1. 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.
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Bjelović, Miloš, Ayguasanosa, Jaume, Kim, Robin D., Stojanović, Miroslav, Vereczkei, András, Nikolić, Srdjan, Winslow, Emily, Emre, Sukru, Xiao, Gary, Navarro-Puerto, Jordi, Courtney, Kecia, Barrera, Gladis, on behalf of the investigators of the Fibrin Sealant Grifols in Hepatic Resection Clinical Investigation Study Group, and investigators of the Fibrin Sealant Grifols in Hepatic Resection Clinical Investigation Study Group
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FIBRIN ,CELLULOSE ,HEMOSTASIS ,ONCOLOGIC surgery ,SURGICAL complications - 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. [ABSTRACT FROM AUTHOR]- Published
- 2018
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