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

Mohammad Fathi; Alireza Lashay; Nilofar Massoudi; Navid Nooraei; Mohsen Arian Nik

doi:10.1016/j.jclinane.2021.110373

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

J Clin Anesth. 2021 Oct:73:110373. doi: 10.1016/j.jclinane.2021.110373. Epub 2021 Jun 4.

Authors

Mohammad Fathi¹, Alireza Lashay², Nilofar Massoudi³, Navid Nooraei⁴, Mohsen Arian Nik⁵

Affiliations

¹ Critical Care Quality Improvement Research Center at Shahid Modarres Hospital, Department of Anesthesiology, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: [email protected].
² Department of Urology, Shahid Modarres Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
³ Critical Care Quality Improvement Research Center at Shahid Modarres Hospital, Department of Anesthesiology, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: [email protected].
⁴ Critical Care Quality Improvement Research Center at Shahid Modarres Hospital, Department of Anesthesiology, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: [email protected].
⁵ Critical Care Quality Improvement Research Center at Shahid Modarres Hospital, Department of Anesthesiology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

PMID: 34098395
DOI: 10.1016/j.jclinane.2021.110373

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.

Keywords: Bladder; Bleeding; Fibrinogen; Hemodynamic; Prophylaxis; Radical cystectomy.

Publication types

Randomized Controlled Trial

MeSH terms

Cystectomy* / adverse effects
Double-Blind Method
Fibrinogen
Hemorrhage
Hemostatics* / therapeutic use
Humans
Iran
Male
Middle Aged

Substances

Hemostatics
Fibrinogen