Experimental Study Of Hemostatic Device In Polysaccharide Surgery For Arterial Hemorrhage Of Upper Digestive Tract

Objective The study is to validate the efficacy and safety of EndoClot PHS in an animal model of spurting/pulsatile arterial upper gastrointestinal bleeding(Forrest 1a)and peptic ulcer oozing type bleeding(Forrest 1b)in comparison with the FDA 510(k)cleared product Hemospray which has the same intended use.Methods 12 animals were randomized to test group or control group.All experimental pigs underwent aseptic laparotomy under general anesthesia.The right gastric omentum artery was isolated,and the free artery was implanted and exposed to the gastric cavity through a 1 cm gastric incision in the gastric wall.Heparin was injected intravenously to twice the normal ACT and a needle knife was used to puncture the blood vessels implanted in the gastric cavity,causing jet or pulsatile bleeding.The experimental group used Endoclot PHS to spray the wound to stop bleeding,and the control group used Hemospray.Gastroscopy was continued for 30 min.Compare the time to effective hemostasis,the amount of hemostatic particles used,the blockage of the powder feeding tube and the number of replacements.After 10 days,the experimental pigs were euthanized for pathological dissection.Results All experimental pigs achieved jet or pulsatile bleeding.The average amount of hemostatic particles used to achieve effective hemostasis in the Endoclot PHS group was less than that in the HemoSpray group,and the difference was statistically significant(P<0.05).The average time to achieve effective hemostasis and the number of clogging and replacement of the powder delivery tube in the Endoclot PHS group were less than in the Hemospray group.In addition,the gas source of Endoclot PHS group was stable,and the visual field under the endoscope was clear.Neither the Endoclot PHS group nor the HemoSpray group had gastric lesions,perforation,or embolism,blood glucose,blood routine,and liver and kidney function were normal,and no thrombosis or embolism of the main organs occurred.Conclution Under the conditions of this test,the EndoClot polysaccharide surgical hemostasis device(EndoClot PHS)was verified to be safe and effective for heparinized upper gastrointestinal arterial ejection or pulsatile bleeding(Forrest 1a).