Abstract
BACKGROUND: This study aimed to demonstrate the noninferior efficacy of TachoSil vs. TachoComb in Japanese patients undergoing liver resection and to assess the safety of TachoSil vs. TachoComb in these patients. METHODS: This randomized, double-blind, noninferiority study (JapicCTI-090684) involved participants scheduled for liver resection/living donors (age ≥ 20 years). TachoSil or TachoComb (1:1 allocation ratio) was applied to control persistent exudative bleeding after primary hemostasis during liver resection/removal for donation. The primary outcome was hemostasis 5 min after study treatment application. The 95% confidence interval (CI) for the difference in the proportion of participants with hemostasis 5 min after application of TachoSil/TachoComb was determined; noninferiority of TachoSil was indicated if the lower limit of the CI was ≥-14%. Adverse events (AEs) were recorded. RESULTS: All participants in the efficacy analysis (TachoSil: 54/54, 100%; TachoComb: 54/54, 100%) achieved hemostasis 5 min after study treatment application. Therefore, TachoSil was noninferior to TachoComb. All participants experienced ≥1 AE; however, none discontinued because of an AE. Most (≥97.8%) AEs were mild or moderate in severity. CONCLUSIONS: These findings confirm the safety profile and noninferior hemostatic efficacy of TachoSil compared with TachoComb.