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

Endoscopy. 2016 Apr;48(4):380-4. doi: 10.1055/s-0034-1393312. Epub 2015 Nov 12.


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.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Video-Audio Media

MeSH terms

  • Administration, Intranasal
  • Aged
  • Animals
  • Calmodulin / administration & dosage*
  • Cattle
  • Cholangiopancreatography, Endoscopic Retrograde
  • Dose-Response Relationship, Drug
  • Drug Therapy, Combination
  • Factor IXa / administration & dosage*
  • Factor VIIa / administration & dosage*
  • Factor Xa / administration & dosage*
  • Female
  • Follow-Up Studies
  • Gastrointestinal Hemorrhage / diagnosis
  • Gastrointestinal Hemorrhage / drug therapy*
  • Hemostasis, Endoscopic / methods*
  • Humans
  • Male
  • Prospective Studies
  • Prothrombin / administration & dosage*
  • Time Factors
  • Treatment Outcome


  • Calmodulin
  • Prothrombin
  • Factor IIa
  • Factor VIIa
  • Factor IXa
  • Factor Xa

Associated data

  • ClinicalTrials.gov/NCT02349490