A multi-centre proof of concept study to assess efficacy and safety of endoscopic hemostasis with combined activated Factors IIa, VIIa, IXa and Xa (Seraseal/Fastact ®) in patients with acute gastrointestinal bleeding

Introduction: Endoscopic treatment of severe gastrointestinal bleeding can be difficult and high technical expertise is required. A simple and effective method of endoscopic hemostasis would have a significant impact on treatment success. Aim of the study is to assess the efficacy and safety of endoscopic hemostasis with combined activated factors IIa/VIIa/IXa/Xa (Seraseal, Wortham Laboratories, USA). Methods: Patients with active gastrointestinal bleeding were included. 5 ml Seraseal was topically applied via a standard delivery catheter to the bleeding site. In group A, Seraseal was applied as intital method for hemostasis. The site was then observed for 5 minutes. If bleeding remained active, the institutional standard of care for hemostasis was applied. In group B, Seraseal was applied after an initial failure of the institutional standard method. If bleeding remained active, alternative methods of hemostasis were applied. After successful hemostasis, patients were monitored for signs of recurrent bleeding or adverse effects for 72 hours. Endoscopy was performed if rebleeding was suspected. Results: 36 patients (mean age 69 y, 26 men) were included. Bleeding was stopped with Seraseal as initial hemostatic procedure in 17 of 24 patients (71%). Institutional standard stopped bleeding in 5 of the remaining 7 patients, 2 patients had to undergo coiling and surgery for definite hemostasis. In group B 12 patients with unsuccessful initial endoscopic treatment approach (clip in 4, suprarenin injection in 2, fibrin glue, band ligation and argon plasma coagulation in 1, combination in 3), addition of Seraseal was able to definitely stop the bleeding in 9 out of 12 patients (75%), in the remaining 3 patients additional endoscopic methods stopped the bleeding. Nine patients received red packed blood cells. No recurrence of bleeding was noted. Conclusion: The topic application of Seraseal on the bleeding site might be a valuable alternative or addition to conventional endoscopic hemostatic strategies.