C.Surgical Procedure; CardiacNCT01879475
Safety and Performance of 032-11 Haemostat in Cardiac and Thoracic Aortic Surgery
A study testing 032-11 and Floseal (R) in people with C.Surgical Procedure; Cardiac and Haemorrhage., run by Medtrade at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- C.Surgical Procedure; Cardiac, Haemorrhage.
- What is being tested?
- 032-11 and Floseal (R)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2013to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Hull and East Yorkshire Hospitals NHS Trust
Hull, East Yorkshire, HU3 2JZ
Mahmoud Loubani, FRCS
About this study
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.
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.
- Being tested
- 032-11, Floseal (R)
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
032-11Device
Topical haemostat
Floseal (R)Device
Topical haemostat
| Study group | Role | What they receive |
|---|---|---|
| 032-11 | Experimental | 032-11 topical haemostat. Receives: Device: 032-11 |
| Floseal (R) | Active comparator | Floseal(R) topical haemostat Receives: Device: Floseal (R) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Haemostasis success
Proportion of patients achieving haemostasis success following the first application of compression.
Measured: Intra-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for C.Surgical Procedure; CardiacStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medtrade
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Clinical Trial Company
- Responsible party
- Sponsor
- Investigators
- Russell Millner, MD FRCS, Study chair, Blackpool Victoria Hospital NHS trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01879475
- Sponsor's protocol ID
- CT001
- Status last verified
- Apr 2015
- First submitted
- 13 Jun 2013
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01879475
- Acronym / sponsor ID
- CT001
- Conditions
- C.Surgical Procedure; Cardiac, Haemorrhage.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- MedtradeIndustry (pharma, biotech, devices)
- Collaborators
- The Clinical Trial Company
- Study start
- Jun 2013
- Primary completion
- Oct 2015 (estimated)
- First posted
- 17 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 032-11 | Experimental | Device: 032-11032-11 topical haemostat. |
| Floseal (R) | Active comparator | Device: Floseal (R)Floseal(R) topical haemostat |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 032-11Topical haemostat | Device | 032-11 |
| Floseal (R)Topical haemostat | Device | Floseal (R) |
Primary outcome
Haemostasis success
Time frame: Intra-operative
Proportion of patients achieving haemostasis success following the first application of compression.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
Related trials for C.Surgical Procedure; Cardiac
Active, not recruiting
Acute Normovolemic Hemodilution in High Risk Cardiac Surgery Patients.
C.Surgical Procedure; Cardiac
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Russell Millner, MD FRCS study chair
Blackpool Victoria Hospital NHS trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 032-11 and Floseal (R) in people with C.Surgical Procedure; Cardiac and Haemorrhage., run by Medtrade at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara Farmer (+44 1270 500 019, saraandpete.farmer@virgin.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Haemostasis success (time frame: Intra-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2015.