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

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.

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.

Study Overview

• Status: Unknown
• Conditions: C.Surgical Procedure; Cardiac; Haemorrhage.
• Intervention / Treatment: Device: 032-11; Device: Floseal (R)

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • East Yorkshire
    • Hull, East Yorkshire, United Kingdom, HU3 2JZ
      • Recruiting
      • Hull and East Yorkshire Hospitals NHS Trust
      • Principal Investigator: Mahmoud Loubani, FRCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 032-11; 032-11 topical haemostat.	Device: 032-11; Topical haemostat
ACTIVE_COMPARATOR: Floseal (R); Floseal(R) topical haemostat	Device: Floseal (R); Topical haemostat

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medtrade
• Collaborators: The Clinical Trial Company
• Investigators: Study Chair: Russell Millner, MD FRCS, Blackpool Victoria Hospital NHS trust

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (ANTICIPATED): October 1, 2015

Study Registration Dates

• First Submitted: June 13, 2013
• First Submitted That Met QC Criteria: June 13, 2013
• First Posted (ESTIMATE): June 17, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): April 7, 2015
• Last Update Submitted That Met QC Criteria: April 6, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: CT001