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

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Abstract

Background

Non-variceal upper gastrointestinal (UGI) bleeding is a common condition that requires prompt lifesaving therapy and traditional endoscopic treatments require high technical proficiency to perform.

Aims

This study was conducted to identify any local or systemic histopathologic effects of a hemostatic powder in a porcine model of active, severe, non-variceal UGI hemorrhage.

Methods

This prospective, non-blinded animal study was performed in accordance with Good Laboratory Practice and Animal Care and Use Guidelines. Six animals underwent gastrotomy and creation of a looped vascular bundle, which was placed into the stomach lumen. The transplanted vascular bundle was punctured with an endoscopic needle–knife to create Forrest grade Ia or Ib bleeding. The hemostatic powder was then applied until hemostasis was achieved.

Results

Initial hemostasis was achieved in all animals. Results of pre- and post-treatment coagulation studies were similar. All animals survived at least 9 days post-procedure. The hemostatic powder was not found in any local, regional, or systemic tissues. Gross and histologic analysis of systemic organs showed no infarct, particulate, or embolic effects. No gross or microscopic necropsy findings were treatment-related.

Conclusions

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.

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Acknowledgment

The authors thank William Voorhees, PhD, of MED Institute, Inc. (a contract research organization and Cook Group Company) for critical manuscript review.

Conflict of interest

Dr. Samuel Giday is a consultant for Cook Medical. Drs. Van Alstine and Van Vleet are independent contractors for MED Institute, Inc (a Cook Group company), although Dr. Van Vleet passed away prior to manuscript submission. Richard Ducharme was a full-time employee of Cook Endoscopy (a Cook Group company) at the time of the study; he is currently employed elsewhere. The following authors are full-time employees of MED Institute, Inc: Eric Brandner, Madalina Florea, Krystal Johnston, Jose Negron-Garcia, and Kimberly Ringenberger. The study was funded by Cook Medical, the manufacturer of the hemostatic powder.

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Authors and Affiliations

  1. Center for Digestive Health, 1817 North Mills Avenue, Orlando, FL, 32803, USA

    Samuel Giday

  2. College of Veterinary Medicine, Purdue University, 625 Harrison Street, West Lafayette, IN, USA

    William Van Alstine & John Van Vleet

  3. Cook Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC, 27105, USA

    Richard Ducharme

  4. MED Institute, Incorporated, 1 Geddes Way, West Lafayette, IN, 47906, USA

    Eric Brandner, Madalina Florea, Krystal Johnston, Jose Negron-Garcia & Kimberly Ringenberger

Authors
  1. Samuel Giday
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  2. William Van Alstine
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  3. John Van Vleet
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  4. Richard Ducharme
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  5. Eric Brandner
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  6. Madalina Florea
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  7. Krystal Johnston
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  8. Jose Negron-Garcia
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  9. Kimberly Ringenberger
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Corresponding author

Correspondence to Samuel Giday.

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Giday, S., Van Alstine, W., Van Vleet, J. et al. Safety Analysis of a Hemostatic Powder in a Porcine Model of Acute Severe Gastric Bleeding. Dig Dis Sci 58, 3422–3428 (2013). https://doi.org/10.1007/s10620-013-2846-z

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  • DOI: https://doi.org/10.1007/s10620-013-2846-z

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