NCT03131336

PeproStat as a Topical Agent Used to Stop Bleeding in Patients Undergoing Surgery

A Controlled, Randomized, Multi-centre, Double Blind, Phase II Study to Evaluate Efficacy and Safety of Topical PeproStat in Intraoperative Surgical Haemostasis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 169 (actual)
• Sponsor: Haemostatix Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Bleeding

Interventions

Type	Name	Description
DRUG	PeproStat	solution for local application
DRUG	Saline	solution for local application

Timeline

• Start date: 2017-03-31
• Primary completion: 2017-08-23
• Completion: 2017-10-11
• First posted: 2017-04-27
• Last updated: 2018-02-27

Locations

5 sites across 5 countries: Bosnia and Herzegovina, Croatia, Poland, Serbia, United Kingdom