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IRCT20211121053127N1 IRCT 2021-12-21 Esfahan University of Medical Sciences Efficacy of injectable transamine in patients with benign prostatic hyperplasia Evaluation of the effectiveness of injectable transamine administration in reducing the volume of bleeding in open trans-vesicular prostatectomy in patients with benign prostatic hyperplasia 2021-12-22 anticipated 70 Complete https://irct.ir/trial/60208 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study will be performed blindly with a simple randomization method using Excel software. Random function of Excel software based on patient file number will be used for randomization. Patients with benign prostatic hyperplasia entered 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 35 people in each group. As a result, sequences 1 to 2 should be repeated 35 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 35 for repeating the sequence. In this way, 70 units will be produced, Blinding description: In this study, the patient did not know whether she was in the injectable transamine group or in the placebo group. In the placebo group, distilled water or normal saline is injected instead of medicine Which is similar in shape, color, state, smell and in every way, similar to medicine. 2 Benign prostate enlargement. Intervention 1: Intervention group: Injectable transamine * Quantity: (1 gram injection during surgery and 48 hours after surgery, 3 times a day injection) After induction of anesthesia, transamine 10 mg per kg will be infused for 10 minutes * Content: Transamine * Duration of treatment: 48 hours after surgery * Chemical composition: Pay attention to the drug leaflet in the box. * Consumption dose: 1 gram * How to use: injection * Manufacturer: Razi. Intervention 2: Control group: Plasibo (In the placebo group, distilled water or normal saline is injected instead of medicine.) 1 gram of injection during the operation and 48 hours after the operation, 3 times a day injection * Content: Plasibo in terms of color, shape, volume, condition, odor. ... is similar to the main drug * Duration of treatment: 48 hours after surgery ** Dosage: 1 gram * How to use: injection * Manufacturer: Razi. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Mehrdad Mohammadi sichani
Al-Zahra Educational and Medical Center, Sofeh Boulevard
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 M_mohammadi@med.mui.ac.ir Esfahan University of Medical Sciences scientific Mehrdad Mohammadi sichani
Al-Zahra Educational and Medical Center, Sofeh Boulevard
Isfahan Iran (Islamic Republic of) alzahra@mui.ac.ir +98 31 3620 2020 M_mohammadi@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients undergoing Prostatectomy Patients who are willing to participate in the study 18 years no limit Both Use of anticoagulants such as aspirin and dipyridamole Prothrombin time and partial thromboplastin time are high for whatever reason Any history of thrombotic events History of bleeding disorders Chronic kidney disease (serum creatinine greater than 180 micromoles per liter). D29.1 Benign neoplasm of prostate Treatment - Drugs Treatment - Drugs Intervention group: Injectable transamine * Quantity: (1 gram injection during surgery and 48 hours after surgery, 3 times a day injection) After induction of anesthesia, transamine 10 mg per kg will be infused for 10 minutes * Content: Transamine * Duration of treatment: 48 hours after surgery * Chemical composition: Pay attention to the drug leaflet in the box. * Consumption dose: 1 gram * How to use: injection * Manufacturer: Razi Control group: Plasibo (In the placebo group, distilled water or normal saline is injected instead of medicine.) 1 gram of injection during the operation and 48 hours after the operation, 3 times a day injection * Content: Plasibo in terms of color, shape, volume, condition, odor. ... is similar to the main drug * Duration of treatment: 48 hours after surgery ** Dosage: 1 gram * How to use: injection * Manufacturer: Razi Bleeding volume. Timepoint: 24 hours after surgery. Method of measurement: The amount of ml of blood removed from the patient's body. Esfahan University of Medical Sciences Approved 2021-08-13 Ethics committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jerib St., Shiraz Gate Isfahan Isfehan Iran (Islamic Republic of)