This site is intended for healthcare professionals
Clinical trials
  • Home
  • /
  • Clinical trials
  • /
  • Uncategorised Disease
  • /
  • PeproStat as a Topical Agent Used to Stop Bleeding...
Clinical trial

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

Read time: 3 mins
Last updated:31st Mar 2017
Identifier: NCT03131336

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)

- Experimental:
- Placebo Comparator: Saline

Category Value
Date last updated at source 2017-05-19
Study type(s) Interventional
Expected enrolment 240
Study start date 2017-03-31
Estimated primary completion date 2017-11-01

View full details