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IRCT20230204057318N4 IRCT 2023-11-28 Shahid Beheshti University of Medical Sciences Comparing the effect of prophylactic administration of fibrinogen and tranexamic acid in radical radical cystectomy Comparing the effect of prophylactic administration of fibrinogen, tranexamic acid, or simultaneous use of both on perioperative bleeding in patients undergoing radical cystectomy and investigating clinical outcomes in the intensive care unit: a randomized double-blind study 2023-11-22 anticipated 105 Complete https://irct.ir/trial/73960 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For randomization, a simple randomization method was used using a table of random numbers and through the Random generator program of the Android version. In this randomization, patients who meet the criteria for entering the study are assigned a number before anesthesia, which will represent one of the three study groups, Blinding description: Due to the fact that the patients are unaware of the drug content, they are blinded to their group. Also, the drugs were prepared by a person outside the study group and the treatment group of patients with numbers, so the treatment group is also unaware of the colorless drug. Also, the people who perform the investigations of intraoperative bleeding and other postoperative outcomes are also blinded to the patient group. The data analyst will not know about the coding of the groups. 3 Intraoperative radical cystectomy. Intervention 1: Intervention group: After general anesthesia, patients in the fibrinogen group will be administered two grams of fibrinogen intravenously dissolved in 100 ml of distilled water. Intervention 2: Intervention group: After general anesthesia, patients in the tranexamic acid group will be administered 15 mg/kg of tranexamic acid intravenously dissolved in 100 ml of distilled water. Intervention 3: Intervention group: After general anesthesia, patients in the mixed group will be administered 5 mg/kg of tranexamic acid and 1g of fibrinogen intravenously dissolved in 100 ml of distilled water. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Alireza Shakeri
Imam Hossein Hospital, Shahid Madani st, Imam Ali Hwy.
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7343 0000 dr.alirezashakeri@gmail.com Shahid Beheshti University of Medical Sciences scientific Maede Karimian
Modarres Hospital, Saadat Abad intersection, Yadgar Imam highway
Tehran Iran (Islamic Republic of) 1998734383 +98 21 2207 4087 m_karimian1990@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients who are candidates for elective radical cystectomy surgery under general anesthesia with muscle relaxation and mechanical ventilation 40 years 80 years Male Patient on anticoagulant agent Having a known blood Abnormality or coagulopathy Chronic liver disease Chronic kidney disease with a serum creatinine level of > 2 mg/dL Preoperative plasma fibrinogen level of ≤150 or ≥ 400 mg/dL History of heart infarction, deep vein thrombosis, pulmonary embolism, stroke I97.42 Intraoperative hemorrhage and hematoma of a circulatory system organ or structure complicating other procedure Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: After general anesthesia, patients in the fibrinogen group will be administered two grams of fibrinogen intravenously dissolved in 100 ml of distilled water. Intervention group: After general anesthesia, patients in the tranexamic acid group will be administered 15 mg/kg of tranexamic acid intravenously dissolved in 100 ml of distilled water. Intervention group: After general anesthesia, patients in the mixed group will be administered 5 mg/kg of tranexamic acid and 1g of fibrinogen intravenously dissolved in 100 ml of distilled water. Intraoperative hemorrhage. Timepoint: Intraoperative. Method of measurement: Measuring of the suction bottle and bloody gauze and hemoglobin level. Hospitalization days. Timepoint: Postoperative period. Method of measurement: days. ICU length of stay. Timepoint: Postoperative period. Method of measurement: Days. Arterial blood gas. Timepoint: Intraoperative. Method of measurement: Arterial blood sampling. Morbidity (Pneumonia, wound infection, postoperative bleeding, Deep vein thrombosis, pulmonary thromboembolism, Stroke, Myocardial infarction). Timepoint: Postoperative. Method of measurement: Patient file. Packed red blood cells transfusion amount. Timepoint: perioperative. Method of measurement: Milliliters. Shahid Beheshti University of Medical Sciences Approved 2023-10-29 Ethics Committee of Shahid Beheshti University of Medical Sciences Yaman st., Shahid Chamran Hwy. Tehran Tehran Iran (Islamic Republic of)