Safety Analysis of a Hemostatic Powder in a Porcine Model of Acute Severe Gastric Bleeding

Abstract

The hemostatic powder achieved initial hemostasis (even in animals with spurting arterial bleeding) with no bowel obstruction or unintended luminal effects, no local or regional particulate effects, no systemic embolic effects, and no systemic coagulopathic effects.

Hemostatic powder spray: a new method for managing gastrointestinal bleeding

“…Of the 19 studies, 6 were case reports [Fujita, 2012;Granata et al 2013;Sargon and Laurie, 2013;Stanley et al 2013;Paganelli et al 2014;Moosavi et al 2013] and 13 were case series. A total of 17 studies studied humans (234 cases) [Sung et al 2011;Chen et al 2012;Fujita et al 2012;Granata et al 2013;Leblanc et al 2013;Ibrahim et al 2013;Smith et al 2013;Sargon and Laurie, 2013;Stanley et al 2013;Soulellis et al 2013;Yau et al 2014;Smith et al 2014;Holster et al 2014;Sulz et al 2014;Paganelli et al 2014;Chen et al 2014;Moosavi et al 2013], while the remaining two performed in the United States involved porcine models (11 cases) [Giday et al 2011[Giday et al , 2013. The mean age of human subjects was 54.9 years.…”

Safety and Efficacy of Hemospray®in Upper Gastrointestinal Bleeding

“…Perforation appears unlikely because the pressure of carbon dioxide is only 12 mmHg when the catheter is placed at 1 cm to 2 cm from the target lesion (10). Embolization also appears unlikely based on the safety study performed in a porcine model by Giday et al (17) using a sevenfold greater dose of Hemospray than that used in most clinical cases; the authors found no histological evidence of powder embolization in systemic tissues including the spleen. In addition, case reports and series in humans have not reported the theoretical risks of Hemospray including thromboembolism, bowel perforation, bowel obstruction, coagulopathy, allergic reaction and powder inhalation (3)(4)(5)(6)(7)(8)(9)(10)(11)(12)(13).…”

Hemospray® during Emergency Endoscopy: Indonesia’s First Experience from 37 Patients

“…Another possible adverse outcome was powder embolization, yet the risk was very low since the pressure of the carbon dioxide used to propel the powder was unlikely to overcome the blood pressure [15]. Giday et al [24] found no evidence of powder embolization histologically in the systemic tissues including the spleen, even when the given dose was 7-fold greater than most clinical use.…”