Comparing the effect of prophylactic administration of fibrinogen and tranexamic acid in radical radical cystectomy
Phase 3
Recruiting
- Conditions
- Intraoperative radical cystectomy.Intraoperative hemorrhage and hematoma of a circulatory system organ or structure complicating other procedureI97.42
- Registration Number
- IRCT20230204057318N4
- Lead Sponsor
- Shahid Beheshti University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 105
Inclusion Criteria
Patients who are candidates for elective radical cystectomy surgery under general anesthesia with muscle relaxation and mechanical ventilation
Exclusion Criteria
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Intraoperative hemorrhage. Timepoint: Intraoperative. Method of measurement: Measuring of the suction bottle and bloody gauze and hemoglobin level.
- Secondary Outcome Measures
Name Time Method 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.