Hemospray® (hemostatic powder TC-325) as monotherapy for acute gastrointestinal bleeding: a multicenter prospective study

doi:10.20524/aog.2024.0897

. 2024 Jul-Aug;37(4):418-426.

doi: 10.20524/aog.2024.0897. Epub 2024 Jun 20.

Hemospray® (hemostatic powder TC-325) as monotherapy for acute gastrointestinal bleeding: a multicenter prospective study

Apostolis Papaefthymiou¹, Nasar Aslam², Mohamed Hussein^{3

4}, Durayd Alzoubaidi³, Seth A Gross⁵, Alvaro De La Serna⁶, Ioannis Varbobitis⁷, Tricia A Hengehold⁸, Miguel Fraile López⁹, Jacobo Ortiz Fernández-Sordo⁷, Johannes W Rey¹⁰, Bu Hayee¹¹, Edward J Despott¹², Alberto Murino^{1

12}, Sulleman Moreea¹³, Phil Boger¹⁴, Jason M Dunn¹⁵, Inder Mainie¹⁶, Daniel Mullady⁸, Dayna Early⁸, Melissa Latorre⁵, Krish Ragunath⁷, John T Anderson¹⁷, Pradeep Bhandari¹⁸, Martin Goetz¹⁹, Ralf Kiesslich²⁰, Emmanuel Coron²¹, Enrique Rodríguez De Santiago⁶, Tamas A Gonda²², Michael O'Donnell⁵, Benjamin Norton^{1

23}, Andrea Telese^{1

3}, Roberto Simons-Linares²⁴, Rehan Haidry^{1

2

3}

Affiliations

¹ Digestive Diseases and Surgery institute, Cleveland Clinic, London, UK (Apostolis Papaefthymiou, Alberto Murino, Benjamin Norton, Andrea Telese, Rehan Haidry).
² Department of Gastrointestinal Services, University College London Hospitals NHS Foundation Trust, London, UK (Nasar Aslam, Rehan Haidry).
³ Division of Surgery and Interventional Sciences, University College London, UK (Mohamed Hussein, Durayd Alzoubaidi, Andrea Telese, Rehan Haidry).
⁴ Department of Gastroenterology and Hepatology, Guy's and St Thomas' NHS Foundation Trust, UK (Mohamed Hussein).
⁵ NYU Langone, New York, USA (Seth A. Gross, Melissa Latorre, Michael O'Donnell).
⁶ Department of Gastroenterology and Hepatology, Ramon y Cajal University Hospital, IRYCIS, CIBEREHD, University of Alcala, Madrid, Spain (Alvaro De La Serna, Enrique Rodríguez De Santiago).
⁷ NIHR Nottingham Digestive Diseases Biomedical Research Centre, Nottingham University Hospitals, Nottingham, UK (Ioannis Varbobitis, Jacobo Ortiz Fernández-Sordo, Krish Ragunath).
⁸ Department of Gastroenterology, Washington University School of Medicine in St. Louis, St. Louis, Missouri, USA (Tricia A. Hengehold, Daniel Mullady, Dayna Early).
⁹ Gastroenterology and Hepatology Department, Clinical and Translational Research in Digestive Diseases, Valdecilla Research Institute (IDIVAL), Marqués de Valdecilla University Hospital, Santander, Spain (Miguel Fraile López).
¹⁰ Department of Gastroenterology, Osnabrück Clinic, Osnabrück, Germany (Johannes W. Rey).
¹¹ Department of Gastroenterology, Kings College Hospital, London, UK (Bu Hayee).
¹² Royal Free Unit for Endoscopy and Centre for Gastroenterology, Royal Free NHS Foundation Trust, London, UK (Edward J. Despott, Alberto Murino).
¹³ Department of Gastroenterology, Bradford Teaching Hospitals Foundation Trust, Bradford, UK (Sulleman Moreea).
¹⁴ Department of Gastroenterology, University Hospital Southampton NHS Foundation Trust, Southampton, UK (Phil Boger).
¹⁵ Department of Gastroenterology, Guy's and St Thomas' Foundation Trust, London, UK (Jason M. Dunn).
¹⁶ Department of Gastroenterology, Belfast Health and Social Care Trust, Belfast, UK (Inder Mainie).
¹⁷ Department of Gastroenterology, Gloucestershire Hospitals NHS Foundation Trust - Cheltenham General Hospital, Cheltenham, UK (John T. Anderson).
¹⁸ Department of Gastroenterology, Portsmouth Hospitals NHS Trust, Portsmouth, UK (Pradeep Bhandari).
¹⁹ Sindelfingen-Böblingen Clinic, Böblingen, Germany (Martin Goetz).
²⁰ Horst Schmidt Clinics, Wiesbaden, Germany (Ralf Kiesslich).
²¹ Department of Gastroenterology, University Hospital Center, Nantes, France (Emmanuel Coron).
²² Columbia University Medical Centre, New York, USA (Tamas A. Gonda).
²³ Centre for Obesity Research, Department of Medicine, University College London, UK (Benjamin Norton).
²⁴ Gastroenterology and Hepatology Department, Digestive Disease Institute, Cleveland Clinic, Cleveland, OH, USA (Roberto Simons-Linares).

PMID: 38974074
PMCID: PMC11226744
DOI: 10.20524/aog.2024.0897

Hemospray® (hemostatic powder TC-325) as monotherapy for acute gastrointestinal bleeding: a multicenter prospective study

Apostolis Papaefthymiou et al. Ann Gastroenterol. 2024 Jul-Aug.

. 2024 Jul-Aug;37(4):418-426.

doi: 10.20524/aog.2024.0897. Epub 2024 Jun 20.

Authors

Affiliations

¹ Digestive Diseases and Surgery institute, Cleveland Clinic, London, UK (Apostolis Papaefthymiou, Alberto Murino, Benjamin Norton, Andrea Telese, Rehan Haidry).
² Department of Gastrointestinal Services, University College London Hospitals NHS Foundation Trust, London, UK (Nasar Aslam, Rehan Haidry).
³ Division of Surgery and Interventional Sciences, University College London, UK (Mohamed Hussein, Durayd Alzoubaidi, Andrea Telese, Rehan Haidry).
⁴ Department of Gastroenterology and Hepatology, Guy's and St Thomas' NHS Foundation Trust, UK (Mohamed Hussein).
⁵ NYU Langone, New York, USA (Seth A. Gross, Melissa Latorre, Michael O'Donnell).
⁶ Department of Gastroenterology and Hepatology, Ramon y Cajal University Hospital, IRYCIS, CIBEREHD, University of Alcala, Madrid, Spain (Alvaro De La Serna, Enrique Rodríguez De Santiago).
⁷ NIHR Nottingham Digestive Diseases Biomedical Research Centre, Nottingham University Hospitals, Nottingham, UK (Ioannis Varbobitis, Jacobo Ortiz Fernández-Sordo, Krish Ragunath).
⁸ Department of Gastroenterology, Washington University School of Medicine in St. Louis, St. Louis, Missouri, USA (Tricia A. Hengehold, Daniel Mullady, Dayna Early).
⁹ Gastroenterology and Hepatology Department, Clinical and Translational Research in Digestive Diseases, Valdecilla Research Institute (IDIVAL), Marqués de Valdecilla University Hospital, Santander, Spain (Miguel Fraile López).
¹⁰ Department of Gastroenterology, Osnabrück Clinic, Osnabrück, Germany (Johannes W. Rey).
¹¹ Department of Gastroenterology, Kings College Hospital, London, UK (Bu Hayee).
¹² Royal Free Unit for Endoscopy and Centre for Gastroenterology, Royal Free NHS Foundation Trust, London, UK (Edward J. Despott, Alberto Murino).
¹³ Department of Gastroenterology, Bradford Teaching Hospitals Foundation Trust, Bradford, UK (Sulleman Moreea).
¹⁴ Department of Gastroenterology, University Hospital Southampton NHS Foundation Trust, Southampton, UK (Phil Boger).
¹⁵ Department of Gastroenterology, Guy's and St Thomas' Foundation Trust, London, UK (Jason M. Dunn).
¹⁶ Department of Gastroenterology, Belfast Health and Social Care Trust, Belfast, UK (Inder Mainie).
¹⁷ Department of Gastroenterology, Gloucestershire Hospitals NHS Foundation Trust - Cheltenham General Hospital, Cheltenham, UK (John T. Anderson).
¹⁸ Department of Gastroenterology, Portsmouth Hospitals NHS Trust, Portsmouth, UK (Pradeep Bhandari).
¹⁹ Sindelfingen-Böblingen Clinic, Böblingen, Germany (Martin Goetz).
²⁰ Horst Schmidt Clinics, Wiesbaden, Germany (Ralf Kiesslich).
²¹ Department of Gastroenterology, University Hospital Center, Nantes, France (Emmanuel Coron).
²² Columbia University Medical Centre, New York, USA (Tamas A. Gonda).
²³ Centre for Obesity Research, Department of Medicine, University College London, UK (Benjamin Norton).
²⁴ Gastroenterology and Hepatology Department, Digestive Disease Institute, Cleveland Clinic, Cleveland, OH, USA (Roberto Simons-Linares).

PMID: 38974074
PMCID: PMC11226744
DOI: 10.20524/aog.2024.0897

Abstract

Background: Hemostatic powders are used as second-line treatment in acute gastrointestinal (GI) bleeding (AGIB). Increasing evidence supports the use of TC-325 as monotherapy in specific scenarios. This prospective, multicenter study evaluated the performance of TC-325 as monotherapy for AGIB.

Methods: Eighteen centers across Europe and USA contributed to a registry between 2016 and 2022. Adults with AGIB were eligible, unless TC-325 was part of combined hemostasis. The primary endpoint was immediate hemostasis. Secondary outcomes were rebleeding and mortality. Associations with risk factors were investigated (statistical significance at P≤0.05).

Results: One hundred ninety patients were included (age 51-81 years, male: female 2:1), with peptic ulcer (n=48), upper GI malignancy (n=79), post-endoscopic treatment hemorrhage (n=37), and lower GI lesions (n=26). The primary outcome was recorded in 96.3% (95% confidence interval [CI]: 92.6-98.5) with rebleeding in 17.4% (95%CI 11.9-24.1); 9.9% (95%CI 5.8-15.6) died within 7 days, and 21.7% (95%CI 15.6-28.9) within 30 days. Regarding peptic ulcer, immediate hemostasis was achieved in 88% (95%CI 75-95), while 26% (95%CI 13-43) rebled. Higher ASA score was associated with mortality (OR 23.5, 95%CI 1.60-345; P=0.02). Immediate hemostasis was achieved in 100% of cases with malignancy and post-intervention bleeding, with rebleeding in 17% and 3.1%, respectively. Twenty-six patients received TC-325 for lower GI bleeding, and in all but one the primary outcome was achieved.

Conclusions: TC-325 monotherapy is safe and effective, especially in malignancy or post-endoscopic intervention bleeding. In patients with peptic ulcer, it could be helpful when the primary treatment is unfeasible, as bridge to definite therapy.

Keywords: Hemospray®; TC-325; endoscopy; upper gastrointestinal bleeding.

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Conflict of interest statement

Conflict of Interest: Rehan J. Haidry declares: Pentax Medical, Apollo Endosurgery, Medtronic, Odin Vision, Cook Endoscopy, Fractyl Limited, Endogastric Solutions; Enrique Rodríguez de Santiago declares: Olympus, Norgine and Apollo Endosurgery (Educational activities) Adacyte therapeuthics (Advisory); Seth A. Gross declares: Cook, Medtronic, Olympus, Microtech. The other authors have nothing to declare

Figures

**Figure 1**
The Hemospray^® (TC-325) device

**Figure 2**
Bleeding peptic ulcer (Forrest Ib) (A), with TC-325 application (B) and immediate hemostasis (C)

**Figure 3**
Causes of gastrointestinal bleeding post-endoscopic intervention ESD, endoscopic submucosal dissection; EMR, endoscopic mucosal resection

**Figure 4**
Proposed algorithm for Hemospray® use in gastrointestinal (GI) bleeding

See this image and copyright information in PMC

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References

1. Kawanami S, Egami Y, Sugae H, et al. Predictors of bleeding events in acute decompensated heart failure patients with antithrombotic therapy:AURORA study. ESC Heart Fail. 2023;10:1114–1121. - PMC - PubMed
1. Moudallel S, van den Eynde C, Malý J, Rydant S, Steurbaut S. Retrospective analysis of gastrointestinal bleedings with direct oral anticoagulants reported to EudraVigilance. Naunyn Schmiedebergs Arch Pharmacol. 2023;396:1143–1153. - PubMed
1. Oakland K. Changing epidemiology and etiology of upper and lower gastrointestinal bleeding. Best Pract Res Clin Gastroenterol. 2019;42-43:101610. - PubMed
1. Wuerth BA, Rockey DC. Changing epidemiology of upper gastrointestinal hemorrhage in the last decade:a nationwide analysis. Dig Dis Sci. 2018;63:1286–1293. - PubMed
1. Button LA, Roberts SE, Evans PA, et al. Hospitalized incidence and case fatality for upper gastrointestinal bleeding from 1999 to 2007:a record linkage study. Aliment Pharmacol Ther. 2011;33:64–76. - PubMed

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[1] Kawanami S, Egami Y, Sugae H, et al. Predictors of bleeding events in acute decompensated heart failure patients with antithrombotic therapy:AURORA study. ESC Heart Fail. 2023;10:1114–1121. - PMC - PubMed

[2] Kawanami S, Egami Y, Sugae H, et al. Predictors of bleeding events in acute decompensated heart failure patients with antithrombotic therapy:AURORA study. ESC Heart Fail. 2023;10:1114–1121. - PMC - PubMed

[3] Moudallel S, van den Eynde C, Malý J, Rydant S, Steurbaut S. Retrospective analysis of gastrointestinal bleedings with direct oral anticoagulants reported to EudraVigilance. Naunyn Schmiedebergs Arch Pharmacol. 2023;396:1143–1153. - PubMed

[4] Moudallel S, van den Eynde C, Malý J, Rydant S, Steurbaut S. Retrospective analysis of gastrointestinal bleedings with direct oral anticoagulants reported to EudraVigilance. Naunyn Schmiedebergs Arch Pharmacol. 2023;396:1143–1153. - PubMed

[5] Oakland K. Changing epidemiology and etiology of upper and lower gastrointestinal bleeding. Best Pract Res Clin Gastroenterol. 2019;42-43:101610. - PubMed

[6] Oakland K. Changing epidemiology and etiology of upper and lower gastrointestinal bleeding. Best Pract Res Clin Gastroenterol. 2019;42-43:101610. - PubMed

[7] Wuerth BA, Rockey DC. Changing epidemiology of upper gastrointestinal hemorrhage in the last decade:a nationwide analysis. Dig Dis Sci. 2018;63:1286–1293. - PubMed

[8] Wuerth BA, Rockey DC. Changing epidemiology of upper gastrointestinal hemorrhage in the last decade:a nationwide analysis. Dig Dis Sci. 2018;63:1286–1293. - PubMed

[9] Button LA, Roberts SE, Evans PA, et al. Hospitalized incidence and case fatality for upper gastrointestinal bleeding from 1999 to 2007:a record linkage study. Aliment Pharmacol Ther. 2011;33:64–76. - PubMed

[10] Button LA, Roberts SE, Evans PA, et al. Hospitalized incidence and case fatality for upper gastrointestinal bleeding from 1999 to 2007:a record linkage study. Aliment Pharmacol Ther. 2011;33:64–76. - PubMed

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Hemospray® (hemostatic powder TC-325) as monotherapy for acute gastrointestinal bleeding: a multicenter prospective study

Affiliations

Hemospray® (hemostatic powder TC-325) as monotherapy for acute gastrointestinal bleeding: a multicenter prospective study

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Affiliations

Abstract

Conflict of interest statement

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