Endoscopy 2016; 48(04): 380-384
DOI: 10.1055/s-0034-1393312
Innovations and brief communications
© Georg Thieme Verlag KG Stuttgart · New York

Efficacy and safety of bovine activated factors IIa/VIIa/IXa/Xa in patients with active gastrointestinal bleeding: a proof of concept study

Arnulf Ferlitsch
1   Department of Internal Medicine III, Division of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria
,
Andreas Puspok
1   Department of Internal Medicine III, Division of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria
,
Simona Bota
1   Department of Internal Medicine III, Division of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria
,
Friedrich Wewalka
2   Internal Medicine IV, KH der Elisabethinen, Linz, Austria
,
Rainer Schoefl
2   Internal Medicine IV, KH der Elisabethinen, Linz, Austria
,
Eva Brownstone
3   Internal Medicine IV, KH Rudolfstiftung, Vienna, Austria
,
Christian Madl
3   Internal Medicine IV, KH Rudolfstiftung, Vienna, Austria
,
Henrike Lenzen
4   Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany
,
Tim O. Lankisch
4   Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany
,
Werner Dolak
1   Department of Internal Medicine III, Division of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria
,
Michael H. Trauner
1   Department of Internal Medicine III, Division of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria
,
Monika Ferlitsch
1   Department of Internal Medicine III, Division of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria
› Author Affiliations
Further Information

Publication History

submitted: 06 April 2015

accepted after revision: 30 August 2015

Publication Date:
12 November 2015 (online)

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Background and study aims: Endoscopic treatment of active gastrointestinal bleeding often remains difficult, and considerable technical expertise is required. Our aim was to assess the efficacy and safety of endoscopic hemostasis with a liquid combination of bovine activated factors IIa/VIIa/IXa/Xa (SeraSeal).

Methods: Patients with active gastrointestinal bleeding were prospectively included. In group A, 5 mL of bovine activated factors IIa/VIIa/IXa/Xa was topically applied via catheters to the bleeding site as initial hemostasis; group B received a similar application but as rescue therapy after failure of conventional endoscopic hemostasis.

Results: In group A, bleeding was stopped by the agent in 15 /22 patients (68 %) and by conventional endoscopic hemostasis in 5 of the other 7, with coiling and surgery required for definitive hemostasis in 2. In group B, the addition of the agent definitively stopped bleeding in 13 /15 patients (87 %), with hemostasis in the remaining 2 achieved with fibrin glue. Rebleeding was observed in 1 patient.

Conclusions: Our proof of concept study suggests that the use of bovine activated factors IIa/VIIa/IXa/Xa might be a safe and effective addition to current endoscopic hemostatic strategies, but further studies are necessary.

ClinicalTrials.gov identifier: NCT02349490