title: Efficacy and safety of bovine activated factors IIa/VIIa/IXa/Xa in patients with active gastrointestinal bleeding: a proof of concept study.
abstract: OBJECTIVE
  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.
authors.affiliation: Department of Internal Medicine III, Division of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria.
authors.forename: Arnulf
authors.initials: A
authors.lastname: Ferlitsch
authors.affiliation: Department of Internal Medicine III, Division of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria.
authors.forename: Andreas
authors.initials: A
authors.lastname: Puspok
authors.affiliation: Department of Internal Medicine III, Division of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria.
authors.forename: Simona
authors.initials: S
authors.lastname: Bota
authors.affiliation: Internal Medicine IV, KH der Elisabethinen, Linz, Austria.
authors.forename: Friedrich
authors.initials: F
authors.lastname: Wewalka
authors.affiliation: Internal Medicine IV, KH der Elisabethinen, Linz, Austria.
authors.forename: Rainer
authors.initials: R
authors.lastname: Schoefl
authors.affiliation: Internal Medicine IV, KH Rudolfstiftung, Vienna, Austria.
authors.forename: Eva
authors.initials: E
authors.lastname: Brownstone
authors.affiliation: Internal Medicine IV, KH Rudolfstiftung, Vienna, Austria.
authors.forename: Christian
authors.initials: C
authors.lastname: Madl
authors.affiliation: Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.
authors.forename: Henrike
authors.initials: H
authors.lastname: Lenzen
authors.affiliation: Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.
authors.forename: Tim O
authors.initials: TO
authors.lastname: Lankisch
authors.affiliation: Department of Internal Medicine III, Division of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria.
authors.forename: Werner
authors.initials: W
authors.lastname: Dolak
authors.affiliation: Department of Internal Medicine III, Division of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria.
authors.forename: Michael H
authors.initials: MH
authors.lastname: Trauner
authors.affiliation: Department of Internal Medicine III, Division of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria.
authors.forename: Monika
authors.initials: M
authors.lastname: Ferlitsch
mesh_terms: D000281:Administration, Intranasal; D000368:Aged; D000818:Animals; D002147:Calmodulin / Q000008:administration & dosage*; D002417:Cattle; D002760:Cholangiopancreatography, Endoscopic Retrograde; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D015949:Factor IXa / Q000008:administration & dosage*; D015942:Factor VIIa / Q000008:administration & dosage*; D015951:Factor Xa / Q000008:administration & dosage*; D005260:Female; D005500:Follow-Up Studies; D006471:Gastrointestinal Hemorrhage / Q000175:diagnosis / Q000188:drug therapy*; D016558:Hemostasis, Endoscopic / Q000379:methods*; D006801:Humans; D008297:Male; D011446:Prospective Studies; D011516:Prothrombin / Q000008:administration & dosage*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002147:Calmodulin; D011516:Prothrombin; C025337:Factor IIa; D015942:Factor VIIa; D015949:Factor IXa; D015951:Factor Xa