Heart SurgeryNCT03717649
Negative Venous Line Pressure in a Miniaturised Cardiopulmonary Bypass Circuit (CPB)
A study testing Conventional 2-stage venous cannula, Conventional 3-stage venous cannula and Fenestrated 3-stage venous cannula in people with Heart Surgery, run by University Hospital Plymouth NHS Trust.
Trial summary
Study to measure the ability of a 'fenestrated' venous line cannula to reduce the negative line pressure seen with kinetic-assist active venous drainage (KAVD) in a standard miniaturised cardiopulmonary bypass circuit and thereby increase the flow characteristics of the bypass pump. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Surgery
- What is being tested?
- Conventional 2-stage venous cannula, Conventional 3-stage venous cannula and Fenestrated 3-stage venous cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 12 Jan 2016to 31 Oct 2016
- 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
- All patients over the age of 18 years of age scheduled to undergo isolated Coronary Artery Bypass Grafting (CABG) or isolated Aortic Valve Replacement (AVR), who are able and willing to consent.
- Consultant surgeon willing to operate using either Mini-CPB for CABG or AVR surgery.
Who cannot join
- Re-operation and emergency surgery
- Patients refusing or unable to provide informed consent
About this study
Official title: Negative Venous Line Pressure in a Miniaturised Cardiopulmonary Bypass Circuit - the Influence of a Fenestrated Venous Cannula and Its Effect on Pump Flow
Study to measure the ability of a 'fenestrated' venous line cannula to reduce the negative line pressure seen with kinetic-assist active venous drainage (KAVD) in a standard miniaturised cardiopulmonary bypass circuit and thereby increase the flow characteristics of the bypass pump.
Read the detailed description
To investigate whether a new venous drainage pipe (cannula) which has three sets of drainage holes (three-stage) compared with the standard two-stage cannula, or a three-stage which also has additional windows (fenestrations), can improve the drainage of blood into the circuit, reducing the negative pressure produced and increase the blood flow delivered to the patient. Patients who consent to participate will be randomly assigned to one of three types of venous cannula:
- Standard venous cannulation with a two-stage venous cannula
- The three-stage cannula (91437C, Medtronic)
- The fenestrated three-stage cannula (MC2X, Medtronic)
- Conditions
- Heart Surgery
- Being tested
- Conventional 2-stage venous cannula, Conventional 3-stage venous cannula, Fenestrated 3-stage venous cannula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional 2-stage venous cannulaDevice
venous cannula
Conventional 3-stage venous cannulaDevice
venous cannula
Fenestrated 3-stage venous cannulaDevice
venous cannula
| Study group | Role | What they receive |
|---|---|---|
| Conventional 2-stage venous cannulation | Active comparator | The two-stage venous cannula 36Fr and 51Fr (size) for each of the two stages (91251C, Medtronic) Receives: Device: Conventional 2-stage venous cannula |
| Conventional 3-stage venous cannula | Active comparator | The standard three-stage cannula (91437C, Medtronic) is 29Fr, 46Fr and 37Fr for each of the three stages. Receives: Device: Conventional 3-stage venous cannula |
| Fenestrated 3-stage venous cannula | Experimental | The fenestrated three-stage cannula (MC2X, Medtronic) is 29Fr, 29Fr and 29Fr for each of the three stages. Receives: Device: Fenestrated 3-stage venous cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average blood flow
Average blood flow measured in litres per minute per body surface area meter (squared).
Measured: duration of surgery
Secondary outcomes (4)
Negative pressure readings
The duration and depth of negative pressure readings from the venous line during cardiopulmonary bypass (CPB) are made in negative pressure readings in mmHg.
Measured: duration of surgery
Number of microbubbles
Measured as total count (n).
Measured: duration of surgery
Size of microbubbles
Measured as total volume (ml).
Measured: duration of surgery
Haemolysis
Differences in the rate of haemolysis associated with the cannula is measured by the relative increase in plasma alanine aminotransferase (ALT) concentration U/l, as a percentage change from baseline at each of 3 later timepoints.
Measured: duration of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study start12 Jan 2016
- Primary completion31 Oct 2016
- Study completion31 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart SurgeryStudies 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
- Sequential
- Model description
- A single centre, prospective, randomised, double-blind trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Plymouth NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Bennett, MD, Principal investigator, University Hospital Plymouth NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03717649
- Sponsor's protocol ID
- 15/P/003
- Status last verified
- Oct 2018
- First submitted
- 5 Oct 2018
- Last updated
- 24 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No current plan to share data, but would consider if approached.
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Negative Venous Line Pressure in a Miniaturised Cardiopulmonary Bypass Circuit - the Influence of a Fenestrated Venous Cannula and Its Effect on Pump Flow
- ClinicalTrials.gov ID
- NCT03717649
- Acronym / sponsor ID
- 15/P/003
- Conditions
- Heart Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University Hospital Plymouth NHS TrustUniversity, hospital or other
- Study start
- 12 Jan 2016 (actual)
- Primary completion
- 31 Oct 2016 (actual)
- Study completion
- 31 Oct 2016 (actual)
- First posted
- 24 Oct 2018 (actual)
- 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.
Study to measure the ability of a 'fenestrated' venous line cannula to reduce the negative line pressure seen with kinetic-assist active venous drainage (KAVD) in a standard miniaturised cardiopulmonary bypass circuit and thereby increase the flow characteristics of the bypass pump.
Detailed description
To investigate whether a new venous drainage pipe (cannula) which has three sets of drainage holes (three-stage) compared with the standard two-stage cannula, or a three-stage which also has additional windows (fenestrations), can improve the drainage of blood into the circuit, reducing the negative pressure produced and increase the blood flow delivered to the patient. Patients who consent to participate will be randomly assigned to one of three types of venous cannula:
- Standard venous cannulation with a two-stage venous cannula
- The three-stage cannula (91437C, Medtronic)
- The fenestrated three-stage cannula (MC2X, Medtronic)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- A single centre, prospective, randomised, double-blind trial
| Arm | Type | Receives |
|---|---|---|
| Conventional 2-stage venous cannulation | Active comparator | Device: Conventional 2-stage venous cannulaThe two-stage venous cannula 36Fr and 51Fr (size) for each of the two stages (91251C, Medtronic) |
| Conventional 3-stage venous cannula | Active comparator | Device: Conventional 3-stage venous cannulaThe standard three-stage cannula (91437C, Medtronic) is 29Fr, 46Fr and 37Fr for each of the three stages. |
| Fenestrated 3-stage venous cannula | Experimental | Device: Fenestrated 3-stage venous cannulaThe fenestrated three-stage cannula (MC2X, Medtronic) is 29Fr, 29Fr and 29Fr for each of the three stages. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients over the age of 18 years of age scheduled to undergo isolated Coronary Artery Bypass Grafting (CABG) or isolated Aortic Valve Replacement (AVR), who are able and willing to consent.
- Consultant surgeon willing to operate using either Mini-CPB for CABG or AVR surgery.
Key exclusion criteria (2 listed)
- Re-operation and emergency surgery
- Patients refusing or unable to provide informed consent
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 |
|---|---|---|
| Conventional 2-stage venous cannulavenous cannula | Device | Conventional 2-stage venous cannulation |
| Conventional 3-stage venous cannulavenous cannula | Device | Conventional 3-stage venous cannula |
| Fenestrated 3-stage venous cannulavenous cannula | Device | Fenestrated 3-stage venous cannula |
Primary outcome
Average blood flow
Time frame: duration of surgery
Average blood flow measured in litres per minute per body surface area meter (squared).
4 secondary outcomes
Negative pressure readings
Time frame: duration of surgery
Number of microbubbles
Time frame: duration of surgery
Size of microbubbles
Time frame: duration of surgery
Haemolysis
Time frame: duration of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2018.
- Individual participant dataSharing planned: No. No current plan to share data, but would consider if approached.
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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.
Mark Bennett, MD principal investigator
University Hospital Plymouth NHS Trust
Questions about this trial
What is this clinical trial studying?
A study testing Conventional 2-stage venous cannula, Conventional 3-stage venous cannula and Fenestrated 3-stage venous cannula in people with Heart Surgery, run by University Hospital Plymouth NHS Trust.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 24 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average blood flow (time frame: duration of surgery). 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 24 Oct 2018.