ANZCTR - Registration

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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 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]

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.

Condition category

Condition code

Cardiovascular

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]

Treatment: Devices

Comparator / control treatment

Nil

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

Measured fifteen minutely intraoperatively while in situ until the patient is taken off cardiopulmonary bypass and the cannula is removed.

Primary outcome [2]

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]

Measured for the duration the cannula is in situ until cardiopulmonary bypass is no longer required and the cannula is removed.

Secondary outcome [1]

Line pressure in bypass circuit which is directly measured from perfusion circuit.

Timepoint [1]

Measured fifteen minutely while the cannula is in situ.

Secondary outcome [2]

Blood flow through cannula also measured from the perfusion circuit.

Timepoint [2]

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

Sex

Both males and females

Can healthy volunteers participate?

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

20/05/2016

Actual

16/08/2016

Date of last participant enrolment

Anticipated

17/10/2016

Actual

10/05/2017

Date of last data collection

Anticipated

Actual

7/07/2017

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

The Alfred - Prahran

Recruitment postcode(s) [1]

3181 - Prahran

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

MTMM Pty Ltd

Address [1]

310 Glenferrie Rd
Malvern, VIC 3144
Australia

Country [1]

Australia

Primary sponsor type

Hospital

Name

Alfred Hospital

Address

55 Commercial Rd
Melbourne
VIC 3004
Australia

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Assoc Prof Silvana Marasco

Address [1]

c/o Alfred Hospital
55 Commercial Rd
Melbourne
VIC 3004

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Alfred Health Human Ethics Committee

Ethics committee address [1]

55 Commercial Rd
PO Box 315 Prahran
VIC 3181

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

22/01/2015

Approval date [1]

04/08/2015

Ethics approval number [1]

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

A/Prof Silvana Marasco

Address

Dept Cardiothoracic Surgery and Transplantation
Alfred Hospital
55 Commercial Rd
Prahran
VIC 3181

Country

Australia

Phone

+61 390768034

Fax

s.marasco@alfred.org.au

Contact person for public queries

Name

Shirley Vallance

Address

Dept Intensive Care Research
Alfred Hospital
55 Commercial Rd
Prahran
VIC 3181

Country

Australia

Phone

+61438220852

Fax

s.vallance@alfred.org.au

Contact person for scientific queries

Name

Shirley Vallance

Address

Dept Intensive Care Research
Alfred Hospital
55 Commercial Rd
Prahran
VIC 3181

Country

Australia

Phone

+61438220852

Fax

s.vallance@alfred.org.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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