Fibrinogen prophylaxis for reducing perioperative bleeding in patients undergoing radical cystectomy: A double-blind placebo-controlled randomized trial

Critical Care Quality Improvement Research Center at Shahid Modarres Hospital, Department of Anesthesiology, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: m.fathi@sbmu.ac.ir. Department of Urology, Shahid Modarres Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Critical Care Quality Improvement Research Center at Shahid Modarres Hospital, Department of Anesthesiology, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: massodi@sbmu.ac.ir. Critical Care Quality Improvement Research Center at Shahid Modarres Hospital, Department of Anesthesiology, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: n_nouraee@sbmu.ac.ir. Critical Care Quality Improvement Research Center at Shahid Modarres Hospital, Department of Anesthesiology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Journal of clinical anesthesia. 2021;73:110373

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Abstract
OBJECTIVE Excessive bleeding is an important complication of radical cystectomy. We aimed to assess whether preoperative administration of fibrinogen decreases perioperative bleeding and improves the outcome of radical cystectomy. DESIGN Double-blinded randomized trial with two parallel arms. SETTING The study was conducted in the department of surgery at a teaching hospital affiliated with a University of Medical Sciences. PATIENTS In total, 70 men undergoing radical cystectomy were randomized to fibrinogen (n = 35) and placebo-control groups. Mean (SD) age was 64.7 (7.4) years. INTERVENTIONS The intervention group received 2 g fibrinogen concentrate diluted in 100 ml distilled water, and the control group received 100 ml normal saline; both intravenously 15 ̶ 30 min before the start of the surgery. OUTCOME MEASURES The primary outcome was the amount of perioperative blood loss. The secondary outcomes were hemodynamic features and vital signs. MAIN RESULTS Fibrinogen significantly decreased the volume of blood loss (p < 0.001) and the total number of transfused packed-cell units per group (38 vs. 115 units); and compensated the decrease of HCO3 (p = 0.030), the mean arterial pressure (p < 0.001), hemoglobin O2 saturation (p = 0.001), heart rate (p < 0.001), and temperature (p < 0.001) throughout the surgery compared with the placebo. Patients in the fibrinogen group had shorter Intensive Care Unit (p = 0.001) and hospital (p < 0.001) stay. We did not find any adverse reaction in our patients receiving fibrinogen concentrate. CONCLUSION Fibrinogen concentrate reduces perioperative bleeding and the need for blood transfusion in radical cystectomy. It improves the outcomes of the surgery and decreases patients' length of stay in the healthcare system following radical cystectomy. REGISTRATION Iranian Registry of Clinical Trials (IRCT) http://www.irct.ir/, reference number: IRCT20191013045091N1. ETHICS CODE Shahid Beheshti University of Medical Sciences, reference number: IR.SBMU.RETECH.REC.1398.033.
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Language : eng
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