Fibrinogen prophylaxis for reducing perioperative bleeding in patients undergoing radical cystectomy: A double-blind placebo-controlled randomized trial - 14/06/21
, Alireza Lashay, M.D. b, Nilofar Massoudi, M.D. a, ⁎ , Navid Nooraei, M.D. a , Mohsen Arian Nik, M.D. aAbstract |
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) www.irct.ir/, reference number: IRCT20191013045091N1.
Ethics code |
Shahid Beheshti University of Medical Sciences, reference number: IR.SBMU.RETECH.REC.1398.033.
Le texte complet de cet article est disponible en PDF.Highlights |
• | Fibrinogen concentrate reduces perioperative bleeding and needs for blood transfusion in RC. |
• | Fibrinogen compensates for the compromise of MAP, SpO2, ETCO2, temperature, and heart rate following RC. |
• | Prophylactic fibrinogen is associated with shorter surgery time and Intensive Care Unit and hospital stay following RC. |
Keywords : Fibrinogen, Bleeding, Radical cystectomy, Hemodynamic, Prophylaxis, Bladder
Plan
Vol 73
Article 110373- octobre 2021 Retour au numéro
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