]>
IRCT20211109053014N1 IRCT 2021-12-19 Esfahan University of Medical Sciences Efficacy and safety of rivaroxaban and subcutaneous enoxaparin after spinal surgery Comparative efficacy and safety of rivaroxaban and subcutaneous enoxaparin in perevention of venous thrombo embolic events after spinal instrumentation 2021-12-06 anticipated 200 Complete https://irct.ir/trial/59933 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Random function of Excel software based on patient file number will be used for randomization. Patients undergoing spinal surgery were included in the Excel program based on the file number and were divided into case and control groups based on the random button. There were two groups of 35 people in total. By entering the file number in Excel program, then the random number is selected from the data analysis command. This study has 2 groups that can be numbered from 1 to 2, respectively. We also want 200 people in each group. As a result, sequences 1 to 2 should be repeated 100 times each time. It is clear that the repetition of each number occurs once in each group, so select 1 for repeating each number and 100 for repeating the sequence. In this way, 200 pieces will be produced. 3 Intravenous thromboembolism. Intervention 1: Intervention group: Administration of Rivarxaban 15 mg tablets once a day for 4 weeks after surgery from Dr. Obidi's factory. Intervention 2: Control group: Enoxaparin subcutaneous ampoule 1 mg / kg / day For 4 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Mehdi Shafiei
Isfahan University of Medical Sciences, Hezar Jarib St.,
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 0048 Mehdishafiei82@gmail.com Esfahan University of Medical Sciences scientific Mehdi Shafiei
Isfahan University of Medical Sciences, Hezar Jarib St.,
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 0048 Mehdishafiei82@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) All patients undergoing spinal cord surgery Patient consent to participate in the study High risk of the patient for venous thromboembolism no limit no limit Both Consumption of anticoagulants in the last 3 months Urine test with purpura-positive blood or cutaneous hematoma with active bleeding or high risk of bleeding Existence of active cancer as an underlying disease or cancer treated in the last 6 months Hospitalization and inactivity for more than 3 days Smoking more than 20 cigarettes a day Having a body mass index higher than 35 Pulmonary embolism and lower venous thrombosis O88.23 Thromboembolism in the puerperium Prevention Prevention Intervention group: Administration of Rivarxaban 15 mg tablets once a day for 4 weeks after surgery from Dr. Obidi's factory Control group: Enoxaparin subcutaneous ampoule 1 mg / kg / day For 4 weeks Intravenous Thromboembolism. Timepoint: In this study, hemorrhagic events caused by rivaroxaban and enoxaparin before surgery and 4 weeks after. Method of measurement: According to the patient's clinical symptoms. Esfahan University of Medical Sciences Approved 2020-10-07 Ethics committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jerib St., Shiraz Gate Isfahan Isfehan Iran (Islamic Republic of)