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Endoscopy 2011; 43(4): 296-299
DOI: 10.1055/s-0030-1256125
Original article

© Georg Thieme Verlag KG Stuttgart · New York

Long-term randomized controlled trial of a novel nanopowder hemostatic agent (TC-325) for control of severe arterial upper gastrointestinal bleeding in a porcine model

S.  A.  Giday1 , 2 , Y.  Kim1 , 3 , D.  M.  Krishnamurty1 , R.  Ducharme4 , D.  B.  Liang1 , E.  J.  Shin1 , X.  Dray1 , 5 , D.  Hutcheon1 , K.  Moskowitz4 , G.  Donatelli1 , D.  Rueben6 , M.  I.  Canto1 , P.  I.  Okolo1 , A.  N.  Kalloo1
  • 1Division of Gastroenterology and Hepatology, Johns Hopkins University School of Medicine, Johns Hopkins Hospital, Baltimore, USA
  • 2Department of Medicine, Division of Gastroenterology, Howard University College of Medicine, Washington DC, USA
  • 3Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea
  • 4Cook Endoscopy, Winston-Salem, North Carolina, USA
  • 5Department of Digestive Diseases, Lariboisière Hospital APHP and René Diderot-Paris 7 University, Paris, France
  • 6Department of Molecular and Comparative Pathobiology, Johns Hopkins University School of Medicine, Johns Hopkins Hospital, Baltimore, USA
Further Information

Publication History

submitted 21 August 2010

accepted after revision 3 November 2010

Publication Date:
07 March 2011 (online)

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Commentaire de travail de S. A. Giday et al., pp. 296Endoscopy 2011; 43(04): 462-462
DOI: 10.1055/s-0031-1291793

Background and study aim: Endoscopic therapy of brisk upper gastrointestinal bleeding remains challenging. A proprietary nanopowder (TC-325) has been proven to be effective in high pressure bleeding from external wounds. The efficacy and safety of TC-325 were assessed in a survival gastrointestinal bleeding animal model.

Method: 10 animals were randomized to treatment or sham. All animals received intravenous antibiotics, H2-blockers and heparin (activated clotting time 2 × normal). In a sterile laparotomy the gastroepiploic vessels were dissected, inserted through a 1-cm gastrotomy, and freely exposed in the gastric lumen, and the exposed vessel lacerated by needle knife. The treatment group received TC-325 by a modified delivery catheter while the sham group received no endoscopic treatment. Time to hemostasis, and mortality at 60 minutes, 24 hours, 48 hours, and 7 days were noted. Necropsy was performed in all animals.

Results: Spurting arterial bleeding was achieved in all animals. No control animal showed hemostasis within the first hour compared with 100 % (5 / 5) in the treatment arm (mean 13.8 minutes, P < 0.0079). Durable hemostasis was achieved with no evidence of rebleeding after 1 and 24 hours in 80 % (4 / 5) of the treated animals compared with none in the control group (P < 0.0098). None of the control animals survived more than 6 hours. Necropsy at 1 week in treated animals revealed healed gastrotomy without foreign body granuloma or embolization to the lung or brain.

Conclusion: TC-325 is safe and highly effective in achieving hemostasis in an anticoagulated severe arterial gastrointestinal bleeding animal model.

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S. A. GidayMD 

Johns Hopkins Hospital
Division of Gastroenterology

1830 East Monument Street, Room 424
Baltimore, MD 21205
USA

Fax: +1-410-614-2490

Email: sgiday1@jhmi.edu