Background and study aims: 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.
Patients and 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.
Conclusion: These pilot results indicate that Hemospray is safe in humans. Hemospray was effective
in achieving acute hemostasis in active peptic ulcer bleeding.
References
joesung@cuhk.edu.hk
