title: Early clinical experience of the safety and effectiveness of Hemospray in achieving hemostasis in patients with acute peptic ulcer bleeding.
abstract: OBJECTIVE
  Endoscopic therapy of upper gastrointestinal bleeding remains challenging with conventional endoscopic devices. Use of Hemospray, where a nanopowder with clotting abilities is sprayed onto the bleeding site, had been highly effective for management of arterial bleeding in a heparizined animal model. The safety and effectiveness of Hemospray for hemostasis of active peptic ulcer bleeding in humans was evaluated.
  
  
  METHODS
  In a prospective, single-arm, pilot clinical study, consecutive adults with confirmed peptic ulcer bleeding (Forrest score Ia or Ib), who had all given informed consent to participation, underwent upper gastrointestinal endoscopy and application of Hemospray within 24 hours of hospital admission once hemodynamically stable. Up to two applications of Hemospray, not exceeding a total of 150 g were allowed. Bleeding recurrence was monitored post procedurally, by second-look endoscopy (72 hours post treatment), and by phone at 30 days. Rate of hemostasis, recurrent bleeding, mortality, need for surgical intervention, and treatment-related complications were assessed.
  
  
  RESULTS
  20 patients were recruited (18 men, 2 women; mean age 60.2 years). Acute hemostasis was achieved in 95 % (19 / 20) of patients; 1 patient had a pseudoaneurysm requiring arterial embolization. Bleeding recurred in 2 patients within 72 hours (shown by hemoglobin drop); neither had active bleeding identified at the 72-hour endoscopy. No mortality, major adverse events, or treatment- or procedure-related serious adverse events were reported during 30-day follow-up.
  
  
  CONCLUSIONS
  These pilot results indicate that Hemospray is safe in humans. Hemospray was effective in achieving acute hemostasis in active peptic ulcer bleeding.
authors: Institute of Digestive Disease, The Chinese University of Hong Kong, Hong Kong. joesung@cuhk.edu.hk
authors: J J Y
authors: JJ
authors: Sung
authors: D
authors: D
authors: Luo
authors: J C Y
authors: JC
authors: Wu
authors: J Y L
authors: JY
authors: Ching
authors: F K L
authors: FK
authors: Chan
authors: J Y W
authors: JY
authors: Lau
authors: S
authors: S
authors: Mack
authors: R
authors: R
authors: Ducharme
authors: P
authors: P
authors: Okolo
authors: M
authors: M
authors: Canto
authors: A
authors: A
authors: Kalloo
authors: S A
authors: SA
authors: Giday
mesh_terms: D000208:Acute Disease; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D016558:Hemostasis, Endoscopic; D006490:Hemostatics / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D008875:Middle Aged; D053758:Nanoparticles; D010438:Peptic Ulcer Hemorrhage / Q000628:therapy*; D011208:Powders / Q000008:administration & dosage*
chemical_list: D006490:Hemostatics; D011208:Powders