Preprint Article Version 1 This version is not peer-reviewed

Reevaluation of an Established In Vivo Gastric Vessel Bleed Model for Hemostatic Device Safety and Efficacy Testing

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. 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. Preprints 2024, 2024102578. 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

Comments (0)

We encourage comments and feedback from a broad range of readers. See criteria for comments and our Diversity statement.

Leave a public comment
Send a private comment to the author(s)
* All users must log in before leaving a comment
Views 0
Downloads 0
Comments 0


×
Alerts
Notify me about updates to this article or when a peer-reviewed version is published.
We use cookies on our website to ensure you get the best experience.
Read more about our cookies here.