A clinical trial to compare the effect of rivaroxaban with enoxaparin on the prophylaxis of venous thromboembolism in patients undergoing knee or hip arthroplasty surgery.
The comparison of the effect of rivaroxaban with enoxaparin on prophylaxis of venous thromboembolism in patients undergoing knee or hip arthroplasty surgery.
Design
In this double-blind clinical trial, 150 patients who were candidate for hip or knee arthroplasty surgery were assigned into parallel groups using the table of random numbers.
Settings and conduct
The patients are candidates for hip or knee arthroplasty surgery at Shafa Yahyaian Hospital, Tehran, Iran. In this double-blind study, the clinical care provider and data collector were blind regarding the group assignment and the type of treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The patients who are more than 18 years of age, and those who are candidate for hip or knee arthroplasty surgery.
Exclusion criteria: The patients with severe side effects of a drug, moderate to severe hepatic disorder, and cardiovascular diseases were excluded from the study.
Intervention groups
The intervention group I will receive 40 mg enoxaparin (Rolexan, Ronakdaru, Iran) subcutaneously on a daily basis for 14 days, followed by the administration of 325 mg aspirin daily for 14 days. The intervention group II will receive 10 mg rivaroxaban (Axabin, Iran Hormone, Iran) orally on a daily basis for 12 days, followed by the administration of 325 mg aspirin daily for 14 days.
Main outcome variables
Deep vein thrombosis; the side effects of wounds; wound infection; gastrointestinal complications; skin complications; severe bleeding.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161121031003N4
Registration date:2019-12-22, 1398/10/01
Registration timing:prospective
Last update:2019-12-22, 1398/10/01
Update count:0
Registration date
2019-12-22, 1398/10/01
Registrant information
Name
Kaveh Gharanizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3354 2000
Email address
gharanizadeh.k@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-18, 1398/12/28
Expected recruitment end date
2020-05-17, 1399/02/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to compare the effect of rivaroxaban with enoxaparin on the prophylaxis of venous thromboembolism in patients undergoing knee or hip arthroplasty surgery.
Public title
The effect of rivaroxaban and enoxaparin on the prophylaxis of venous thromboembolism
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
More than 18 years of age
Who are candidate for hip or knee arthroplasty surgery
Exclusion criteria:
Severe side effects of a drug
Moderate to severe hepatic disorder
Cardiovascular diseases
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
The subjects will be randomly assigned into two groups of 75 patients with blocks of 2 and 4 using randomization method. A noninvolved researcher will determine the random assignment sequencing in sample selection based on a statistical analysis system (SAS), computer software. Sequentially numbered sealed opaque envelopes will be used to conceal the sequencing. Accordingly, the participants were given codes and assigned into the intervention and control groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
The patients are candidates for hip or knee arthroplasty surgery at Shafa Yahyaian Hospital, in Tehran, Iran. In this single-blind study, the responsible individuals for data collection are unaware of the type of drug in the selection of participants.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2016-07-31, 1395/05/10
Ethics committee reference number
IR.IUMS.FMD.REC.1395.347
Health conditions studied
1
Description of health condition studied
Knee or hip arthroplasty surgery
ICD-10 code
T84
ICD-10 code description
Complications of internal orthopaedic prosthetic devices, implants and grafts
Primary outcomes
1
Description
Deep vein thrombosis
Timepoint
6, 12, and 24 weeks after the intervention
Method of measurement
Doppler ultrasound
Secondary outcomes
1
Description
The side effects of wounds
Timepoint
6, 12, and 24 weeks after the intervention
Method of measurement
Questionnaire
2
Description
Wound infection
Timepoint
6, 12, and 24 weeks after the intervention
Method of measurement
Questionnaire
3
Description
Gastrointestinal complications
Timepoint
6, 12, and 24 weeks after the intervention
Method of measurement
Questionnaire
4
Description
Skin complications
Timepoint
6, 12, and 24 weeks after the intervention
Method of measurement
Questionnaire
5
Description
Severe bleeding
Timepoint
6, 12, and 24 weeks after the intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
The intervention group I will receive 40 mg enoxaparin (Rolexan, Ronakdaru, Iran) subcutaneously on a daily basis for 14 days, followed by the administration of 325 mg aspirin daily for 14 days.
Category
Prevention
2
Description
The intervention group II will receive 10 mg rivaroxaban (Axabin, Iran Hormone, Iran) orally on a daily basis for 12 days, followed by the administration of 325 mg aspirin daily for 14 days.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Yahyaian Hospital
Full name of responsible person
Kaveh Gharanizadeh
Street address
Shafa Yahyaian Hospital, Mojahedin Eslam Street
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 3354 2005
Email
gharanizadeh.k@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seeyed Abbas Motevalian
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Fax
Email
PR@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Mostafa Salehpour
Position
Orthopedics
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Shafa Yahyaian Hospital, Mojahedin Eslam Street
City
Tehran
Province
Tehran
Postal code
4816633131
Phone
+98 21 3354 2001
Email
gharanizadeh.k@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mostafa Salehpour
Position
Orthopedics
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Shafa Yahyaian Hospital, Mojahedin Eslam Street
City
Tehran
Province
Tehran
Postal code
4816633131
Phone
+98 21 3354 2001
Email
gharanizadeh.k@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mostafa Salehpour
Position
Orthopedics
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Shafa Yahyaian Hospital, Mojahedin Eslam Street
City
Tehran
Province
Tehran
Postal code
4816633131
Phone
+98 21 3354 2001
Email
gharanizadeh.k@iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
َAll data, including the primary and secondary outcomes, can be shared.
When the data will become available and for how long
6 months after the publication of the results
To whom data/document is available
Our data will be available only to the researchers working in academic and scientific centers.
Under which criteria data/document could be used
Our data will be available to the researchers working in academic and scientific centers.
From where data/document is obtainable
Mostafa Salehpour provides the data analysis to the applicants via email: gharanizadeh.k@iums.ac.ir
What processes are involved for a request to access data/document
Applicants can be informed about the final results by sending an email to the given researcher and receiving a response within a week.