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. Giday, Y. Kim, D. M. Krishnamurty, R. Ducharme, D. B. Liang, Eun Shin, X. Dray, D. Hutcheon, K. Moskowitz, G. Donatelli, D. Rueben, Marcia Canto, P. I. Okolo, Anthony N Kalloo

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish (US)
Pages (from-to)296-299
Number of pages4
JournalEndoscopy
Volume43
Issue number4
DOIs
StatePublished - 2011

Fingerprint

Hemostatics
Swine
Randomized Controlled Trials
Hemorrhage
Hemostasis
Animal Models
Foreign-Body Granuloma
hemospray
Therapeutics
Laparotomy
Needles
Heparin
Stomach
Catheters
Placebos
Anti-Bacterial Agents
Safety
Pressure
Lung
Control Groups

ASJC Scopus subject areas

  • Gastroenterology

Cite this

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. / Giday, S. A.; Kim, Y.; Krishnamurty, D. M.; Ducharme, R.; Liang, D. B.; Shin, Eun; Dray, X.; Hutcheon, D.; Moskowitz, K.; Donatelli, G.; Rueben, D.; Canto, Marcia; Okolo, P. I.; Kalloo, Anthony N.

In: Endoscopy, Vol. 43, No. 4, 2011, p. 296-299.

Research output: Contribution to journalArticle

Giday, SA, Kim, Y, Krishnamurty, DM, Ducharme, R, Liang, DB, Shin, E, Dray, X, Hutcheon, D, Moskowitz, K, Donatelli, G, Rueben, D, Canto, M, Okolo, PI & Kalloo, AN 2011, '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', Endoscopy, vol. 43, no. 4, pp. 296-299. https://doi.org/10.1055/s-0030-1256125
Giday, S. A. ; Kim, Y. ; Krishnamurty, D. M. ; Ducharme, R. ; Liang, D. B. ; Shin, Eun ; Dray, X. ; Hutcheon, D. ; Moskowitz, K. ; Donatelli, G. ; Rueben, D. ; Canto, Marcia ; Okolo, P. I. ; Kalloo, Anthony N. / 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. In: Endoscopy. 2011 ; Vol. 43, No. 4. pp. 296-299.
@article{0626a740a9694d3eb8e0ca535b08128e,
title = "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",
abstract = "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.",
author = "Giday, {S. A.} and Y. Kim and Krishnamurty, {D. M.} and R. Ducharme and Liang, {D. B.} and Eun Shin and X. Dray and D. Hutcheon and K. Moskowitz and G. Donatelli and D. Rueben and Marcia Canto and Okolo, {P. I.} and Kalloo, {Anthony N}",
year = "2011",
doi = "10.1055/s-0030-1256125",
language = "English (US)",
volume = "43",
pages = "296--299",
journal = "Endoscopy",
issn = "0013-726X",
publisher = "Georg Thieme Verlag",
number = "4",

}

TY - JOUR

T1 - 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

AU - Giday, S. A.

AU - Kim, Y.

AU - Krishnamurty, D. M.

AU - Ducharme, R.

AU - Liang, D. B.

AU - Shin, Eun

AU - Dray, X.

AU - Hutcheon, D.

AU - Moskowitz, K.

AU - Donatelli, G.

AU - Rueben, D.

AU - Canto, Marcia

AU - Okolo, P. I.

AU - Kalloo, Anthony N

PY - 2011

Y1 - 2011

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=79953651939&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=79953651939&partnerID=8YFLogxK

U2 - 10.1055/s-0030-1256125

DO - 10.1055/s-0030-1256125

M3 - Article

C2 - 21384319

AN - SCOPUS:79953651939

VL - 43

SP - 296

EP - 299

JO - Endoscopy

JF - Endoscopy

SN - 0013-726X

IS - 4

ER -