Miloš Bjelović1, Jaume Ayguasanosa2, Robin D Kim3, Miroslav Stojanović4, András Vereczkei5, Srdjan Nikolić6, Emily Winslow7, Sukru Emre8, Gary Xiao9, Jordi Navarro-Puerto2, Kecia Courtney2, Gladis Barrera2. 1. Department for Minimally Invasive Upper Digestive Surgery, Clinical Center of Serbia, Hospital for Digestive Surgery - First Surgical Hospital, Dr Koste Todorovica Street No 66, Belgrade, 11000, Serbia. milos.bjelovic@gmail.com. 2. Bioscience Research Group, Grifols, Barcelona, Spain. 3. Division of Transplantation and Advanced Hepatobiliary Surgery, Department of Surgery, University of Utah School of Medicine, Salt Lake City, UT, USA. 4. HBP unit Clinical Center Niš, General Surgery Clinic, Niš, Serbia. 5. Department of Surgery, Medical School, University of Pécs, Pécs, Hungary. 6. Clinic of Surgical Oncology, Institute of Oncology and Radiology of Serbia, Belgrade, Serbia. 7. Department of Surgery, University of Wisconsin Hospital and Clinics, Madison, WI, USA. 8. Department of Surgery: Transplant & Immunology, Yale-New Haven Hospital, New Haven, CT, USA. 9. Division of Multi-Organ Transplantation and Hepato-Pancreato-Biliary Surgery, Department of Surgery, Drexel University College of Medicine, Philadelphia, PA, USA.
Abstract
BACKGROUND: Local hemostatic agents have a role in limiting bleeding complications associated with liver resection. METHODS: In this randomized, phase III study, we compared the efficacy and safety of Fibrin Sealant Grifols (FS Grifols) with oxidized cellulose sheets (Surgicel®) as adjuncts to hemostasis during hepatic resections. The primary efficacy endpoint was the proportion of patients achieving hemostasis at target bleeding sites (TBS) within 4 min (T4) of treatment application. Secondary efficacy variables were time to hemostasis (TTH) at a later time point if re-bleeding occurs and cumulative proportion of patients achieving hemostasis by time points T2, T3, T5, T7, and T10. RESULTS: The rate of hemostasis by T4 was 92.8% in the FS Grifols group (n = 163) and 80.5% in the Surgicel® group (n = 162) (p = 0.01). The mean TTH was significantly shorter (p < 0.001) in the FS Grifols group (2.8 ± 0.14 vs. 3.8 ± 0.24 min). The rate of hemostasis by T2, T5, and T7 was higher and statistically superior in the FS Grifols group compared to Surgicel®. No substantial differences in adverse events (AE) were noted between treatment groups. The most common AEs were procedural pain (36.2 vs. 37.7%), nausea (20.9 vs. 23.5%), and hypotension (14.1 vs 6.2%). CONCLUSIONS: FS Grifols was safe and well tolerated as a local hemostatic agent during liver resection surgeries. Overall, data demonstrate that the hemostatic efficacy of FS Grifols is superior to Surgicel® and support the use of FS Grifols as an effective local hemostatic agent in these surgical procedures.
RCT Entities:
BACKGROUND: Local hemostatic agents have a role in limiting bleeding complications associated with liver resection. METHODS: In this randomized, phase III study, we compared the efficacy and safety of Fibrin Sealant Grifols (FS Grifols) with oxidized cellulose sheets (Surgicel®) as adjuncts to hemostasis during hepatic resections. The primary efficacy endpoint was the proportion of patients achieving hemostasis at target bleeding sites (TBS) within 4 min (T4) of treatment application. Secondary efficacy variables were time to hemostasis (TTH) at a later time point if re-bleeding occurs and cumulative proportion of patients achieving hemostasis by time points T2, T3, T5, T7, and T10. RESULTS: The rate of hemostasis by T4 was 92.8% in the FS Grifols group (n = 163) and 80.5% in the Surgicel® group (n = 162) (p = 0.01). The mean TTH was significantly shorter (p < 0.001) in the FS Grifols group (2.8 ± 0.14 vs. 3.8 ± 0.24 min). The rate of hemostasis by T2, T5, and T7 was higher and statistically superior in the FS Grifols group compared to Surgicel®. No substantial differences in adverse events (AE) were noted between treatment groups. The most common AEs were procedural pain (36.2 vs. 37.7%), nausea (20.9 vs. 23.5%), and hypotension (14.1 vs 6.2%). CONCLUSIONS:FS Grifols was safe and well tolerated as a local hemostatic agent during liver resection surgeries. Overall, data demonstrate that the hemostatic efficacy of FS Grifols is superior to Surgicel® and support the use of FS Grifols as an effective local hemostatic agent in these surgical procedures.
Entities:
Keywords:
Fibrin sealant; Liver resection; Local hemostasis; Oxidized cellulose; Parenchymous surgery
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