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

NCT03131336 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 169

Last updated 2018-02-27

No results posted yet for this study

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).

Conditions

Interventions

DRUG

PeproStat

solution for local application

DRUG

Saline

solution for local application

Sponsors & Collaborators

  • Haemostatix Ltd

    lead INDUSTRY

Principal Investigators

  • Paul Hayes · Addenbrookes NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-31
Primary Completion
2017-08-23
Completion
2017-10-11

Countries

  • Bosnia and Herzegovina
  • Croatia
  • Poland
  • Serbia
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03131336 on ClinicalTrials.gov