ScholarWorks@성균관대학교

초록

Background Hemogram is a novel biodegradable powdered hemostatic agent developed by binding calcium ions (Ca-2(+)) 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 (TM) 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 (TM) 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 (TM) 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 (TM) 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 (TM) 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 (TM) AH in patients undergoing gastrectomy. These findings suggest that Hemogram is a promising and clinically applicable hemostatic agent for surgical use.

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