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IRCT20200202046344N1 IRCT 2020-09-29 Tehran University of Medical Sciences Aspirin in DVT Comparison of the effectiveness of Aspirin with Enoxaparin Sodium for prevention of deep vein thrombosis in Tibial fractures 2020-08-22 anticipated 446 Complete https://irct.ir/trial/49703 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: All patients were divided into two groups with 1:1 proportion. For the first group, Aspirin will be prescribed, and for the second group, Enoxaparin will be prescribed. Randomization is completely computer-based, Blinding description: In this study, only the researcher will know about the prescribed medication. Patients and their physicians won't know about anticoagulants that prescribed. hence, patients will get inform that prescribed drugs have anticoagulation effects. 3 Deep Vein Thrombosis. Intervention 1: Intervention group: patients with a tibial fracture will consume 80 mg Aspirin tablets produced by "Pars Daroo" every 12 hours for 35 days to prevent deep vein thrombosis. Intervention 2: Control group: patients with a tibial fracture will use Enoxaparin 30mg produced by "Osveh" every day for 35 days to prevent deep vein thrombosis. Yes - There is a plan to make this available What will be shared: The Trial result will completely present after completion of trial without the participant's personal information. When: after publication To whom: for the ones who ask for information Conditions: citation to the published article Where to obtain: Ali Sheikhy email: a-sheikhy@student.tums.ac.ir How to obtain: contact Ali Sheikhy via email. if the condition accepted, data will send. Comments:
public Ali Sheikhy
Imam khomeini
Tehran Iran (Islamic Republic of) 1967853916 +98 21 6634 8500 a-sheikhy@student.tums.ac.r Tehran University of Medical Sciences scientific Hossein Shafiei
Imam Khomeini
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6634 8500 dr_hshafiei@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Male and Females between 14 and 85 years old Tibial fractures with or without surgery indication 14 years 85 years Both Hip or femur fracture Major fracture except tibia DVT or PTE history Low platelet levels (lower than 100,000) Gustilo type 3B and higher open fractures Patients that have contraindication to use Aspirin or Heparin Patients that avoid to participate in the study Patients with chronic kidney disease that have lower GFR than 30 I82.4 Acute embolism and thrombosis of deep veins of lower extremity Treatment - Drugs Treatment - Drugs Intervention group: patients with a tibial fracture will consume 80 mg Aspirin tablets produced by "Pars Daroo" every 12 hours for 35 days to prevent deep vein thrombosis. Control group: patients with a tibial fracture will use Enoxaparin 30mg produced by "Osveh" every day for 35 days to prevent deep vein thrombosis. Incidence of deep vein thrombosis in lower extremity. Timepoint: At the end of first week, fourth week, 12th week, and 24th week after discharge. Method of measurement: Physical examinations an doppler ultra sonography. Peptic ulcer disease. Timepoint: At the end of first week, fourth week, 12th week, and 24th week after discharge. Method of measurement: Short questionnaire with 10 questions. Tehran University of Medical Sciences Approved 2020-07-22 Ethics Committee ,School of Medicine, Tehran University of Medical Sciences School of Medicine, Tehran University of Medical Sciences, Poor Sina street, Keshavarz blvd. Tehran Tehran Iran (Islamic Republic of)