Effects of Knee length graduated compression stockings versus thigh length graduated compression stockings in preventing deep vein thrombosis in patients with hemorrhagic stroke.
This study has been designed with aim to determine the effects of Knee length graduated compression stockings compared with thigh length graduated compression stockings for prevention of deep vein thrombosis in patients with hemorrhagic stroke.The study was a randomized, not blinded, non-controlled drugs. Population study is included all patients with hemorrhagic stroke, which will hospitalization at intensive care unit.The patients in demographic characteristics for the participate in the study will not be limited and hemorrhagic stroke them after go to the hospital and be diagnosed by a neurologist.Patients will be enrolled that at least exist hemiplegia in the one of the lower extremity. If the patient died during the study period and the lack of cooperation in the use of compression socks, will be excluded.According to the size of the study population on one year in the hospital, on based to a pilot study conducted, which is about 80 people as well as the frequency of deep vein thrombosis in patients, is estimated at nearly 40 cases in each group.The intervention in this study is the randomly use of Knee length graduated compression stockings and thigh length graduated compression stockings in patients with hemorrhagic stroke in the first 10 days diseases.
Finally, differences in the impact of Knee length graduated compression stockings and thigh length graduated compression stockings in the prevention of deep vein thrombosis in patients with hemorrhagic stroke will be discussed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013120815708N1
Registration date:2014-01-17, 1392/10/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-01-17, 1392/10/27
Registrant information
Name
Ehsan Azami
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 2991
Email address
eh.azami@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2014-01-01, 1392/10/11
Expected recruitment end date
2014-08-21, 1393/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Knee length graduated compression stockings versus thigh length graduated compression stockings in preventing deep vein thrombosis in patients with hemorrhagic stroke.
Public title
Comparison of Anti-thrombosis compression socks in prevention of deep vein thrombosis in patients with hemorrhagic stroke.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
-All patients with hemorrhagic stroke hospitalized at intensive care unit of the hospital Skryh.
- There is at least one lower limb hemiplegia patients.
- Lack of deep vein thrombosis in first Doppler ultrasound.
- Lack of coagulation disorders on admission tests(PT-PTT-INR).
- Lack of history of deep vein thrombosis according to patient's history.
Exclusion criteria:
- The patient died during the study period.
- Lack of patient cooperation for using compression socks.
- Failure to refer patient for further Doppler ultrasound on tenth day.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Kashan University of Medical Sciences
Street address
Kilometer 5, Ghotbe ravandi boulevard
City
kashan
Postal code
87155/111
Approval date
2014-01-01, 1392/10/11
Ethics committee reference number
4076/1/5/29/پ
Health conditions studied
1
Description of health condition studied
Intracerebral haemorrhage
ICD-10 code
I61.9
ICD-10 code description
Intracerebral haemorrhage, unspecified
Primary outcomes
1
Description
Deep vein thrombosis
Timepoint
The first and tenth day after the onset of hemorrhagic stroke
Method of measurement
Clinical signs - Doppler Ultrasound
Secondary outcomes
1
Description
The patient immobilization rate after hemorrhagic stroke
Timepoint
At the time of Admission
Method of measurement
Based on clinical examination and observation
Intervention groups
1
Description
Thigh Length Graduated Compression Stockings /used in ten days, the patient in this study
Category
Prevention
2
Description
Knee Length Graduated Compression Stockings /used in ten days, the patient in this study
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Askarie hospital
Full name of responsible person
Ehsan Azami
Street address
Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Gholam ali Hamidi
Street address
Isfahan/kashan / 5 km ghotbe Ravandi Boulevard/ Kashan University of Medical Sciences
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Ehsan Azami
Position
Graduate student of nursing intensive care
Other areas of specialty/work
Street address
Kashan, 5 km ghotbe Ravandi Boulevard
City
Kashan
Postal code
111/87155
Phone
+98 36 1555 0021
Fax
+98 36 1557 5057
Email
eh.azami66@yahoo.comeh.azami@kaums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Masoomeh Abedzadeh
Position
Postgraduate Midwifery
Other areas of specialty/work
Street address
Kashan, 5km ghotbe Ravandi Boulevard
City
Kashan
Postal code
111/87155
Phone
+98 36 1555 0021
Fax
+98 36 1555 6633
Email
abedzadeh@kaums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical sciences
Full name of responsible person
Ehsan Azami
Position
Graduate student of nursing intensive care
Other areas of specialty/work
Street address
Kashan, 5 km ghotbe Ravandi Boulevard
City
Kashan
Postal code
Phone
+98 36 1555 0021
Fax
Email
eh.azami66@yahoo.comeh.azami@kaums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)