Prevention of deep vein thrombosis in spinal cord injury, mechanical prophylaxis with or with out pharmacological prophylaxies.A randomized controled trial.
The aim of this study is to compare the effects of mechanical prophylaxis with or without pharmacological prophylaxis on prevention of deep vein thrombosis in patients with spinal cord injury.
This study is a prospective double blind randomized clinical trial and all patients having the inclusion criteria for this study, randomly will set in three groups with 25 cases. We will use respectively for first group (Low Molecular Weight Heparin(Enoxaparin) 40mg daily plus compressive stocking ), for second group (Unfractionated Heparin 5000Unit /subcutaneous /two times daily and compressive stocking ) and for third group only compressive stocking. Starting to administration of prophylaxis for inpatients, from the first day of hospital stay after hemodynamic stabilizing and will continue until discharge. Inclusion criteria of our study patients are: 1) Patients with spinal cord injury 2)Absence of underlying problems 3)Absence of coagulopathy disorders 4) Renal failure 5) Fractures in other extremities 6) Patients having content to study. If any case who has fractures in other extremities and underlying problems, will exclude from the study.
Then we will compare the incidence rate of deep vein thrombosis in hospital
stay period between these groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014111119908N1
Registration date:2014-12-01, 1393/09/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-12-01, 1393/09/10
Registrant information
Name
Mohammad Amin Mohammad Zadeh Gharabaghi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 5921
Email address
aminakbar66@yahoo.com
Recruitment status
Recruitment complete
Funding source
Student Research Committee, Tabriz University Of Medical Sciences
Expected recruitment start date
2012-03-20, 1391/01/01
Expected recruitment end date
2014-12-22, 1393/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Prevention of deep vein thrombosis in spinal cord injury, mechanical prophylaxis with or with out pharmacological prophylaxies.A randomized controled trial.
Public title
Prevention of deep vein thrombosis in spinal cord injury, mechanical prophylaxis with or with out pharmacological prophylaxies.A randomized controled trial.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria of patients: Patients with spinal cord injury; Absence of coagulopathy disorders; Renal failure; Fractures in other extremities; Patients having consent to study
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
75
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
Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht Ave, Azadi Ave, Tabriz
City
Tabriz
Postal code
51665118
Approval date
2014-01-07, 1392/10/17
Ethics committee reference number
10210101912021
Health conditions studied
1
Description of health condition studied
spinal cord injury
ICD-10 code
T09.3
ICD-10 code description
Injury of spinal cord, level unspecified
Primary outcomes
1
Description
Formation of thrombosis in deep veins
Timepoint
Duration of hospital stay period
Method of measurement
Clinical examination and Doppler sonography
Secondary outcomes
empty
Intervention groups
1
Description
Low Molecular Weight Heparin 40mg daily plus compressive stocking
Category
Prevention
2
Description
Unreactionated Heparin 5000Unit /subcutaneous /two times daily with compressive stocking
Category
Treatment - Drugs
3
Description
compressive stocking
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Amin Mohammad Zadeh Gharabaghi
Street address
Tabriz University of Medical Sciences, Golghasht Ave, Azadi Ave, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr Ali Meshkini
Position
Professor Of Neuro Surgery
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Golghasht Ave, Azadi Ave, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3335 5921
Fax
Email
meshkinia@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of medical Sciences
Full name of responsible person
Dr Ali Meshkini
Position
Specialist in Neuro Surgery
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Golghasht Ave, Azadi Ave, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3335 5921
Fax
Email
meshkinia@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Mohammad Amin Mohammad Zadeh Gharabaghi
Position
Medical student
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
aminakbar66@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)