Safety and Performance of 032-11 Haemostat in Cardiac and... | NCT01879475

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

NCT01879475

Sponsor

Medtrade

Status

Unknown status

Last Update Posted

Apr 7, 2015Estimated

Enrollment

200Estimated

Phase

Not Applicable

Conditions

C.Surgical Procedure; Cardiac
Haemorrhage.

Interventions

032-11
Floseal (R)

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2013

Primary Completion Date

Oct 2015Estimated

Completion Date

Not provided

First Submitted Date

Jun 13, 2013

First Submission Date that Met QC Criteria

Jun 13, 2013

First Posted Date

Jun 17, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 6, 2015

Last Update Posted Date

Apr 7, 2015Estimated

Name	Class
The Clinical Trial Company	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
032-11	Experimental	032-11 topical haemostat.	Device: 032-11
Floseal (R)	Active Comparator	Floseal(R) topical haemostat	Device: Floseal (R)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
032-11	Device	Topical haemostat	032-11
Floseal (R)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Haemostasis success	Proportion of patients achieving haemostasis success following the first application of compression.	Intra-operative

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sara Farmer	Contact	+44 1270 500 019		saraandpete.farmer@virgin.net
June Gladman, PhD	Contact	+44 1270 500 019		june.gladman@medtrade.co.uk

Overall Officials

Name	Affiliation	Role
Russell Millner, MD FRCS	Blackpool Victoria Hospital NHS trust	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hull and East Yorkshire Hospitals NHS Trust	Recruiting	Hull	East Yorkshire	HU3 2JZ	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D006470	Hemorrhage

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided