Bleeding Clinical Trial
Official title:
A Controlled, Randomized, Multi-centre, Double Blind, Phase II Study to Evaluate Efficacy and Safety of Topical PeproStat in Intraoperative Surgical Haemostasis
The purpose of this study is to test the effectiveness and safety of a new peptide-based coagulant, PeproStat. The study drug will be applied to patients undergoing liver/soft tissue surgery, vascular surgery or spine surgery. The speed of action of the new coagulant, that is applied with a gelatin sponge, will be compared to the same sponge but with saline (a commonly used standard of care).
PeproStat is a new class of topical haemostatic agent composed of recombinant human albumin
(rHA) conjugated with fibrinogen-binding peptides. The conjugate polymerises fibrinogen into
a fibrin-like clot without the need for thrombin.
PeproStat is formulated in a liquid, and is soaked into a haemostatic gelatin sponge in the
operating theatre, and applied directly to the site of bleeding. The gelatin sponge
(Spongostan ) is an approved "passive" haemostat i.e., PeproStat is an adjunct to a passive
haemostat.
The study is designed in a 2:1 randomization (verum:placebo) to investigate the efficacy in
terms of Time to hemostasis, mean (mTTH) at the primary target bleed site (TBS), measured in
minutes (min) from the start of treatment application (TxStart) at the TBS to the achievement
of hemostasis at that site or to the end of the 10-minute assessment period if hemostasis has
not yet been achieved.
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