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IRCT20181128041781N1 IRCT 2019-10-14 Sabzevar University of Medical Sciences Effect of Rivrvoxaban on the Prevention of Deep Vein Thrombosis and Pulmonary Embolism Comparison of the Effect of Rivaroxaban and Enoxaparin in Coagulation Setting for Lower Limb Fracture Surgerys to Prevent Deep Vein Thrombosis and Pulmonary Embolism 2019-02-07 anticipated 50 Complete https://irct.ir/trial/35710 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: The Allocation of Treatment is done Randomly by Cards. Individual Randomization Unit, Blinding description: The Allocation of Treatment is done Randomly(The Permutation Block Method that Blinds Donors to Treatment) and by Cards that the Person who is Allocating it is not Aware of its Content.The Results of Color Doppler Ultrasound are not known from the type of Treatment Prescribed, which Includes Enoxaparin 40 mg Subcutaneous Daily and Rivaroxaba 10 mg Daily Oral.The Person Who Cares for the Clinic is also not Aware of the Contents of the Cards. The Examination of the Entended outcome Include Deep Vein Thrombosis or Pulmonary Embolism after Surgery, Which is Evaluated one Month after Starting Treatment and Observation of the Symptoms of Deep Venous Thrombosis (Warmth, Pain, Swelling, Especially the Back of the Leg) and Pulmonary Embolism (Dyspnea, Pleuretic Pain, Orthopnea), The Ultrasound Results are not known by the Medical Specialist who is Assigned the Type of Treatment. In Order to Bblind the Evaluator of Treatment, an Attempt was made to use a Separate Individual from the Therapist (who is Medical Student in this Study). to Blind the Patients, Patients Receiving Enoxaparin are also given Folic Acid Tablet, and Patients Receiving Rivaroxaban are given Distilled Water Injections. 3 Condition 1: Deep Vein Thrombosis. Condition 2: Pulmonary Embolism. Intervention 1: Intervention group: People who receive oral Rivaroxaban 10mg Daily for 12 Days then at the same time, distilled water were injected to those. Intervention 2: Control group: People who receive Enoxaparin Subcutaneous 40mg for 10 Days then at the same time, a folic acid tablet daily was taken to those. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more Information
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Sabzevar Iran (Islamic Republic of) 9618614341 +98 51 4464 0115 salar.abdi.1371@gmail.com Sabzevar University of Medical Sciences Iran (Islamic Republic of) All People over the Age of 20 Years who are Candidates for Anticoagulant Therapy 20 years no limit Both History of Hypersensitivity Reaction to either of the Two Drugs Severe Bleeding Pregnancy and Lactation History of Recent Labor or any Recent Injury Having Liver Disease or any other Disease that Leads to an Increased Risk of Bleeding. I80.2 i26 Phlebitis and thrombophlebitis of other deep vessels of lower extremities Deep vein thrombosis Pulmonary embolism Prevention Prevention Intervention group: People who receive oral Rivaroxaban 10mg Daily for 12 Days then at the same time, distilled water were injected to those Control group: People who receive Enoxaparin Subcutaneous 40mg for 10 Days then at the same time, a folic acid tablet daily was taken to those Deep Vein Thrombosis. Timepoint: One Month after Receiving Treatment. Method of measurement: Examinations and Color Doppler Ultrasound. Pulmonary Embolism. Timepoint: One Month after Receiving Treatment. Method of measurement: Examinations and Color Doppler Ultrasound. Sabzevar University of Medical Sciences Approved 2018-12-03 Ethics committee of Sabzevar University of Medical Sciences Campus of the University of Medical Sciences, Above the Shohadaye Gomnam, Shohadaye Hastei Blvd. Sabzevar Razavi Khorasan Iran (Islamic Republic of)