Clinical Evaluation of the Hemostatic Efficacy and Safety of a Biodegradable Hemostatic Agent, Hemogram: A Comparative Study with Arista™ AH

Abstract

Background: Hemogram is a novel biodegradable powdered hemostatic agent developed by binding calcium ions (Ca²+) to carboxymethyl starch (CM-starch) and applying granulation technology to enhance blood absorption and hemostatic efficacy. This study aimed to evaluate the clinical efficacy and safety of Hemogram compared with the commercially available agent Arista™ AH in patients undergoing gastrectomy. Methods: This randomized controlled trial was conducted at Samsung Medical Center and included patients who experienced intraoperative oozing-type bleeding during gastrectomy. A total of 64 patients were enrolled and evenly randomized to receive either Hemogram (n = 32) or Arista™ AH (n = 32) for local hemostasis. The primary efficacy endpoint was the hemostatic success rate within 5 min. Secondary endpoints included hemostasis time, re-bleeding rate, number of hemostatic agent units used, transfusion volume, length of hospital stay, and incidence of adverse events. Results: Hemostatic success within 5 min was achieved in 100% (32/32) of the Hemogram group and 96.9% (31/32) of the Arista™ AH group, with no statistically significant difference between the two (P > 0.05). The mean time to hemostasis was 1.25 ± 0.80 min in the Hemogram group and 1.52 ± 0.85 min in the Arista™ AH group. No re-bleeding events were observed in the Hemogram group, while one case of re-bleeding (3.3%) was reported in the Arista™ AH group. There were no significant differences between groups in terms of transfusion volume, length of hospitalization, or adverse event rates. Conclusion: Hemogram demonstrated non-inferior hemostatic efficacy and safety compared to Arista™ AH in patients undergoing gastrectomy. These findings suggest that Hemogram is a promising and clinically applicable hemostatic agent for surgical use.