The Efficacy of BloodSTOP iX, Surgicel, and Gelfoam in Vascular Operations: First-in-Human Head-to-Head Study

Abstract

This study aims to compare the efficacy and safety of 3 different hemostatic agents in vascular surgeries in humans. Twenty-four patients were enrolled in the present study with 40 vascular anastomoses including 16 aortic and 24 femoral. The patients were randomized (computer-based) to either BloodSTOP iX, Gelfoam, or Surgicel. The hemostatic agent was applied at the site of the vascular anastomosis before declamping. The site of anastomosis was then observed for bleeding from the suture line for 2 min. If any bleeding was detected, blood was then collected for 5 min, and the time needed to stop bleeding was measured. A suction drain was fixed in the surgical bed to collect serous fluid postoperatively more than 48 h afterward. The volume of blood collected in 5 min was significantly lower in the BloodSTOP group compared with the other 2 hemostatics. There was a significant reduction in the mean time needed to stop bleeding from the anastomotic surface in the BloodSTOP group compared with the Surgicel and Gelfoam groups. In addition, Surgicel showed the highest rate of complication (46.2%) compared with BloodSTOP (7%). BloodSTOP iX dramatically reduced bleeding volume and time compared with the other hemostatic agents. Furthermore, it showed a lower complication rate and did not interfere with the healing process at the application sites.