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

Primary Purpose

C.Surgical Procedure; Cardiac, Haemorrhage.

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
032-11
Floseal (R)
Sponsored by
Medtrade
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for C.Surgical Procedure; Cardiac

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Hull and East Yorkshire Hospitals NHS TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

032-11

Floseal (R)

Arm Description

032-11 topical haemostat.

Floseal(R) topical haemostat

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 13, 2013
Last Updated
April 6, 2015
Sponsor
Medtrade
Collaborators
The Clinical Trial Company
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1. Study Identification

Unique Protocol Identification Number
NCT01879475
Brief Title
Safety and Performance of 032-11 Haemostat in Cardiac and Thoracic Aortic Surgery
Official Title
Prospective, Randomised, Controlled Investigation Comparing the Safety and Performance of 032-11 Surgical Haemostat With FLOSEAL® Haemostatic Matrix in Cardiac Surgery and Thoracic Aortic Surgery.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
October 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtrade
Collaborators
The Clinical Trial Company

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
C.Surgical Procedure; Cardiac, Haemorrhage.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
032-11
Arm Type
Experimental
Arm Description
032-11 topical haemostat.
Arm Title
Floseal (R)
Arm Type
Active Comparator
Arm Description
Floseal(R) topical haemostat
Intervention Type
Device
Intervention Name(s)
032-11
Intervention Description
Topical haemostat
Intervention Type
Device
Intervention Name(s)
Floseal (R)
Intervention Description
Topical haemostat
Primary Outcome Measure Information:
Title
Haemostasis success
Description
Proportion of patients achieving haemostasis success following the first application of compression.
Time Frame
Intra-operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Farmer
Phone
+44 1270 500 019
Email
saraandpete.farmer@virgin.net
First Name & Middle Initial & Last Name or Official Title & Degree
June Gladman, PhD
Phone
+44 1270 500 019
Email
june.gladman@medtrade.co.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Russell Millner, MD FRCS
Organizational Affiliation
Blackpool Victoria Hospital NHS trust
Official's Role
Study Chair
Facility Information:
Facility Name
Hull and East Yorkshire Hospitals NHS Trust
City
Hull
State/Province
East Yorkshire
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahmoud Loubani, FRCS

12. IPD Sharing Statement

Learn more about this trial

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

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