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Trial registered on ANZCTR


Registration number
ACTRN12615001008516
Ethics application status
Approved
Date submitted
15/09/2015
Date registered
28/09/2015
Date last updated
8/01/2019
Date data sharing statement initially provided
8/01/2019
Date results information initially provided
8/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase 1 Study of a Novel Bi-Directional Arterial Cannula in Patients requiring Peripheral Cannulation for Cardiac Surgery.
Scientific title
A prospective, Phase 1, open treatment, non comparative, single centre, device study to evaluate the safety and performance of the MTMM bi-directional cannula in patients requiring peripheral cannulation for Cardiac Surgery.
Secondary ID [1] 287456 0
Nil known
Universal Trial Number (UTN)
U1111-1174-2732
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients who require peripheral cannulation for cardiac surgery. 296178 0
Condition category
Condition code
Cardiovascular 296456 296456 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The MTMM bi-directional cannula is a novel femoral arterial cannula that has been developed to improve standard retrograde perfusion without compromising distal limb flow during peripheral femoral cannulation for Cardiac Surgery.It is inserted on a single occasion by the cardiothoracic surgeon under direct vision into the femoral artery 5-10 minutes prior to institution of cardiopulmonary bypass (CPB). It remains in situ until approximately 15-30 minutes after the patient is taken off CPB. The patient may be on CPB for up to 240 minutes (but the most common duration is between 90-120 minutes).
Intervention code [1] 292833 0
Treatment: Devices
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296084 0
Safety - adverse events, adverse device events. The main potential risk is vessel damage requiring surgical repair. As the cannula is inserted under direct vision, if the vessel is injured it will be identified immediately and a surgical repair will be undertaken straight away. Dislogment of the cannula during CPB is a possible risk which could lead to blood loss. This would be identified immediately and would be rectified by repositioning the cannula under direct vision.
Timepoint [1] 296084 0
Measured fifteen minutely intraoperatively while in situ until the patient is taken off cardiopulmonary bypass and the cannula is removed.
Primary outcome [2] 296085 0
Performance of the cannula. Perfusion and blood flow to the lower limb of the cannulated leg, measured using Femoral Artery Doppler and Near Infrared Spectroscopy (NIRS)
Timepoint [2] 296085 0
Measured for the duration the cannula is in situ until cardiopulmonary bypass is no longer required and the cannula is removed.
Secondary outcome [1] 317459 0
Line pressure in bypass circuit which is directly measured from perfusion circuit.
Timepoint [1] 317459 0
Measured fifteen minutely while the cannula is in situ.
Secondary outcome [2] 317726 0
Blood flow through cannula also measured from the perfusion circuit.
Timepoint [2] 317726 0
Measured 15 minutely while the cannula is in situ.

Eligibility
Key inclusion criteria
1. Patients may be male or female
2. Patients must be 18 years or over and not more than 80 years of age.
3. Patients must be assessed as requiring cardiac surgery with cardiopulmonary bypass support by a cardio-thoracic surgeon.
4. Patients must weigh greater than 45kg and less than 130kg.
5. Site personnel must obtain informed consent from the patient prior to any study procedures (including screening procedures).
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients who have undergone previous vascular surgery of the femoral artery.
2. Patients requiring emergency cardiac surgery including Type A aortic dissections.
3. Patients where the internal diameter of the common femoral artery is not greater than 0.6cm.
4. Concurrent enrollment in another investigational drug or device study, or use of any experimental or investigational drug or device within 30 days of cardiopulmonary bypass support.
5. Any other medical condition which in the view if the Investigator is likely to interfere with the study or put the patient at risk.
6. Patients who the investigator feels will not achieve adequate flow rates and line pressures due to the patient's weight and body surface area.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This is a prospective non randomised open label trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Non randomised
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint(s)
Safety
Statistical methods / analysis
As this is a phase 1 study of 15 participants, no formal sample size calculations were conducted. Descriptive statistical analysis will be performed for all study endpoints. Given the exploratory nature of the study, additional analyses may be conducted.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 4339 0
The Alfred - Prahran
Recruitment postcode(s) [1] 10565 0
3181 - Prahran

Funding & Sponsors
Funding source category [1] 292044 0
Commercial sector/Industry
Name [1] 292044 0
MTMM Pty Ltd
Address [1] 292044 0
310 Glenferrie Rd
Malvern, VIC 3144
Australia
Country [1] 292044 0
Australia
Primary sponsor type
Hospital
Name
Alfred Hospital
Address
55 Commercial Rd
Melbourne
VIC 3004
Australia
Country
Australia
Secondary sponsor category [1] 290771 0
Individual
Name [1] 290771 0
Assoc Prof Silvana Marasco
Address [1] 290771 0
c/o Alfred Hospital
55 Commercial Rd
Melbourne
VIC 3004
Country [1] 290771 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293527 0
Alfred Health Human Ethics Committee
Ethics committee address [1] 293527 0
55 Commercial Rd
PO Box 315 Prahran
VIC 3181
Ethics committee country [1] 293527 0
Australia
Date submitted for ethics approval [1] 293527 0
22/01/2015
Approval date [1] 293527 0
04/08/2015
Ethics approval number [1] 293527 0
14/15

Summary
Brief summary
The aim of this study is to test a novel cannula that permits blood flow up and down the leg (called bi-directional) when placed in the femoral artery for the purposes of connecting patients to cardiopulmonary bypass during cardiac surgery.

As the cannula needs to be large to allow for a large volume of blood that must pass through the ECMO machine, the diameter of the cannula is almost the same as the diameter of the femoral artery so there is little room around the cannula for the blood to flow down the leg. Complications can arise due to poor blood flow down the leg which may result in irreversible damage to structures in the leg.

The use of a second downstream cannula or sewing a side graft are methods used to prevent complications from poor blood supply to the lower leg by providing a dedicated blood supply. These techniques are cumbersome, time consuming and require additional equipment. As a result current standard practice involves the use of an upstream femoral cannula only, relying on the very small amount of blood that will flow downstream around the cannula to keep the leg viable.

It is hoped that the use of the novel bi-directional femoral perfusion cannula in cardiac surgery will lead to an improvement in current practice by providing a more reliable continuous blood flow down the leg during cardiopulmonary bypass.

The aim of this study is to evaluate the safety and performance of the MTMM bi-directional cannula in the cardiac surgery setting and to determine whether this cannula provides adequate downstream blood flow to the limb to avoid complications from poor blood supply.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60246 0
A/Prof Silvana Marasco
Address 60246 0
Dept Cardiothoracic Surgery and Transplantation
Alfred Hospital
55 Commercial Rd
Prahran
VIC 3181
Country 60246 0
Australia
Phone 60246 0
+61 390768034
Fax 60246 0
Email 60246 0
s.marasco@alfred.org.au
Contact person for public queries
Name 60247 0
Ms Shirley Vallance
Address 60247 0
Dept Intensive Care Research
Alfred Hospital
55 Commercial Rd
Prahran
VIC 3181
Country 60247 0
Australia
Phone 60247 0
+61438220852
Fax 60247 0
Email 60247 0
s.vallance@alfred.org.au
Contact person for scientific queries
Name 60248 0
Ms Shirley Vallance
Address 60248 0
Dept Intensive Care Research
Alfred Hospital
55 Commercial Rd
Prahran
VIC 3181
Country 60248 0
Australia
Phone 60248 0
+61438220852
Fax 60248 0
Email 60248 0
s.vallance@alfred.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Journal publication details
Publication date and citation/details [1] 937 0
Innovations. Vol 13 March/April 2018 Vol 13 Number 2
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary
This trial demonstrates that the novel bi-directional cannula is safe and easy to insert in the femoral artery and provides stable blood flow down the leg during cardiopulmonary bypass.
The use of this device should largely remove the need to insert a separate cannula to provide blood flow down the leg, or use other techniques to protect against insufficient blood flow.