Background and Aims: The aim of this study was to evaluate the safety and effectiveness of Hemospray (Cook Medical, Winston-Salem, NC, USA), a hemostatic powder, as monotherapy for active peptic ulcer bleeding. Methods: In this prospective, multicenter, single-arm study, patients with Forrest Ia or Ib peptic ulcers underwent endoscopic application of Hemospray as treatment of first intent. Effectiveness endpoints were successful hemostasis at the end of the index endoscopy, recurrent bleeding within 72 hours and from 72 hours to 30 days, adverse events requiring reintervention or resulting in morbidity or mortality, and 30-day mortality. Results: Hemospray was successfully administered in 98.5% of patients (66/67). Hemostasis was achieved at the index endoscopy in 90.9% of patients (60/66) with Hemospray alone and in an additional 4 patients treated with additional modalities, yielding an overall hemostasis rate of 97.0% (64/66). Rebleeding occurred in 13.3% of patients (8/60), 5 within 72 hours and 3 between 72 hours and 30 days. Two cases of perforation and 2 patient deaths occurred during the study, but none of these cases or any other adverse events were attributed to the use of Hemospray. The rate of early rebleeding was significantly higher in patients with Forrest Ia ulcers compared with patients with Forrest Ib ulcers. Higher rates of early bleeding in patients with Forrest Ia ulcers is consistent with results from studies where Hemospray was used as rescue after failure of conventional methods. Conclusions: Hemospray is an effective initial treatment for patients with active peptic ulcer bleeding, but care should be taken to monitor for recurrent bleeding. (Clinical trial registration number: NCT01306864.)
|Early online date||2 Feb 2022|
|Publication status||Published - 1 Jul 2022|
Bibliographical noteFunding Information:
We thank Nicholas D. Dey, PhD, from Cook Research Incorporated for writing and editing assistance. DISCLOSURE: The following authors disclosed financial relationships: J. J. Y. Sung: Editor-in-Chief of the Journal of Gastroenterology and Hepatology. K. Ragunath: Educational and research grants from Cook Medical; associate editor for Digestive Endoscopy Journal. D. Wagner: Employee of Cook Medical. K. Sanborn: Employee of Cook Research Incorporated and Cook Group Company. All other authors disclosed no financial relationships. Research support for this study was provided by Cook Medical.
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