Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001086550
Ethics application status
Approved
Date submitted
23/01/2015
Date registered
15/10/2015
Date last updated
17/03/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A Prospective Phase 1 Study of a Novel Bi-Directional Arterial Cannula in Patients requiring Peripheral Veno-Arterial Extra Corporeal Membrane Oxygenation (VA-ECMO) Support.
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 undergoing VA-ECMO support.
Secondary ID [1] 286029 0
Nil Known
Universal Trial Number (UTN)
U1111-1166-3893
Trial acronym
The NIDA Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients who require peripheral cannulation for Veno-Arterial Extra Corporeal Membrane Oxygenation. 294011 0
Heart Failure 294471 0
Condition category
Condition code
Cardiovascular 294313 294313 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 femoral cannulation for Veno-Arterial Extra Corporeal Membrane Oxygenation (V-A ECMO) Support. It is inserted on a single occasion by the ICU ECMO consultant, into the femoral artery prior to institution of ECMO therapy. It remains in situ until ECMO is no longer required to support the patient.
Intervention code [1] 291022 0
Treatment: Devices
Comparator / control treatment
Nil.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294277 0
Safety - adverse events, adverse device events. The main potential risk may be the development of a thigh haematoma in the event the canula becomes displaced from the lumen of the artery while ECMO support is ongoing. The development of the haematoma may be rapid and extensive and may require surgical intervention
Timepoint [1] 294277 0
Patients and their cannula insertion site will be under constant observation for the duration of ECMO support. The average length of time expected for a patient to be on ECMO support is between 7 and 14 days but sometimes may be required for 21 days.
Primary outcome [2] 294279 0
Performance of the cannula indicated by perfusion and blood flow to the lower limb of the cannulated leg.
Timepoint [2] 294279 0
Perfusion and blood flow of the cannulated leg will be measured using Superficial Femoral Artery (SFA) Doppler and Near Infrared Spectroscopy (NIRS) within 1 hour of cannula insertion and thereafter daily until the cannula is removed.
Primary outcome [3] 294280 0
Plasma free haemoglobin will measure mechanical fragmentation of red blood cells.
Timepoint [3] 294280 0
Plasma free haemoglobin will be measured 6 hourly for the duration that the cannula is in situ.
Secondary outcome [1] 312936 0
Plasma Free Haemaoglobin to measure haemolysis
Timepoint [1] 312936 0
Measured Daily until the removal of the cannula.
Secondary outcome [2] 312937 0
ECMO circuit flow
Timepoint [2] 312937 0
1 hour post insertion and continuously - directly measured from the perfusion circuit. until ECMO support is no longer required.

Eligibility
Key inclusion criteria
1.Must be between18 years and 80 years inclusive.
2. Assessed as requiring V-A ECMO support by ICU consultant
3. Must weigh between 45kg and 130kg inclusive.
4. Site personel must obtain written informed consent from the patient or their legally authorised representative prior to any study procedures
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with a history of peripheral vascular disease
-previous peripheral arterial bypass
-diabetic vasculopathy
2. Patients with a history of diabetic retinopathy
3. Patients with a history of diabetic nephropathy
4. Patients where the common femoral artery is not identifiable with vascular ultrasound.
5. Patients where the common femoral artery is identifiable with vascular ultrasound but the internal diameter of the femoral artery is not greater than 0.6cm.
6.Patients requiring ECMO support to be instituted in the emergency setting during Cardio Pulmonary Resuscitation (CPR).
7. Non Alfred Hospital VA ECMO initiation (retrieval)
8. Concurrent enrolment in another investigational drug or device study, or use of any experimental or investigational drug or device within 30 days of ECMO support.
9. Any other medical condition which in the view of the investigator is likely to interfere with the study or put the participant at risk.
10. Patients who the investigator feels may not achieve adequate flow rates and line pressures due to their weight or body height.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This is a prospective non-randomised open label trial.
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
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2016
Actual
Date of last participant enrolment
Anticipated
1/06/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3362 0
The Alfred - Prahran
Recruitment postcode(s) [1] 9145 0
3181 - Prahran

Funding & Sponsors
Funding source category [1] 290630 0
Commercial sector/Industry
Name [1] 290630 0
MTMM Pty Ltd
Country [1] 290630 0
Australia
Primary sponsor type
Hospital
Name
The Alfred Hospital
Address
55 Commercial Rd
Melbourne
VIC 3004
Country
Australia
Secondary sponsor category [1] 289322 0
Individual
Name [1] 289322 0
Dr Vin Pellegrino
Address [1] 289322 0
c/o Alfred Hospital
55 Commercial Rd
Melbourne, VIC 3004
Country [1] 289322 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292261 0
Alfred Health Human Ethics Committee
Ethics committee address [1] 292261 0
55 Commercial Rd
PO Box 315 Prahran
Victoria3181
Australia
Ethics committee country [1] 292261 0
Australia
Date submitted for ethics approval [1] 292261 0
22/01/2015
Approval date [1] 292261 0
04/08/2015
Ethics approval number [1] 292261 0
10/15

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 the patient to Veno-Arterial Extracorporeal Membrane Oxygenation (V-A ECMO) support.

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.

To overcome this problem, a second cannula or downstream cannula is inserted to provide blood flow down the leg and less frequently a sidegraft to the femoral artery is performed. These techniques are time consuming and cumbersome and can delay the return of blood flow to the leg as the patient is placed on ECMO.

The novel bi-directional flow cannula is designed to provide blood flow up and down the leg so that a second downstream cannula is not needed. Blood flow in the leg will be measured while the cannula is in place, using non-invasive ultrasound and non-invasive near infra-red spectroscopy (NIRS) which is a simple, painless, non-invasive way of measuring oxygen in the blood in the leg.
Prior testing of the cannula in animal models proved safe and effective.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 54318 0
Dr Vincent Pellegrino
Address 54318 0
c/o Intensive Care Research
Alfred Hospital
Melbourne
VIC 3004
Country 54318 0
Australia
Phone 54318 0
+61 419770131
Fax 54318 0
Email 54318 0
[email protected]
Contact person for public queries
Name 54319 0
Ms Shirley Vallance
Address 54319 0
c/o Intensive Care Research
Alfred Hospital
PO Box 315
Prahran
VIC 3181
Australia
Country 54319 0
Australia
Phone 54319 0
+61 438220852
Fax 54319 0
Email 54319 0
[email protected]
Contact person for scientific queries
Name 54320 0
Ms Shirley Vallance
Address 54320 0
c/o Intensive Care Research
Alfred Hospital
PO Box 315
Prahran
VIC 3181
Australia
Country 54320 0
Australia
Phone 54320 0
+61 438220852
Fax 54320 0
+61 3 90762343
Email 54320 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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