MedTrace Logo

Safety and Performance of 032-11 Haemostat in Cardiac and Thoracic Aortic Surgery

NCT01879475 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2015-04-07

No results posted yet for this study

Summary

The effectiveness objective of this study is to evaluate whether 032-11 is non-inferior to Floseal as an adjunct to achieving haemostasis during surgical procedures involving cardiac and aortic thoracic surgery.

Conditions

  • C.Surgical Procedure; Cardiac
  • Haemorrhage.

Interventions

DEVICE

032-11

Topical haemostat

DEVICE

Floseal (R)

Topical haemostat

Sponsors & Collaborators

  • The Clinical Trial Company

    collaborator INDUSTRY

  • Medtrade

    lead INDUSTRY

Principal Investigators

  • Russell Millner, MD FRCS · Blackpool Victoria Hospital NHS trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2015-10-31

Countries

  • United Kingdom

Study Locations

More Related Trials

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 NCT01879475 on ClinicalTrials.gov