ABSTRACT
Objective:To study the efficacy and safety of EndoClot polysaccharide hemostatic system (EndoClot PHS) for heparinized arterial hemorrhage of upper digestive tract (Forrest Ⅰa) in animal model.Methods:Twelve experimental pigs were randomly divided into the test group ( n=6) and the control group ( n=6) by simple random grouping method. Gastric arterial hemorrhage models were established. Endoclot PHS and Hemospray were used to spray on the wound to stop bleeding in the test group and the control group respectively. The time of effective hemostasis, the amount of hemostatic particles used, and the blockage of the powder feeding tube and its replacement were compared between the two groups. The survival and complications of experimental pigs were observed after the operation. In 10 days after the operation, the experimental pigs were euthanized for pathological dissection. Results:Spurting or pulsatile bleeding was achieved in all experimental pigs. There were significant differences in the time of effective hemostasis (8.75±0.84 min VS 9.83±0.62 min, t=-2.53, P=0.030) and the amount of hemostatic particles used to achieve effective hemostasis (6.71±0.39 g VS 14.10±1.62 g, t=-10.86, P<0.001) between the test group and the control group. There was no significant difference in the occurence of clogging or the replacement of powder feeding pipes between the two groups (0.64±0.02 times VS 0.67±0.04 times, t=-1.64, P=0.131). In addition, the gas source of the test group was stable, and the visual field under the endoscope was clear. Neither the test group nor the control group had gastric lesions, perforation, or embolism. The blood glucose, blood routine, and liver and kidney functions were normal, and no thrombosis or embolism of the main organs occurred in either group. Conclusion:EndoClot PHS is safe and effective for heparinized upper gastrointestinal arterial hemorrhage (Forrest Ⅰa) in animal models.
ABSTRACT
There are no recommendations for assessing the effect of potential drugs on the hemostatic system irrespective of theanticipated application area, which leads to long-term financial losses. The examples of papaverine hydrochloride,pentoxifylline, and acetylsalicylic acid demonstrated the potential of thromboelastography (TEG) as a screening methodfor products that affect the hemostatic system, the safety assessment method for hypercoagulability/hypocoagulability,and the thrombosis model, using tissue factor (TF) or thrombin. The blood of male donor patients (n = 60) with acutede novo thrombosis (n = 90) was used. Using activated TEG, in vitro hemostatic system hyperactivity modeling wascarried out with the blood of healthy male donors (n = 20); 0.2 М CaCl2, recombinant TF, and thrombin were used asTEG activators. General coagulation tendency (R), functional activity of thrombocytes and fibrinogens (МА, Angle),fibrinolysis activity, and physical–mechanical properties of formed clots were determined from thromboelastograms.The effect of anti-aggregants was characterized by a significant decrease in МА. The potential of TEG as a screeningmethod for assessing the effect of new pharmacological agents on the hemostatic system at preclinical stage wasdemonstrated; the possibility of safety assessment for hypercoagulability/hypocoagulability was shown; and thecomparability of hemostatic parameters of the patients with thrombosis and TEG, activated by TF and/or thrombinwas demonstrated.