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Comparison the Effect of Aspirin and Enoxaparin on the prevention of deep venous thrombosis in patients with ankle sprain with immobilization of lower extremities in the form of short plaster

Protocol summary

Study aim
Comparison the Effect of Aspirin and Enoxaparin on the prevention of deep venous thrombosis in patients with ankle sprain with immobilization of lower extremities in the form of short plaster
Design
In this research, 195 eligible patients referring to Imam Khomeini Hospital of sari suffering from Ankle sprain were chosen purposefully and were divided into three groups of control and intervention one and two.
Settings and conduct
This study was conducted at Imam Khomeini Hospital and among patients who entered the study according to inclusion criteria. Then, patients will be divided into three groups . the first group (control group), the drug will not be prescribed (the current method in orthopedic and emergency clinics). For the second group, aspirin tablets will be given at a dose of 325 mg daily for 3 weeks. For the third group Enoxaparin; Brand name ClEXANE, 40 mg daily, injected subcutaneously for 3 weeks. Patients will be aware of signs and symptoms of venous thrombosis at the beginning of treatment and will be followed up by the end of the treatment by telephone or in person. After 3 weeks, plaster will be opened and patients will be referred to the laboratory for measuring d-dimer. The lab will not be aware of the patient's therapeutic treatment. Patients with d-dimer levels above 0.2 milligrams per liter will be referred to a collaborator's sonography specialist to investigate the presence of deep vein thrombosis in order to confirm the presence or absence of deep vein thrombosis through Doppler ultrasonography. The sonography specialist is not aware of patient’s group of treatment and how much the d-dimer level is. Patients will be examined for the presence of deep vein thrombosis
Participants/Inclusion and exclusion criteria
major inclusin and exclusion criteria: Patients Aged equal or over 50 years, with ankle sprain Grade 2,3 were included; Patients who have Ankle instability, Ankle medial injury, syndesmosis damage, Wound on the site of injury, The presence of other fractures, People who have an anticoagulant use history were excluded.
Intervention groups
Intervention group one: Aspirin tablet with dose of 325 mg per day for 3 weeks Intervention group two: Enoxaparin, brand name Clexane, with a dose of 40 mg daily subcutaneous injection for 3 weeks Control group: No Drugs will be prescribed.
Main outcome variables
D-Dimer value in the D-Dimer test

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120726010405N5
Registration date: 2018-03-10, 1396/12/19
Registration timing: registered_while_recruiting

Last update: 2018-03-10, 1396/12/19
Update count: 0
Registration date
2018-03-10, 1396/12/19
Registrant information
Name
mehran razavipour
Name of organization / entity
mazandaran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1325 7230
Email address
m.razavipour@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the Effect of Aspirin and Enoxaparin on the prevention of deep venous thrombosis in patients with ankle sprain with immobilization of lower extremities in the form of short plaster
Public title
Comparison the Effect of Aspirin and Enoxaparin on the prevention of deep venous thrombosis in patients with ankle sprain with immobilization of lower extremities in the form of short plaster
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age greater than or equal to 15 years Ankle Sprain on the lateral side: Grade 2 and 3
Exclusion criteria:
Ankle instability Medial Ankle injury Syndesmosis damage Wound on the site of injury The presence of other fractures People who have an anticoagulant use history
Age
From 15 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 195
Randomization (investigator's opinion)
Not 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
Ethics Committee of Mazandaran University of Medical Science
Street address
Deputy of Research and Technology of Mazandaran University of Medical Sciences,Moalem Sq., Moalem St., Sari
City
Sari
Province
Mazandaran
Postal code
۳۳۹۷۱-۴۸۱۵۷
Approval date
2016-09-06, 1395/06/16
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.95.2536

Health conditions studied

1

Description of health condition studied
Sprain of ankle
ICD-10 code
S93.4
ICD-10 code description
Sprain of ankle

Primary outcomes

1

Description
D-Dimer value in the D-Dimer test
Timepoint
Measurement of D-Dimer Test at before intervention and 21 days after administration of Aspirin and ٍEnoxaparin
Method of measurement
D-Dimer Test kit

Secondary outcomes

empty

Intervention groups

1

Description
ّFirst Intervention group: Aspirin Tablets with dose of 325 mg/day for 3 weeks
Category
Treatment - Drugs

2

Description
Second Intervention group:Enoxaparin, brand name of Clexane, with a dose of 40 mg daily subcutaneous injection for 3 weeks
Category
Treatment - Drugs

3

Description
Control group: No drugs
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Doctor Mehran Razavi Pour
Street address
Imam Khomeini Hospital, Amir Mazandarani St., Sari
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3337 7169
Email
m.razavipour@mazums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Doctor Ahmad Ali Enayati
Street address
Deputy of Research and Technology of Mazandaran University of Medical Science, moalem Sq., Moalem St., Sari
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3337 7169
Email
m.razavipour@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr seyed Mehran Razavipour
Position
Hand Surgery
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Mazandaran University of Medical Sciences, First of Vali Asr HWY., Joibar Junction, Emam Sq., Sari
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3337 7169
Fax
Email
m.razavipour@mazums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr seyed Mehran Razavipour
Position
Hand Surgery
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Mazandaran University of Medical Sciences, First of Vali Asr HWY., Joibar Junction, Emam Sq., Sari
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3337 7169
Fax
Email
m.razavipour@mazums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Doctor Mehdi Mohebbi
Position
Orthopedic resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Mazandaran University of Medical Sciences, First of Vali Asr HWY., Joibar Junction, Emam Sq., Sari
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3337 7169
Fax
Email
m.razavipour@mazums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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