Version 1
: Received: 30 October 2024 / Approved: 31 October 2024 / Online: 31 October 2024 (15:07:17 CET)
How to cite:
Grimsby, J. L.; Szkolnicki, M. D.; Wood, K. A. Reevaluation of an Established In Vivo Gastric Vessel Bleed Model for Hemostatic Device Safety and Efficacy Testing. Preprints2024, 2024102578. https://doi.org/10.20944/preprints202410.2578.v1
Grimsby, J. L.; Szkolnicki, M. D.; Wood, K. A. Reevaluation of an Established In Vivo Gastric Vessel Bleed Model for Hemostatic Device Safety and Efficacy Testing. Preprints 2024, 2024102578. https://doi.org/10.20944/preprints202410.2578.v1
Grimsby, J. L.; Szkolnicki, M. D.; Wood, K. A. Reevaluation of an Established In Vivo Gastric Vessel Bleed Model for Hemostatic Device Safety and Efficacy Testing. Preprints2024, 2024102578. https://doi.org/10.20944/preprints202410.2578.v1
APA Style
Grimsby, J. L., Szkolnicki, M. D., & Wood, K. A. (2024). Reevaluation of an Established In Vivo Gastric Vessel Bleed Model for Hemostatic Device Safety and Efficacy Testing. Preprints. https://doi.org/10.20944/preprints202410.2578.v1
Chicago/Turabian Style
Grimsby, J. L., Matthew David Szkolnicki and Kevin Andrew Wood. 2024 "Reevaluation of an Established In Vivo Gastric Vessel Bleed Model for Hemostatic Device Safety and Efficacy Testing" Preprints. https://doi.org/10.20944/preprints202410.2578.v1
Abstract
For over a decade, endoscopic hemostatic powders have been used to manage upper gastrointestinal bleeding (UGIB). Various preclinical benchtop and animal models have been developed to evaluate these devices. Multiple companies have released hemostatic powders to market, assessing their safety and efficacy using an established porcine gastric vessel bleed model. This model simulates an aggressive arterial bleed, allowing prototypes to be tested under challenging conditions. It requires a surgeon to insert an artery segment into the gastric lumen and puncture it to produce a bleed. In our study, we tested a control group not included in prior research. We aimed to evaluate the relationship between intragastric pressure and bleed severity by injecting gas used to deliver hemostatic powder to the bleed site, without administering hemostatic powder. Our results indicate that elevated intragastric pressures alone can cause bleed cessation. Additional findings suggest that other factors in the model can lead to false positive hemostasis. This study highlights flaws in the porcine gastric vessel bleed model and underscores the need to develop more robust models for testing hemostatic devices, as no valid endoscopic bleed model currently exists. These experiments stress the importance of vetting preclinical models before acquiring efficacy data.
Keywords
in vivo bleed model; hemostatic powder; upper GI bleed model; severe gastric hemorrage; hemostasis; arterial bleed model; porcine bleed model
Subject
Medicine and Pharmacology, Gastroenterology and Hepatology
Copyright:
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
