NCT01879475

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 13, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 17, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Last Updated

April 7, 2015

Status Verified

April 1, 2015

Enrollment Period

2.3 years

First QC Date

June 13, 2013

Last Update Submit

April 6, 2015

Conditions

C.Surgical Procedure; CardiacHaemorrhage.

Outcome Measures

Primary Outcomes (1)

  • Haemostasis success

    Proportion of patients achieving haemostasis success following the first application of compression.

    Intra-operative

Study Arms (2)

032-11

EXPERIMENTAL

032-11 topical haemostat.

Device: 032-11

Floseal (R)

ACTIVE COMPARATOR

Floseal(R) topical haemostat

Device: Floseal (R)

Interventions

032-11DEVICE

Topical haemostat

032-11
Floseal (R)DEVICE

Topical haemostat

Floseal (R)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patient must be equal or greater than 18 years old
  • The patient must have elective or non-elective urgent cardiac surgery or thoracic aortic surgery
  • The patient must have no childbearing potential or have a negative serum or urine pregnancy test within 7 days of the planned surgery or in the opinion of the Investigator performs adequate contraception
  • The patient is willing and able to be contacted for the follow-up visit at 6- 8 weeks
  • The patient must provide written informed consent using a form that is reviewed and approved by the IEC

You may not qualify if:

  • The patient is currently enrolled in this or another investigational device or drug trial that has not completed the required follow up period.
  • The patient has a known hypersensitivity to materials of bovine origin
  • The patient does not wish to receive materials of bovine or shellfish origin for any reason

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hull and East Yorkshire Hospitals NHS Trust

Hull, East Yorkshire, HU3 2JZ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Russell Millner, MD FRCS

    Blackpool Victoria Hospital NHS trust

    STUDY CHAIR

Central Study Contacts

Sara Farmer

CONTACT

+44 1270 500 019saraandpete.farmer@virgin.net

June Gladman, PhD

CONTACT

+44 1270 500 019june.gladman@medtrade.co.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2013

First Posted

June 17, 2013

Study Start

June 1, 2013

Primary Completion

October 1, 2015

Last Updated

April 7, 2015

Record last verified: 2015-04

Locations

GB(1)