A Prospective, Randomized, Phase III Study to Evaluate the Efficacy and Safety of Fibrin Sealant Grifols as an Adjunct to Hemostasis as Compared to Cellulose Sheets in Hepatic Surgery Resections

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.The following centers of the Fibrin Sealant on Hepatic Resection Clinical Investigation Study Group that contributed with patients are acknowledged: Vanderbilt University Medical Center, Nashville, TN, USA; Thomas Jefferson University, Philadelphia, PA, USA; Washington University School of Medicine, St Louis, MO, USA; Scientific Research Institute of Oncology n.a. N.N. Petrov, Moscow, Russia; Columbia University Medical Center, Center for Liver Disease and Transplantation, New York, NY, USA; Georgia Regents University, Augusta, GA, USA; Ann and Robert Lurie Children's Hospital of Chicago, Chicago, Il, USA; University of Nevada School of Medicine, Las Vegas, NV, USA; Federal State Budgetary Scientific Institution Russian Oncological Scientific Center n.a. N.N. Blokhin, Moscow, Russia; Carolinas Medical Center, Charlotte, NC, USA; Milton S. Hershey Medical Center, Hershey, PA, USA; Medical University of South Carolina, Charleston, SC, USA; Methodist University Hospital, Memphis, TN, USA; Walter Reed National Military Medical Center, Bethesda, MD, USA; University Children's Hospital, Belgrade, Serbia; Institute for Health Protection of Children and Youth of Vojvodina, Vojvodina, Serbia; and Semmelweis University, Budapest, Hungary . Funding: Fibrin Sealant GRIFOL