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A solution of PeproStat containing up to 9.25mg protein soaked immediately prior to use onto a Gelita-Spon® gelatin sponge.

PeproStat

D Mirza, MBBS, MS, FRCS

The purpose of this First in Man study is to evaluate the safety and tolerability, as well as to explore efficacy of PeproStat, a new peptide based coagulant (haemostat), when used in patients undergoing open liver resection surgery.

PeproStat Haemostat Study in Subjects Undergoing Liver Surgery

A Multi-centre, Open-label, Uncontrolled, First-in-Human Study to Evaluate the Safety and Tolerability and Explore the Efficacy of PeproStat in Gelita-Spon® Gelatin Sponge in Subjects Undergoing Open Liver Resection Surgery

Immunogenicity to be investigated using a specific antibody test which has been established but not yet validated.

Incidence, severity, and relatedness of adverse events (AEs) and adverse drug reactions (ADRs).

Percentages of subjects who achieve haemostasis within 3, 5, 7 and 10 minutes following application for the first five subjects and at 1, 3, 5, 7 \& 10 minutes following application in subsequent subjects.

Percentage of subjects who do not achieve haemostasis within 10 minutes.

Administered dose of PeproStat determined by number of sponges administered to a single bleeding site.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
PeproStat Haemostat Study in Subjects Undergoing Liver Surgery	NCT02204930	Hemorrhage	PeproStat	18 Years -	Haemostatix Ltd
PeproStat Haemostat Study in Subjects Undergoing Liver Surgery	NCT02204930	Hemorrhage	PeproStat	18 Years -	Haemostatix Ltd

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