The results of this study can be used to select the drug with the highest efficacy and the least complications to prevent postoperative coagulation disorders and to apply in national guidelines.
Design
Clinical trial with pragmatic control group, without blindness and randomization
Settings and conduct
Patients who are candidates for knee replacement surgery at Besat hospital of Hamadan
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with definite diagnosis of osteoarthritis, rheumatoid arthritis, or knee joint destruction by knee specialist who are candidates for knee replacement surgery due to pain and severe motor limitation.
Non-inclusion criteria for patients who have a history of allergic skin, respiratory or allergic to aspirin; have history of the anticoagulant drugs and hemorrhagic diseases, and have a history of malignancy and liver and kidney disease.
Intervention groups
Patients with definite diagnosis of osteoarthritis, rheumatoid arthritis or destruction of the articular surface
Main outcome variables
Deep Vein Thrombosis; Pulmonary Thromboembolism; Bleeding
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181128041784N1
Registration date:2019-03-05, 1397/12/14
Registration timing:registered_while_recruiting
Last update:2019-03-05, 1397/12/14
Update count:0
Registration date
2019-03-05, 1397/12/14
Registrant information
Name
Esmaeil Sadeghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3423 3331
Email address
esmailsadeghi93@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-23, 1397/10/02
Expected recruitment end date
2019-04-20, 1398/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison study on Effectiveness of Aspirin 80, Aspirin 325, Enoxaparin and Rivoroxaban in Prevention of Coagulopathy after Total Knee Arthroplasty
Public title
Effectiveness of Aspirin 80, Aspirin 325, Enoxaparin and Rivoroxaban in Prevention of Coagulopathy after Total Knee Arthroplasty
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with definite diagnosis of osteoarthritis, rheumatoid arthritis or joint destruction
Patients are candidates for knee replacement because of pain and severe motor limitation
Exclusion criteria:
History of skin allergy, respiratory or allergic to aspirin
History of the use of anticoagulant and hemorrhagic diseases
History of malignancy
History of liver and kidney disease
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
124
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly divided into four groups. Blind randomization method is used to assign patients to 4 groups. The block size is 8 according to the number of groups.
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 Hamadan University of Medical Sciences
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not 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
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
A portion of the data can be shared
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Researchers working in academics centers
Under which criteria data/document could be used
People who have the same study with us
From where data/document is obtainable
contact with correspond
What processes are involved for a request to access data/document
First, send an application by email or other communication channels to the author, then submit the application to the University of Science and Technology Vice-Chancellor for Research and Technology.