The objective of this clinical trial is evaluation of the effect of rTPA (recombinant tissue Plasminogen Activator) in clinical manifestations and prognosis of patients with ischemic stroke
Design
In this study, all patients with ischemic stroke will be assigned into the study.
Settings and conduct
The National Institutes of Health Stroke Scale (NIHSS) will be used to evaluate the clinical manifestations of ischemic stroke. The patients will be followed up for 3 months. 0.9 mg/Kg intravenous rTPA will be administered for single dose. Before the intervention, the NIHSS questionnaire will be recorded then one day, three days, seven days and one month, two months, and three months after the intervention will be followed up respectively.
Participants/Inclusion and exclusion criteria
Inclusion criteria of the study is Ischemic stroke patients; Referring to the hospital less than 4.5 hours and Indication of rtPA injection. Exclusion criteria of the study is intracerebral hemorrhage (ICH); Subarachnoid hemorrhage (SAH); subdural hematoma (SDH); contraindications for rTPA; venous sinus thrombosis.
Intervention groups
0.9 mg/Kg intravenous rTPA will be administered for single dose.
Main outcome variables
The National Institutes of Health Stroke Scale (NIHSS) will be used to evaluate the clinical manifestations of ischemic stroke. Before the intervention, the NIHSS questionnaire will be recorded then one day, three days, seven days and one month, two months, and three months after the intervention will be followed up respectively.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160318027097N10
Registration date:2018-06-01, 1397/03/11
Registration timing:registered_while_recruiting
Last update:2018-06-01, 1397/03/11
Update count:0
Registration date
2018-06-01, 1397/03/11
Registrant information
Name
ِDr Faramarz Darghahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3351 2000
Email address
mj.naghizadeh@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of effect of rTPA (recombinant tissue Plasminogen Activator) in clinical manifestations and prognosis of patients with ischemic stroke
Public title
Effect of rTPA (recombinant tissue Plasminogen Activator) in patients with ischemic stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with ischemic stroke
Referring to the hospital less than 4.5 hours
Indication of rtPA injection
with no evidence of hemorrhage on theinitial brain image
Exclusion criteria:
Age
From 18 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ardebil University of Medical Sciences
Street address
Ardabil University of Medical Sciences, Daneshgah Avenue, Ardabil, Iran
City
Ardebil
Province
Ardabil
Postal code
5163639888
Approval date
2017-08-13, 1396/05/22
Ethics committee reference number
IR.ARUMS.REC.1396.88
Health conditions studied
1
Description of health condition studied
Cerebellar stroke
ICD-10 code
G46.4
ICD-10 code description
Cerebellar stroke syndrome
Primary outcomes
1
Description
The stroke clinical manifestations
Timepoint
Befor the intervention, 24 hours, 48 hours, 168 hours, 1 month, 2 months, 3 months after the intervention