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IRCT20141209020258N140 IRCT 2020-04-08 Arak University of Medical Sciences Comparison of two kind of drug oral and subcutaneous in prevention of deep vein ‎thrombosis in patients admitted to intensive care unit Comparison of Enoxaparin versus oral Rivaroxaban in prevention of deep vein ‎thrombosis in patients admitted to intensive care unit 2018-10-23 anticipated 98 Complete https://irct.ir/trial/44277 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple individual randomization will be used with envelopes in two groups A and B.‏ In this method, we will select a number of cards or letters as an intervention group and the same ‎number of cards for the control group, then the cards will be shuffled. One card will be taken out and its ‎allocation is registered and the card was returned to the other cards after leaving. Then the cards ‎are shuffled again and we will take another card. This process continues to reach a random sequence ‎according to sample size, Blinding description: This study is single blind. Researcher who complete questionnaire and analyzer are blind (double blind). Outcome assessor and analyzer don't aware from grouping.The person evaluating the outcome is unaware of the grouping. Groups A and B are available to analyzer and outcome assessor. 3 Thromboembolism. Intervention 1: Intervention group: We treat patients with 15 milligram Rivaroxaban tablets daily orally or oral gavage until they have the order to get out of bed. Intervention 2: Control group: We treat patients with 40 milligram Enoxaparin ampule daily subcutaneously until they have the order to get out of bed. Yes - There is a plan to make this available What will be shared: When we publish article in journal When: After the article is published To whom: Researcher in university Conditions: If there are additional questions Where to obtain: Dr Behnam Mahmoudie How to obtain: They have to write letters to the professors and the university Comments:
public Dr Behnam Mahmodie
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 mahmodie@arakmu.ac.ir Arak University of Medical Sciences scientific Dr Behnam Mahmodie
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 mahmodie@arakmu.ac.ir Arak University of Medical Sciences Iran (Islamic Republic of) Ages 18 to 60 years Possibility to gavage or start oral feeding Glomerular filtration above 50% Patients hospitalized in intensive care units 18 years 60 years Both Contraindications to anti-coagulant Allergy to Rivaroxaban O88.23 Embolism and thrombosis of unspecified artery Treatment - Drugs Treatment - Drugs Intervention group: We treat patients with 15 milligram Rivaroxaban tablets daily orally or oral gavage until they have the order to get out of bed. Control group: We treat patients with 40 milligram Enoxaparin ampule daily subcutaneously until they have the order to get out of bed. Incidence of thromboembolism. Timepoint: After the end of treatment. Method of measurement: Physical examination. Arak University of Medical Sciences Approved 2018-10-21 Ethics Committe Arak University Of Medical Sciences Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak Arak Markazi Iran (Islamic Republic of)