Comparison of the efficacy of enoxaparin and aspirin in the prevention of deep venous thrombosis in patients undergoing orthostatic surgery for the reconstruction of anterior cruciate ligament
Comparison of the efficacy of enoxaparin and aspirin in the prevention of deep venous thrombosis in patients undergoing orthostatic surgery for the reconstruction of anterior cruciate ligament
Design
Clinical trials were randomized, double blind, with parallel groups and a sample size of 120 patients
Settings and conduct
120 patients will be randomly assigned to either the aspirin or the enoxaparin group according to the criteria for entering and leaving the study. In the enoxaparin group, treatment with enoxaparin 40 mg daily and subcutaneously for 10 days and the aspirin group will receive aspirin 325 mg twice daily for 20 days. Researchers, and the person analyzing the data are not aware of the type of drug received and the grouping.
Participants/Inclusion and exclusion criteria
Entry conditions:
Candidate for surgical reconstruction of anterior cruciate ligament
Age between 19 and 55
Non-entry condition:
Weight above 100 kg
Intervention groups
120 patients will be randomly assigned to either the aspirin or the enoxaparin group according to the criteria for entering and leaving the study. In the enoxaparin group, treatment with enoxaparin 40 mg daily and subcutaneously for 10 days and the aspirin group will receive aspirin 325 mg twice daily for 20 days.
Main outcome variables
Deep vein thrombosis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190325043107N7
Registration date:2019-07-27, 1398/05/05
Registration timing:registered_while_recruiting
Last update:2019-07-27, 1398/05/05
Update count:0
Registration date
2019-07-27, 1398/05/05
Registrant information
Name
Mehdi Khanbabayi Gol
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 7054
Email address
khanbabayimehdi69@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-01, 1398/04/10
Expected recruitment end date
2019-08-01, 1398/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of enoxaparin and aspirin in the prevention of deep venous thrombosis in patients undergoing orthostatic surgery for the reconstruction of anterior cruciate ligament
Public title
Prevention of DVT in ACL
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for surgical reconstruction of anterior cruciate ligament
Age from 19 to 55 years
Exclusion criteria:
Weight greater than 100 kg
Age
From 19 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, patients will be placed on a random number table and each person will be given a number from zero to 120. Coupled numbers will be in the aspirin group and the individual numbers will be in the enoxaparin group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The list of patients will be given to the caregiver and the caregiver will implement the type of intervention. The results of each person will only be recorded by the carer, and the data analyzer and the investigator will be unaware of the type of intervention received for each patient.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Approval date
2019-06-17, 1398/03/27
Ethics committee reference number
IR.TBZMED.REC.1398.307
Health conditions studied
1
Description of health condition studied
Deep vein thrombosis
ICD-10 code
I80.2
ICD-10 code description
Phlebitis and thrombophlebitis of other and unspecified deep vessels of lower extremities
Primary outcomes
1
Description
Deep vein thrombosis
Timepoint
Daily
Method of measurement
Sonography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Treatment with enoxaparin with a dose of 40 mg will be given daily and subcutaneously for 10 days.
Category
Prevention
2
Description
Control group: Treatment with aspirin 325 mg twice daily for 20 days will be performed.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Amir Mohammad Navali
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
6165665631
Phone
+98 41 3335 5921
Email
Drvaez@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Phone
+98 41 3335 7310
Email
Ajouyban@hotmail.com
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
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
Tabriz University of Medical Sciences
Full name of responsible person
Fatemeh Mousavi Vaezi
Position
Resident of orthopedics
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764873
Phone
+98 41 3334 7054
Fax
Email
Drvaez@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fatemeh Mousavi Vaezi
Position
Resident of orthopedics
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Phone
+98 41 3335 7310
Email
Drvaez@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
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