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IRCT20130917014693N11 IRCT 2020-05-18 Shahid Beheshti University of Medical Sciences Evaluation of the Enoxaparin in the Prophylaxis of Deep Venous Thrombosis Evaluation of the Two Different Enoxaparin Regimen in the Prophylaxis of Deep Venous Thrombosis 2018-07-23 anticipated 60 Complete https://irct.ir/trial/48184 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, block randomization method was used and 15 blocks which consist of 4 patient in each block, will be generated through online randomization website. In each block, two patients allocated to group one (Enoxaparin at dose of 40 mg/day) and two patients allocated to group two (Enoxaparin at dose of 1 mg/kg/day). Then, sampling will be done through individual sampling method. 2-3 Deep vein thrombosi. Intervention 1: Control group: Patients receive pre-filled syringes of enoxaparin (manufactured by Alborz Daroo company) at dose of 40 mg/day through subcutaneous route. Intervention 2: Intervention group: Patients receive pre-filled syringes of enoxaparin (manufactured by Alborz Daroo company) at dose of 1 mg/kg/day through subcutaneous route. Yes - There is a plan to make this available What will be shared: All potential data can be shared after blinding When: Six mounts after results published To whom: Researchers working in academic institutions Conditions: For research purposes and meta analysis Where to obtain: Dr. Zahra Sahraei, Loghman Hakim Hospital, Kamali St, Makhsoos St, Tehran How to obtain: Official letter to the researchers Comments:
public Zahra Sahraei
Loghman Hakim Hospital, Kamali St, Makhsoos St
Tehran Iran (Islamic Republic of) 1333635445 +98 21 5541 9005 zahra.sahraei@yahoo.com Shahid Beheshti University of Medical Sciences scientific Dr. Zahra Sahraei
Loghman Hakim Hospital, Kamali St, Makhsoos St
Tehran Iran (Islamic Republic of) 1333635445 +98 21 5541 9005 zahra.sahraei@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age between 18 and 65 years old Padua risk score ≥ 4 points Signing the informed consent form 18 years 65 years Both Patients in shock state Acute kidney injury Chronic kidney injury History of hemorrhage in past one month Invasive surgical procedures which needs to enoxaparin discontinuation Pregnancy Lactation Thrombophilia Antithrombin deficiency Previous history of venous thrombosis Body mass index more than 35 kg/m2 Platelet less than 50000 cells/uL I82 Other venous embolism and thrombosis Prevention Prevention Control group: Patients receive pre-filled syringes of enoxaparin (manufactured by Alborz Daroo company) at dose of 40 mg/day through subcutaneous route. Intervention group: Patients receive pre-filled syringes of enoxaparin (manufactured by Alborz Daroo company) at dose of 1 mg/kg/day through subcutaneous route. The activity level of anti factor Xa. Timepoint: Three hours after third doses. Method of measurement: Chromogenic assay. Occurance rate of deep vein thrombosis. Timepoint: Daily. Method of measurement: Clinical examination and sonography is necessary cases. Occurrence rate of adverse drug reactions. Timepoint: Daily. Method of measurement: Observation. Shahid Beheshti University of Medical Sciences Approved 2018-07-02 Vice-Chancellor in Research Affairs - Shahid Beheshti University of Medical Sciences 3 rd floor, School of Medicine, Evin St, Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)