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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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230204057318N4
Enrollment
105
Registered
2023-11-28
Start date
2023-11-22
Completion date
Unknown
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intraoperative radical cystectomy. Intraoperative hemorrhage and hematoma of a circulatory system organ or structure complicating other procedure

Interventions

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. Interv

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: Patients who are candidates for elective radical cystectomy surgery under general anesthesia with muscle relaxation and mechanical ventilation

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Intraoperative hemorrhage. Timepoint: Intraoperative. Method of measurement: Measuring of the suction bottle and bloody gauze and hemoglobin level.

Secondary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAlireza Shakeri

Shahid Beheshti University of Medical Sciences

dr.alirezashakeri@gmail.com+98 21 7343 0000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026