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

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).


Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, interventional, randomized, controlled, double-blind, parallel group
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Controlled, Randomized, Multi-centre, Double Blind, Phase II Study to Evaluate Efficacy and Safety of Topical PeproStat in Intraoperative Surgical Haemostasis
Estimated Enrollment: 240
Actual Study Start Date: March 31, 2017
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)

Arms:
- Experimental: PeproStat
- Placebo Comparator: Saline