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IRCT20180625040232N2 IRCT 2020-03-25 Oroumia University of Medical Sciences Effect of topical tranexamic on hemoglobin Assessment of topical tranexamic effect on postoperative hemoglobin in patient undergoing percutaneous nephrolithotomy 2020-01-01 anticipated 90 Complete https://irct.ir/trial/46439 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, all eligible patients were assigned to control and intervention (tranexamic ) groups using random sequence extraction from the computer (via www.randomization.com) and simple randomization. The resulting random numbers, i.e. the allocation of patients to groups, was concealed using sealed envelopes, Blinding description: In this study, clinical care giver and statistical analyzer were not aware of groups assigned to patients. 3 Hemorrhagia. Intervention 1: Intervention group: In the intervention group, 1 gr of tranexamic acid (Caspian Tamin Pharmaceutical Company) is diluted in 100 ml normal saline and injected into nephrostomy drain (not intravenously) immediately after surgery. The catheter is then clamped for 30 minutes to prevent leakage. Intervention 2: Control group: In this group, routine procedures were performed after percutaneous nephrolithotomy. Therefore, tranexamic acid is not routinely administered, so it was not injected in this group. Yes - There is a plan to make this available What will be shared: Any information without the need for patients' names will be available When: Six months after publication To whom: Faculty members of medical universities Conditions: For research purposes Where to obtain: Email to Dr. Saman Farshid farshid.s@umsu.ac.ir How to obtain: Email to Dr. Saman Farshid farshid.s@umsu.ac.ir Comments:
public Saman Farshid
Imam Khomeini hospital, Ershad Ave, Urmia
Urmia Iran (Islamic Republic of) 5714783734 +98 44 3346 9931 samanf63@gmail.com Oroumia University of Medical Sciences scientific Saman Farshid
Imam Khomeini hospital, Ershad Ave, Urmia
Urmia Iran (Islamic Republic of) 5714783734 +98 44 3346 9931 samanf63@gmail.com Oroumia University of Medical Sciences Iran (Islamic Republic of) Age between 18-65 years ASA class <III Not having coagulopathy 18 years 65 years Both Need to embed Double J Prediction of need to transfusion during surgery Having dyscrasia D68.32 Hemorrhagic disorder due to extrinsic circulating anticoagulants Treatment - Drugs Treatment - Drugs Intervention group: In the intervention group, 1 gr of tranexamic acid (Caspian Tamin Pharmaceutical Company) is diluted in 100 ml normal saline and injected into nephrostomy drain (not intravenously) immediately after surgery. The catheter is then clamped for 30 minutes to prevent leakage. Control group: In this group, routine procedures were performed after percutaneous nephrolithotomy. Therefore, tranexamic acid is not routinely administered, so it was not injected in this group. Hemoglobin. Timepoint: Before surgery and 48 hours after surgery. Method of measurement: Blood sampling. Hospital stay days. Timepoint: Once, at the time of discharge. Method of measurement: Calculating hospital stay days from admission to discharge. Stone free rate (SFR). Timepoint: Once, when leaving the operating room. Method of measurement: Using Portable Radiological Device (C-arm). Oroumia University of Medical Sciences Approved 2019-12-30 Ethics committee of Urmia University of Medical Sciences Urmia University of Medical Sciences-Resalat Blvd-Emergency Alley, Urmia, Vest Azarbaijan Urmia West Azarbaijan Iran (Islamic Republic of)