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IRCT20200808048333N1 IRCT 2021-10-29 Shahid Beheshti University of Medical Sciences Comparison of Rivaroxaban and Enoxaparin for preventing venous thromboembolism after spine surgery Evaluation of the effect of Rivaroxaban and Enoxaparin on preventing the venous thromboembolism after spinal surgery 2020-08-22 anticipated 200 Complete https://irct.ir/trial/53031 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: the block randomization method will be used, and 11 blocks of 10 people will be created. Sealed Envelope online software will be used to create random codes. The number of patients in groups A and B in each block is equal, but the random sequence will differ, Blinding description: All Participants, Investigators, Outcome assessors, Data analyst, and quality controller are blinded. Due to the difference in the form of administration, the double dummy technique was used for blinding, as patients in the enoxaparin group received the injectable form of enoxaparin and placebo tablets, and the patients in the rivaroxaban group received the injectable form of placebo and rivaroxaban tablets.Placebo forms (both tablets and injectable forms) have the same shape, color and packaging as the original drug form. 3 Deep Venous Thrombosis And Pulmonary Eembolism. Intervention 1: Intervention group: Recipient of Rivaroxaban, patients that receive Rivaroxaban (10mg orally) once daily after surgery to prevent venous thromboembolism, until discharged from hospital.In this group, the effects of this drug on thromboembolic events after surgery will be investigated. Intervention 2: Intervention group: Recipient of Enoxaparin, patients that recieve Enoxaparin (40 mg subcutaneous ) once daily after surgery to prevent venous thromboembolism, until discharged from hospital.In this group, the effects of this drug on thromboembolic events after surgery will be investigated. Intervention 3: Control group: no medication. Yes - There is a plan to make this available What will be shared: All data can be shared. When: Access period starts 6 months after the publication of the study To whom: Researchers working in academic and scientific institutions Conditions: For scientific and academic studies Where to obtain: Contact with Shahid beheshti university of medical sciences(info@sbmu.ac.ir) and Dr.hamidreza khayat kashani (hamidkhayat@yahoo.com). How to obtain: After approval from the University Vice Chancellor for Research, it is possible to share data. Comments:
public Hamidreza Khayat Kashani
Imam hosein hospital, Madani Ave, Nezamabad
Tehran Iran (Islamic Republic of) 1617763141 0098217343000 hamidkhayat@yahoo.com Shahid Beheshti University of Medical Sciences scientific Hamidreza Khayat Kashani
Imam hosein hospital, Madani Ave, Nezamabad
Tehran Iran (Islamic Republic of) 1617763141 0098217343000 hamidkhayat@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients undergoing spine surgery No previous history of thromboembolism 18 years no limit Both Previous history of venous thromboembolism Pregnancy History of cerebrovascular accident I82.4 Acute embolism and thrombosis of deep veins of lower extremity Treatment - Drugs Treatment - Drugs N/A Intervention group: Recipient of Rivaroxaban, patients that receive Rivaroxaban (10mg orally) once daily after surgery to prevent venous thromboembolism, until discharged from hospital.In this group, the effects of this drug on thromboembolic events after surgery will be investigated. Intervention group: Recipient of Enoxaparin, patients that recieve Enoxaparin (40 mg subcutaneous ) once daily after surgery to prevent venous thromboembolism, until discharged from hospital.In this group, the effects of this drug on thromboembolic events after surgery will be investigated. Control group: no medication Deep Vein Thrombosis. Timepoint: At the begining of the study,14 days after. Method of measurement: Color Doppler Ultrasonography of the lower Extremities. Shahid Beheshti University of Medical Sciences Approved 2020-11-10 Ethics committee of Shahid Beheshti University of Medical Sciences Shahid Beheshti University of Medical Sciences, Kudakyar street, Shahid Shahriari Square, Daneshjou Boulevard, Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)