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Trial registered on ANZCTR


Registration number
ACTRN12610000118000
Ethics application status
Approved
Date submitted
9/12/2009
Date registered
4/02/2010
Date last updated
16/12/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A Multicentre, Controlled Trial to Determine the Safety and Efficacy of Hypertensive Extracorporeal Limb Perfusion
(HELP) in Treating Patients with Critical Limb Ischaemia (CLI)
Scientific title
In treating patients with Critical Limb Ischaemia (CLI) using Hypertensive Extracorporeal Limb Perfusion
(HELP) when compared to conventional treatments the study evaluates Safety and Efficacy via a multicentre, controlled trial.
Secondary ID [1] 253123 0
CTN 036/2010
Universal Trial Number (UTN)
U1111-1112-6971
Trial acronym
Hypertensive Extracorporeal Limb Perfusion (HELP)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical Limb Ischemia 252333 0
Condition category
Condition code
Cardiovascular 252519 252519 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Hypertensive Extracorporeal Limb Perfusion (HELP) procedure involves the temporary surgical implantation of two large bore access ports (Peripheral Access Devices - PAD) in to the femoral artery (thigh). The devices will be implanted (2hour procedure duration) for a maximum duration of 28 days after which the devices are removed.
Pressure and Flow are then generated by an extracorporeal pump taking the patients blood from one device and returning it in to the the treatment limb. This increased flow allows an improvement in perfusion to the diseased/occluded limb. Pumping sessions will last for around 24 hours at a time and may be repeated every other day for the total treatment period (28 days)
Intervention code [1] 255639 0
Treatment: Devices
Intervention code [2] 255968 0
Treatment: Surgery
Comparator / control treatment
Historical Data of CLI Amputees determined by a literature review (worldwide meta analysis of published papers)(taken from within previous 10 years) along with a review of the investigative teams own patient databases
Control group
Historical

Outcomes
Primary outcome [1] 253404 0
Determine safety and efficacy of Hypertensive Extracorporeal Limb Perfusion in preventing major limb amputation by examination for harm (Serious Adverse Events - including Minor Amputations ,Significant infection. haematoma or haemorrhage, Clinically significant thrombosis, Haemolysis) or further treatment (amputation)
Timepoint [1] 253404 0
6 months after explantation of the PAD devices
Secondary outcome [1] 262492 0
Relief of symptoms of peripheral vascular disease - determined by thermography, ultrasound, physical examination, questionnaires
Timepoint [1] 262492 0
6 months after explantation of the PAD devices
Secondary outcome [2] 262493 0
Healing of ulcers determined by photographic records and physical examinations
Timepoint [2] 262493 0
6 months after explantation of the PAD devices
Secondary outcome [3] 262494 0
Increased distal perfusion determined by ankle brachial index (ABI) and also by ultrasound exam
Timepoint [3] 262494 0
6 months after explantation of the PAD devices

Eligibility
Key inclusion criteria
1) Only alternative treatment is imminent (within 8 weeks) major limb amputation
2) At least two vascular surgeons must agree that the treatment is the only remaining option for the patients
3) Patients must be over 18 years of age
4) Patients have critical limb ischaemia
5) Patients must be able to understand the risks and benefits of the trial and give written informed consent to participate
6) Patients must be fit for anaesthesia
7) Patients must have suitable anatomy determined by pre-operative imaging and physical examination
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Patients must not be in a concurrent clinical trial
2) Patient must not have compartment syndrome
3) Patients must not have an active systemic infection
4) Patient must not have serum abnormalities or high Creatine Phosphokinase (CPK) (greater than 3x the upper limit of normal for the testing laboratory) as deemed by the clinical investigator
5) Patients must not have general advanced debilitation or intercurrent organ failure
6) Patients must not have a serious wound infection (for example, Methicillin-resistant Staphylococcus aureus (MRSA) of the ulcer) that in the opinion of the Clinical Investigator may impede the response to treatment
7) Patients must not have disseminated intravascular coagulation (DIC) as deemed by the clinical investigator

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)
All patients are end stage referrals with no other options.
They are approved to the trial by two independent co-investigators.
All recruited patients if deemed suitable will be treated.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
There are no randomisations
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2010
Actual
7/05/2010
Date of last participant enrolment
Anticipated
Actual
3/11/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 1852 0
Dalcross Adventist Hospital - Killara

Funding & Sponsors
Funding source category [1] 256127 0
Commercial sector/Industry
Name [1] 256127 0
Advanced Surgical Design and Manufacture
Country [1] 256127 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Advanced Surgical Design and Manufacture
Address
2/12 Frederick St, St Leonards, NSW 2065
Country
Australia
Secondary sponsor category [1] 251469 0
None
Name [1] 251469 0
Address [1] 251469 0
Country [1] 251469 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258229 0
Northern Sydney Central Coast Human Research Ethics Committee (HREC)
Ethics committee address [1] 258229 0
Ethics committee country [1] 258229 0
Australia
Date submitted for ethics approval [1] 258229 0
16/11/2009
Approval date [1] 258229 0
18/03/2010
Ethics approval number [1] 258229 0
HREC/09/HARBR/160
HREC Protocol Number 0911-306M

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30573 0
Dr Rodney Lane
Address 30573 0
AllVascular Pty Ltd
Suites 13, Greenwich Square, 130-134 Pacific Highway, St Leonards NSW 2065
Country 30573 0
Australia
Phone 30573 0
+61 2 9438 5228
Fax 30573 0
Email 30573 0
HELP-Trial@asdm.com.au
Contact person for public queries
Name 13820 0
Dr Rodney Lane
Address 13820 0
AllVascular Pty Ltd
Suites 13, Greenwich Square, 130-134 Pacific Highway, St Leonards NSW 2065
Country 13820 0
Australia
Phone 13820 0
+61 2 9438 5228
Fax 13820 0
+61 2 9906 1573
Email 13820 0
HELP-Trial@asdm.com.au
Contact person for scientific queries
Name 4748 0
Dr Rodney Lane
Address 4748 0
AllVascular Pty Ltd
Suite 13, Greenwich Square, 130-134 Pacific Highway, St Leonards NSW 2065
Country 4748 0
Australia
Phone 4748 0
+61 2 9438 5228
Fax 4748 0
+61 2 9906 1573
Email 4748 0
HELP-Trial@asdm.com.au

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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.