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IRCT20181031041515N1 IRCT 2019-06-01 Islamic Azad University The Effects of Tranexamic Acid and Vitamin K in the prevention of hemorrhage in TURP surgery. Comparison of the effects of Tranexamic Acid and Vitamin K in the prevention of hemorrhage in TURP surgery. 2018-11-06 anticipated 75 Complete https://irct.ir/trial/35025 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The computerized block randomization (block sizes of 3 and 9) will carried out in this study. An independent clinical epidemiologist, who will not involved in the conduct of the study used a computerized block randomization program (STATA14 software) uses to produce the allocation codes.The randomization sequences will be concealed in lightproof, sealed envelopes.The research assistant opened sealed, numbered, opaque envelopes containing allocation codes. The eligible participants will be randomized to three equal groups (normal saline group, transxamic acid group and vitamin K group) according to the randomization list after signing informed consent form, Blinding description: Patients will not be aware of the type of medication they receive and the second executor of the research project will complete the questionnaire at the end of the treatment without knowledge of the three groups. Also the data will be analyzed without any information about group selection. 2-3 Benign prostate Hyperplasia. Intervention 1: Intervention group: Ampol of 1 vial of Transamin 500 mg (Caspian Company Rasht Drug) will be injected into the serum during an operation in the Tranexamic Acid group. Intervention 2: Intervention group: Vitamin K ampol with dosage 10 mg (Osvah Pharmaceutical company) will be injected intra-muscularly in the vitamin K group 8 hours prior to surgery. Intervention 3: Control group: The normal serum saline (Tehran Pharmacy Company) will be administered to the control group during surgery. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Yousef Kolookhi
No.45 , First Alley , Mofateh St , station St
Shahroud Iran (Islamic Republic of) 3616643417 +98 23 3224 2487 dryousefkolookhianestezi@gmail.com Islamic Azad University scientific Yousef Kolookhi
University Blvd - Shahrud Islamic Azad University
Shahroud Iran (Islamic Republic of) 3619943189 +98 23 3239 4530 dryousefkolookhianestezi@gmail.com Islamic Azad University Iran (Islamic Republic of) Male gender 60 to 90 year-old Satisfaction for performing TURP surgery 60 years 90 years Male Coagulation disorders (hemophilia and ...) Liver Disease (Cirrhosis and ...) Uses of anticoagulant medication (Warfarin and Heparin and Plavix) History of heart disease History of thrombotic stroke N40 Enlarged prostate Treatment - Drugs Treatment - Drugs Placebo Intervention group: Ampol of 1 vial of Transamin 500 mg (Caspian Company Rasht Drug) will be injected into the serum during an operation in the Tranexamic Acid group. Intervention group: Vitamin K ampol with dosage 10 mg (Osvah Pharmaceutical company) will be injected intra-muscularly in the vitamin K group 8 hours prior to surgery. Control group: The normal serum saline (Tehran Pharmacy Company) will be administered to the control group during surgery. Bleeding status after TURP surgery. Timepoint: Within 48 hours after surgery. Method of measurement: Volume of fluid in the urethra for hematuria, the amount of hemoglobin before and after surgery. The amount of bleeding during and after the TURP operation. Timepoint: During and after the TURP operation. Method of measurement: Hemoglobin level and serum volume of used washing. Islamic Azad University Approved 2018-09-29 Ethics Committee on Biomedical Research of the Islamic Azad University of Shahroud Branch Islamic Azad University of Shahrood Branch, Blvd university,Shahroud Town Shahroud Semnan Iran (Islamic Republic of)