Cerebral venous thrombosis is a disorder that can affect all age groups. In this study; we are going to compare the efficacy of low molecular weight heparin (1mg/kg twice a daily) versus unfractionated heparin (25000-65000 u/day) in cerebral venous thrombosis (CVT) treatment. In this clinical trial 36 patients with CVT diagnosed who referred to neurology clinic of Emam Reza hospital of kermanshah, will be randomly allocated into one of the two mentioned groups. In all patients, measure of global disability according to modified Rankin scale and NIH stroke scale will be assessed before of the treatment, discharge time, and one month later. Finally, measure of global disability, amount of admission times and mortality rate in each group will be compared.
General information
Acronym
CVST
IRCT registration information
IRCT registration number:IRCT201102241856N3
Registration date:2014-05-04, 1393/02/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-05-04, 1393/02/14
Registrant information
Name
Dariush Afshari
Name of organization / entity
Kermanshah University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 83 1835 0177
Email address
dafshari@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
kermanshah university of medical sciences and health servises.
Expected recruitment start date
2013-12-17, 1392/09/26
Expected recruitment end date
2014-09-28, 1393/07/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Treatment of cerebral venouse sinus thrombosis
Public title
Comparison of low mulecular weight heparin and unfractionated heparin in cerebral venouse thrombosis treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: the patients with cerebral venouse thrombosis diagnosed on the basis of MR venography. Exclusion criteria: age of <18 years old; contraindications for anticoagulant; bleeding disorder; hepatic or renal dysfunction; uncontrolled hypertension; thrombocytopenia; gastrointestinal hemorrhage; papilledema with impaired vision that required lumbar punctures.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences
Street address
Kermanshah University of Medical Sciences, Shahid Beheshti boulvered, Kermanshah
City
kermanshah
Postal code
Approval date
2013-12-17, 1392/09/26
Ethics committee reference number
پ/41099/420/7
Health conditions studied
1
Description of health condition studied
cerebral venouse sinus thrombosis
ICD-10 code
G46.8
ICD-10 code description
Other vascular syndromes of brain in cerebrovascular diseases
Primary outcomes
1
Description
measure of global disability
Timepoint
before of the trearment,discharge time,one month after discharge
Method of measurement
according to modified Rankin scale
Secondary outcomes
1
Description
focal neurologic deficit
Timepoint
before of treatment,discharge time,one month after discharge
Method of measurement
NIH Stroke scale
Intervention groups
1
Description
low molecular weight heparin 1mg/kg S/C twice a day for 7days.
Category
Treatment - Drugs
2
Description
unfractionated heparin 25000-65000 u IV daily for 7days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital of Kermanshah
Full name of responsible person
Dr. Dariush Afshari
Street address
Sorkhelijeh, Kermanshah
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Mr. Shirzadian
Street address
Kermanshah University of Medical Sciences, building no.2, Shahid Beheshti boulvered, Kermanshah
City
Kermanshah
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, Kermanshah University of Medical Sciences