Protocol summary

Summary
The objective of this study was to compare deep vein thrombosis prophylactic procedures in patients with cerebrovascular accident. A total of 100 patients with CVA and hemiparesis, admitted in neurology ward of Golestan Hospital of Ahvaz, were enrolled in the study and assigned into subgroups (50 patients in each group). The patients in the intervention group received heparin, 5000 unit, subcutaneously, twice daily but in the control group received compressive stocking for DVT prevention over the entire course of admission. The incidence of DVT was evaluated and compared between two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201010144939N1
Registration date: 2010-11-07, 1389/08/16
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-11-07, 1389/08/16
Registrant information
Name
Asal faraji
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1391 2943
Email address
faraji@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Jundishapur University of Medical Sciences
Expected recruitment start date
2009-05-14, 1388/02/24
Expected recruitment end date
2010-09-21, 1389/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of heparin and compressive stocking in deep vein thrombosis prophylaxy in cerebrovascular patients admitted in Golestan hospital
Public title
The comparison of deep vein thrombosis prophylactic procedures in patients with cerebrovascular accident
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: admitted patients with cerebrovascular accident (CVA), presence of hemiparesis Exclusion criteria: need for anticoagulant therapy (warfarin) over the admission course
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
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
Ahvaz Jundishapur University of Medical Sciences
Street address
Jundishapur University, Golestan, Ahvaz
City
Ahvaz
Postal code
Approval date
2010-09-10, 1389/06/19
Ethics committee reference number
پ/8/20//4105

Health conditions studied

1

Description of health condition studied
Cerebrovascular Accident
ICD-10 code
I64
ICD-10 code description
Stroke not specified as haemorrhage or infarction

Primary outcomes

1

Description
Hemiparesis
Timepoint
Admission Course
Method of measurement
Clinical Signs (force muscle)

Secondary outcomes

1

Description
Deep Vein Thrombosis
Timepoint
Over Admission Course
Method of measurement
Clinical Signs (edema, warmness, tenderness, Hoffman's sign, size difference)

Intervention groups

1

Description
Heparin 5000 unit/ sc/BD over admission course
Category
Prevention

2

Description
compressive stocking over admission course
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Neurology Ward, Golestan Hospital
Full name of responsible person
Asal Faraji
Street address
Golestan Hospital, Ahvaz
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Deputy of Ahvaz Jundishapur University
Full name of responsible person
Dr. Nastaran Madjdinasab
Street address
School of Medicine, Jundishapur University, Golestan, Ahvaz
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Ahvaz Jundishapur University
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
Ahvaz Jundishapur University of Medical Science
Full name of responsible person
Asal Faraji
Position
Neurology Resident
Other areas of specialty/work
Street address
Ahvaz-Golestan-School of Medicine, Jundishapur University of Medical Sciences, Golestan, Ahvaz
City
Ahvaz
Postal code
Phone
+98 912 699 8890
Fax
Email
faraji@ajums.ac.irasal1291@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Nastaran Majdinasab
Position
Assistant Professor
Other areas of specialty/work
Street address
School of Medicine, Jundishapur University of Medical Sciences, Golestan, Ahvaz
City
Ahvaz
Postal code
Phone
+98 916 311 6496
Fax
Email
N.madjdinasab@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Asal Faraji
Position
Neurology Resident
Other areas of specialty/work
Street address
Golestan Hospital of Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 1391 2943
Fax
Email
faraji@ajums.ac.irasal1291@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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