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IRCT20120527009878N16 IRCT 2023-07-22 Tabriz University of Medical Sciences Efficiency of rivaroxaban and enoxaparin in the prevention of venous thromboembolic events Comparison of efficiency and safety of rivaroxaban and subcutaneous enoxaparin in the prevention of venous thromboembolic events after spinal instrumentation surgery 2023-07-06 anticipated 60 Complete https://irct.ir/trial/70249 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, individuals were assigned to two groups using the permutation block method(without replacement). In this method, A represents the individual receiving the rivaroxaban and B represents the individual in the subcutaneous enoxaparin group. Considering the quadruple block; they were classified into AABB, ABAB, ABBA, BAAB BBAA, and BABA permutations, and by random selection from permutation, patients were classified, Blinding description: The randomization will be concealed using a sealed envelope prior to the start of the study, and the evaluator and the statistical analyst will be completely blind to the process. Upon arrival, individuals will be assigned to either the rivaroxaban or the subcutaneous enoxaparin group based on the letters A and B in their packet. the therapist, in the absence of evaluators, will provide the desired treatment based on the letter in the packet. In order to allocate concealment, the type of intervention will be written on paper and placed in matte, and packed envelopes. 2 Spinal fusion. Intervention 1: Intervention group: People who receive oral Rivaroxaban (Aboreihan Company) 10 mg twice a day after surgery for one week. Intervention 2: Control group: people who receive subcutaneous Enoxaparin (Tehran Chemical Company) 40 mg daily for one week after surgery. Yes - There is a plan to make this available What will be shared: A portion of the data that represents the final outcome When: The access period starts 6 months after the results are published. To whom: The data of this study will be available only to researchers working in academic and scientific institutions. Conditions: For modeling and guidance Where to obtain: The person responsible for updating study information How to obtain: The applicant provides information about their application via email. Up to two weeks after the request, if accepted, documents or data files will be sent. Comments:
public Dr.Farhad Mirzaei
Neurosurgery ward, Emam Reza Hospital, Gholghasht Street, Azadi Street
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3334 0830 golzar.farhad@yahoo.com Tabriz University of Medical Sciences scientific Dr Ali Meshkini
Neurosurgery ward, Emam Reza Hospital, Gholghasht Street, Azadi Street,
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 1334 0830 meshkinia@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Patients who have undergone spine surgery and have no previous history of venous thromboembolism . 20 years 60 years Both Patient dissatisfactionsm patients with coagulation disorders People with underlying diseases such as high blood pressure, diabetes and severe osteoporosis Patients with kidney failure M99.3 Osseous stenosis of neural canal Treatment - Drugs Treatment - Drugs Intervention group: People who receive oral Rivaroxaban (Aboreihan Company) 10 mg twice a day after surgery for one week. Control group: people who receive subcutaneous Enoxaparin (Tehran Chemical Company) 40 mg daily for one week after surgery. Inflammation. Timepoint: after surgery daily for 10 days. Method of measurement: Clinical evaluation. Pain. Timepoint: after surgery daily for 10 days. Method of measurement: Clinical evaluation. Differences in organ size. Timepoint: after surgery daily for 10 days. Method of measurement: Clinical evaluation. Tabriz University of Medical Sciences Approved 2023-01-09 Ethics Committee of Tabriz Medical School Floor 3, Center building N 2, Tabriz university of medical sciences, Golgasht street. Tabriz East Azarbaijan Iran (Islamic Republic of)