomes
1
Description
Baseline muscular powers of patients
Timepoint
At the beginning of study
Method of measurement
Prothrombin time (PT) and partial thromboplastin time (PTT)
Secondary outcomes
1
Description
Muscular power of Limbs
Timepoint
َafter 3 days
Method of measurement
Prothrombin time and Tromboplastin time
Intervention groups
1
Description
60 non-hemorrhagic stroke patients were randomly assigned into two groups: Experiment and control groups. While experiment group were intradermally received 5000 units heparin every 6 hours or 4000-8000 units enoxaparine every day for 3 days.
Category
Treatment - Drugs
2
Description
60 non-hemorrhagic stroke patients were randomly assigned into two groups: Control group were received only 100-325 mg aspirin.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emergency Unit of Kashani Hospital
Full name of responsible person
Dr. Masoud Amiri
Street address
Department of Epidemiology and Biostatistics, Shahrekord University of Medical Sciences
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Shahrekord Univrsity of Medical Sciences
Full name of responsible person
Dr. Mahmoud Mobasheri
Street address
Vice Chancellor for Research, Shahrekord Medical University, Kashani Street
City
Shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Shahrekord Univrsity 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
Shahrekord University of Medical Sciences
Full name of responsible person
Dr. Masoud Amiri
Position
Assistant Professor in Epidemiology
Other areas of specialty/work
Street address
Dep. of Epidemiology and Biostatistics, School of Health, Rahmatieh
City
Shahrekord
Postal code
88155-383
Phone
+98 38 1333 3710
Fax
+98 38 1333 4678
Email
masoud.amiri@yahoo.com ; m.amiri@skums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Dr. Masoud Amiri
Position
Assistant Professor in Epidemiology
Other areas of specialty/work
Street address
Dep. of Epidemiology and Biostatistics, School of Health, Rahmatieh
City
Shahrekord
Postal code
88155-383
Phone
+98 38 1333 3710
Fax
+98 38 1333 4678
Email
masoud.amiri@yahoo.com ; m.amiri@skums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Dr. Masoud Amiri
Position
Assistant Professor in Epidemiology
Other areas of specialty/work
Street address
ِDep. of Epidemiology and Biostatistics, School of Health, Rahmatieh
City
Shahrekord
Postal code
88155-383
Phone
+98 38 1333 3710
Fax
+98 38 1333 4678
Email
masoud.amiri@yahoo.com ; m.amiri@skums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)