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

Comparing the effect of prophylactic administration of fibrinogen, tranexamic acid, or simultaneous use of both on perioperative bleeding in patients undergoing radical cystectomy

En Clinical trial with 3 groups, with parallel groups, double blind, randomized, phase 3 on 105 patients. For randomization, a simple randomization method is used using a table of random numbers.

After the ethics committee's approval and obtaining the patient's consent, 105 candidates for radical cystectomy in modarres Hospital who meet the criteria as mentioned above will be included in the study. Patients are assigned to one of the 3 groups by simple randomization method. Individuals responsible for randomization from the research team will not be responsible for examining the dependent variable. The data analyst will not know about the coding of the groups.

Patients who are candidates for elective radical cystectomy surgery under general anesthesia with muscle relaxation and mechanical ventilation without a history of anticoagulant therapy, 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 or history of heart infarction, deep vein thrombosis, pulmonary embolism, stroke

After general anesthesia, patients are assigned to one of 3 groups that receive 2 grams of fibrinogen, or 15 mg/kg of tranexamic acid, or a combination of both as 5 mg/kg of tranexamic acid and one gram of fibrinogen intravenously.

Intraoperative hemorrhage

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.

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.

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