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IRCT20161121031003N4 IRCT 2019-12-22 Iran University of Medical Sciences The effect of rivaroxaban and enoxaparin on the prophylaxis of venous thromboembolism 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. 2020-03-18 anticipated 150 Complete https://irct.ir/trial/38758 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, 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 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. 2-3 Knee or hip arthroplasty surgery. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: َAll data, including the primary and secondary outcomes, can be shared. When: 6 months after the publication of the results To whom: Our data will be available only to the researchers working in academic and scientific centers. Conditions: Our data will be available to the researchers working in academic and scientific centers. Where to obtain: Mostafa Salehpour provides the data analysis to the applicants via email: gharanizadeh.k@iums.ac.ir How to obtain: Applicants can be informed about the final results by sending an email to the given researcher and receiving a response within a week. Comments:
public Mostafa Salehpour
Shafa Yahyaian Hospital, Mojahedin Eslam Street
Tehran Iran (Islamic Republic of) 4816633131 +98 21 3354 2001 gharanizadeh.k@iums.ac.ir Iran University of Medical Sciences scientific Mostafa Salehpour
Shafa Yahyaian Hospital, Mojahedin Eslam Street
Tehran Iran (Islamic Republic of) 4816633131 +98 21 3354 2001 gharanizadeh.k@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) More than 18 years of age Who are candidate for hip or knee arthroplasty surgery 18 years no limit Both Severe side effects of a drug Moderate to severe hepatic disorder Cardiovascular diseases T84 Complications of internal orthopaedic prosthetic devices, implants and grafts Prevention Prevention 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. Deep vein thrombosis. Timepoint: 6, 12, and 24 weeks after the intervention. Method of measurement: Doppler ultrasound. The side effects of wounds. Timepoint: 6, 12, and 24 weeks after the intervention. Method of measurement: Questionnaire. Wound infection. Timepoint: 6, 12, and 24 weeks after the intervention. Method of measurement: Questionnaire. Gastrointestinal complications. Timepoint: 6, 12, and 24 weeks after the intervention. Method of measurement: Questionnaire. Skin complications. Timepoint: 6, 12, and 24 weeks after the intervention. Method of measurement: Questionnaire. Severe bleeding. Timepoint: 6, 12, and 24 weeks after the intervention. Method of measurement: Questionnaire. Iran University of Medical Sciences Approved 2016-07-31 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Shahid Hemmat Highway Tehran Tehran Iran (Islamic Republic of)