Outcomes of Hemospray therapy in the treatment of intraprocedural upper gastrointestinal bleeding post-endoscopic therapy

United European Gastroenterol J. 2020 Dec;8(10):1155-1162. doi: 10.1177/2050640620938549. Epub 2020 Jun 26.

Abstract

Introduction: With increasing advances in minimally invasive endoscopic therapies and endoscopic resection techniques for luminal disease, there is an increased risk of post-procedure bleeding. This can contribute to significant burden on patient's quality of life and health resources when reintervention is required. Hemospray (Cook Medical, North Carolina, USA) is a novel haemostatic powder licensed for gastrointestinal bleeding. The aim of this single-arm, prospective, non-randomised multicentre international study is to look at outcomes in patients with upper gastrointestinal bleeds following elective endoscopic therapy treated with Hemospray to achieve haemostasis.

Methods: Data was prospectively collected on the use of Hemospray from 16 centres (January 2016-November 2019). Hemospray was used during the presence of progressive intraprocedural bleeding post-endoscopic therapy as a monotherapy, dual therapy with standard haemostatic techniques or rescue therapy once standard methods had failed. Haemostasis was defined as the cessation of bleeding within 5 min of the application of Hemospray. Re-bleeding was defined as a sustained drop in haemoglobin (>2 g/l), haematemesis or melaena with haemodynamic instability after the index endoscopy.

Results: A total of 73 patients were analysed with bleeding post-endoscopic therapy. The median Blatchford score at baseline was five (interquartile range 0-9). The median Rockall score was six (interquartile range 5-7). Immediate haemostasis following the application of Hemospray was achieved in 73/73 (100%) of patients. Two out of 57 (4%) had a re-bleed post-Hemospray, one was following oesophageal endoscopic mucosal resection and the other post-duodenal endoscopic mucosal resection. Both patients had a repeat endoscopy and therapy within 24 h. Re-bleeding data was missing for 16 patients, and mortality data was missing for 14 patients. There were no adverse events recorded in association with the use of Hemospray.

Conclusion: Hemospray is safe and effective in achieving immediate haemostasis following uncontrolled and progressive intraprocedural blood loss post-endoscopic therapy, with a low re-bleed rate.

Keywords: Hemospray; TC-325; endoscopy; post-endotherapy bleeding; upper gastro-intestinal bleeding.

Publication types

  • Multicenter Study
  • Observational Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Blood Loss, Surgical / prevention & control*
  • Elective Surgical Procedures / adverse effects
  • Endoscopy, Gastrointestinal / adverse effects*
  • Endoscopy, Gastrointestinal / methods
  • Esophageal Mucosa / blood supply
  • Esophageal Mucosa / diagnostic imaging
  • Esophageal Mucosa / drug effects
  • Esophageal Mucosa / surgery
  • Female
  • Gastric Mucosa / blood supply
  • Gastric Mucosa / diagnostic imaging
  • Gastric Mucosa / drug effects
  • Gastric Mucosa / surgery
  • Gastrointestinal Hemorrhage / etiology
  • Gastrointestinal Hemorrhage / therapy*
  • Hemostasis, Endoscopic / methods*
  • Hemostatics / administration & dosage*
  • Humans
  • Intraoperative Care / methods
  • Male
  • Minerals / administration & dosage*
  • Prospective Studies
  • Recurrence
  • Treatment Outcome

Substances

  • Hemostatics
  • Minerals
  • hemospray