Objectives: To assess the effect treatment with tissue plasminogen activator in improving clinical status of patients with acute ischemic stroke.
Design: A randomized clinical trial.
Setting and conduct: The eligible patients with acute ischemic stroke who will refer to … Hospital during the study period will be enrolled into the trial.
Inclusion criteria: Age of 18 to 85 years; acute ischemic stroke.
Exclusion criteria: A history of acute ischemic stroke in the past 3 months; using heparin or warfarin in the past 48 hours; a history of head trauma in the past 3 months; a history of intra cranial hemorrhage; a history of myocardial infarction in the past 3 months; gastric hemorrhage in the past 3 months; a history of major surgery in the past 2 weeks; a history of convulsion.
Intervention group: Routine treatment plus tissue plasminogen activator 0.9 mg/kg through intravenous infusion.
Control group: Just routine treatment.
Primary outcome: Assessing the neurological signs every 12 hours for 72 hours using NIHSS scale.
Randomization: Random assignment of the patients to the intervention and control groups through drawing of lots.
Blinding: Not possible.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201709049014N182
Registration date:2017-09-09, 1396/06/18
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-09-09, 1396/06/18
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2017-12-21, 1396/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of treatment with tissue plasminogen activator in improving clinical status of patients with acute ischemic stroke: a randomized clinical trial
Public title
Effect of treatment with tissue plasminogen activator in improving clinical status of patients with acute ischemic stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age of 18 to 85 years; acute ischemic stroke.
Exclusion criteria: A history of acute ischemic stroke in the past 3 months; using heparin or warfarin in the past 48 hours; a history of head trauma in the past 3 months; a history of intra cranial hemorrhage; a history of myocardial infarction in the past 3 months; gastric hemorrhage in the past 3 months; a history of major surgery in the past 2 weeks; a history of convulsion.
Age
From 18 years old to 85 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: Random assignment of the patients to the intervention and control groups through drawing of lots.
Blinding: Not possible.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Approval date
2017-09-02, 1396/06/11
Ethics committee reference number
IR.UMSHA.REC.1396.408
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
Assessing the neurological signs
Timepoint
every 12 hours for 72 hours
Method of measurement
using NIHSS scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine treatment plus tissue plasminogen activator 0.9 mg/kg through intravenous infusion.
Category
Treatment - Drugs
2
Description
Control group: Just routine treatment.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Ali Ghadimi Farah
Street address
Sina Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
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 and Technology, Hamadan 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
Sina Hospital
Full name of responsible person
Ali Ghadimi Farah
Position
Medical Student
Other areas of specialty/work
Street address
Sina Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Postal code
Phone
+98 81 3827 4184
Fax
Email
aghf@ymail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sina Hospital
Full name of responsible person
Dr Mojtaba Khazaei
Position
Neurologist
Other areas of specialty/work
Street address
Sina Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Postal code
Phone
+98 81 3827 4184
Fax
Email
khazaeimajtaba@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)