]>
IRCT20200526047576N1 IRCT 2021-04-01 Bagheiat-allah University of Medical Sciences effect of transamin in percutaneous nephrolithotomy surgery Comparative Study of the Hemostatic Effect of Transamin on percutaneous nephrolithotomy surgery 2021-02-19 anticipated 64 Complete https://irct.ir/trial/48472 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to randomize the study, a simple randomization method with individual units is used in such a way that patients are randomly assigned to one of the two intervention and control groups by choosing one of the cards containing code A or B.Cards A and B are each prepared in 32 pieces and placed in 64 exactly the same envelopes randomly and will be sealed.The cards will be placed in envelopes by someone outside the study, Blinding description: in order to avoid targeting and guiding the results, information related to the purpose of the project will be refused to the data analyzer. Efforts will be made to ensure that participants are anonymous and kept secret from the analyst. Participants will be analyzed in two unnamed groups. 3 kidneys stag horn stone. Intervention 1: According to the purpose of the project in the intervention group, 500 mg transamine ampoule containing 500 mg tranexamic acid in 5 ml by injection; During surgery, it will be used by an anesthesiologist and then every 8 hours to 48 hours by a respected research nurse. All patients are examined for vital signs every 6 hours by a respected ward nurse and a detailed description of the changes will be provided. Before starting the project, a training session will be held for all project partners and patients. All medicines will be provided by Caspian Tamin Company. No medication or placebo will be used for the control group. Intervention 2: Control group: in the control group, there will be no intervention in the patient's treatment process, and only to check and compare the control group with the intervention group, the vital signs of patients admitted to this group will be measured every 6 hours by a respected nurse partner. For these patients, a full explanation will be provided before the procedure begins. Yes - There is a plan to make this available What will be shared: Given the need to use the information in this study to create treatment protocols, all cases must be published accurately. When: Simultaneously with the end of the study To whom: physicians and academic researchers Conditions: The information in this study can be used to create a treatment protocol Where to obtain: University dissertations How to obtain: Due to the use of the information in this study in the university dissertation, the applicants can easily access all the information in this study. Comments:
public Fatemeh Heidari
Mollasadra Street. Vanak
Tehran Iran (Islamic Republic of) 1435916471 +98 21 8755 5250 Seyyedmojtabamirzadeh@yahoo.com Bagheiat-allah University of Medical Sciences scientific Seyyedmojtaba Mirzadeh Goodarzi
Mollasadra Street. Vanak
Tehran Iran (Islamic Republic of) 1435916471 +98 21 8755 5250 Seyyedmojtabamirzadeh@yahoo.com Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Patients should be between 18 and 60 years old Patients weigh between 60 kg and 99 kg 18 years 60 years Both History of anticoagulant use History of blood diseases or HB less than 11 or PLT less than 140000 N20.0 calculus of kidney Treatment - Surgery Treatment - Surgery According to the purpose of the project in the intervention group, 500 mg transamine ampoule containing 500 mg tranexamic acid in 5 ml by injection; During surgery, it will be used by an anesthesiologist and then every 8 hours to 48 hours by a respected research nurse. All patients are examined for vital signs every 6 hours by a respected ward nurse and a detailed description of the changes will be provided. Before starting the project, a training session will be held for all project partners and patients. All medicines will be provided by Caspian Tamin Company. No medication or placebo will be used for the control group. Control group: in the control group, there will be no intervention in the patient's treatment process, and only to check and compare the control group with the intervention group, the vital signs of patients admitted to this group will be measured every 6 hours by a respected nurse partner. For these patients, a full explanation will be provided before the procedure begins. Decreased hemoglobin loss. Timepoint: The day before surgery and then daily for 3 days. Method of measurement: Patient tests- series of CBC. Hb. Timepoint: Patients' hemoglobin levels will be measured a day before surgery and then daily for three days after surgery. Method of measurement: Complete blood count. Blood pressure. Timepoint: every 6 hr. Method of measurement: evaluation of blood pressure. Heart rate. Timepoint: every 6 hours. Method of measurement: evaluation oh heart rate. Respiratory rate. Timepoint: every 6 hours. Method of measurement: evaluation of respiratory rate. Bagheiat-allah University of Medical Sciences Approved 2021-01-09 ethic committee of baqiyatallah university of medical sciences baqiyatallah hospital,sheikh bahaie street, mollasadra Blvd, vanak square. tehran Tehran Iran (Islamic Republic of)