Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000879763
Ethics application status
Approved
Date submitted
25/07/2013
Date registered
7/08/2013
Date last updated
26/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Investigation of efficacy of novel first aid treatments for envenomation from snake bite
Scientific title
In simulated snakebite, can first aid with cold packs or pressure pads, compared to no first aid, significantly delay arrival of mock venom into the systemic circulation
Secondary ID [1] 282865 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Envenomisation by snakebite 289678 0
Condition category
Condition code
Injuries and Accidents 289995 289995 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
For the baseline study a simulated snakebite will be performed by injecting the lower leg of the patient subcutaneously with 10MBq of technetium-99m antinomy sulphur colloid in a volume of 0.1ml.
After the administration of the radiotracer, the patient will undergo imaging on a gamma camera until tracer activity is evident in an inguinal lymph node. The time taken for this to occur will be recorded.
Following the inguinal node visualisation, the gamma camera will be positioned over the liver and imaging will commence. The time taken for the tracer to be visualised in the liver will be recorded.

This process will be repeated for the following interventions:


* Application of a pressure pad to the simulated snake bite area immediately following the tracer injection. The pressure pad will comprise an approx 5cm square, 2cm high cube of gauze dressing. Pressure will be applied by a sphygmomanometer cuff using a pressure of 60mmHg.

* Application of a pressure pad to the simulated snake bite area in the same manner as above but the gamma camera imaging will be interspersed with treadmill walking at 2 km/hour with no elevation. Each episode of walking will last 5 minutes followed by 5 minutes of gamma camera imaging. This will continue until tracer activity is seen in the inguinal nodes and liver.

* Application of a cold pack to the simulated snake bite area immediately after the tracer injection. The cold pack will comprise of a waterproof bag containing crushed ice and mixed with water to maintain a skin temperature under the cold pack in the range of 2-7 degrees.

The patients will undergo all four studies with each study occurring at least two days apart.

Intervention code [1] 287561 0
Prevention
Intervention code [2] 287562 0
Treatment: Other
Comparator / control treatment
The baseline comparator is the timed lymphatic drainage of the simulated snakebite in patients who will not receive any intervention methods
Control group
Active

Outcomes
Primary outcome [1] 290052 0
To assess the ability of cold packs to slow the lymphatic flow in the human model of a simulated snake bite using lymphoscintigraphy
Timepoint [1] 290052 0
Utilising gamma camera imaging, the primary time point will be the comparison of the time taken for the radiotracer to be visualised in the inguinal node and liver between the baseline study and the cold pack intervention study.
Primary outcome [2] 290053 0
To assess the ability of a pressure pad to slow the lymphatic flow in the human model of a simulated snake bite using lymphoscintigraphy
Timepoint [2] 290053 0
Utilising gamma camera imaging, the primary time point will be the comparison of the time taken for the radiotracer to be visualised in the inguinal node and liver between the baseline study and the pressure pad intervention study.
Secondary outcome [1] 303834 0
To determine whether the pressure pad method would also allow a snake bite victim to walk safely.
Timepoint [1] 303834 0
Utilising gamma camera imaging, the secondary time point will be the comparison of the time taken for the radiotracer to be visualised in the inguinal node and liver between the baseline study, the pressure pad intervention study and the pressure pad with treadmill walking intervention study.

Eligibility
Key inclusion criteria
18 years or older
Able to give informed consent
Willing to undergo injection of radiotracer and lymphoscintigraphy
Willing to receive topical therapy on lower limbs
Able to walk gently on a treadmill in 5 minute sessions every ten minutes until an exercise end point in reached
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pregnancy
Breast feeding
History of lymphatic disease
Lower limb vascular insufficiency (venous or arterial)
Previous trauma or major surgery to the lower limb
Skin at risk of injury from pressure pad or cold pack
Peripheral sensory neuropathy
Diabetes Mellitus
Ankle oedema
Allergy to radiotracer
Severe osteoarthritis or any possible impairment to mobility
Unable to give informed consent
Institutionalised
Prisoners
Participants requiring interpreters or attendants, those with LOTE, cognitive impairment or highly dependent on medical care.

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)
Recruitment will occur by internal notices targeting Queensland Health Staff and community advertising targeting members of community groups who may have an interest in snakebite first aid.

Each volunteer will undergo baseline imaging and all 3 interventions.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
1/08/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 1348 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 7182 0
4029 - Royal Brisbane Hospital

Funding & Sponsors
Funding source category [1] 287646 0
Hospital
Name [1] 287646 0
Private Practice Trust Fund The Royal Brisbane and Womens Hospital (RBWH)
Country [1] 287646 0
Australia
Primary sponsor type
Individual
Name
Dr Paul Thomas
Address
Department of Nuclear Medicine
Level 3 Ned Hanlon Building, RBWH
Butterfield Street,
Herston Qld 4029
Country
Australia
Secondary sponsor category [1] 286387 0
Individual
Name [1] 286387 0
Prof. Dirk Van Heldon
Address [1] 286387 0
The School of Biomedical Sciences and Pharmacy, Faculty of Health.
The University of Newcastle,
University Drive,
Callaghan NSW 2308
Country [1] 286387 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289615 0
RBWH HREC
Ethics committee address [1] 289615 0
Human Research and Ethics Committee
The Royal Brisbane and Womens Hospital
Butterfield Street
Herston Qld 4029
Ethics committee country [1] 289615 0
Australia
Date submitted for ethics approval [1] 289615 0
26/11/2012
Approval date [1] 289615 0
21/02/2013
Ethics approval number [1] 289615 0
HREC/12/QRBW/450

Summary
Brief summary
Each year over 100,000 people die of snake bite, some of whom are Australian. The current recommended first aid (applying a pressure bandage and immobilising the victim) can be very effective but this method of first aid is often not performed correctly. We are trying to identify simpler and more effective methods, and methods that might allow the victim to still walk to get help.
The research will NOT use snakes or snakebites or snake venom!
The aim is to measure how fast it takes for a simulated snake bite, “mock venom”, to reach the blood stream after an injection in the skin in the participants leg. comparisons will be made, on separate days, with different new methods of first aid (a pressure pad or a cold pack applied over the simulated bite site). A further aim will be to test to see if the pressure pad method still works when the participant walks slowly on a treadmill.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41562 0
Dr Paul Thomas
Address 41562 0
The Department of Nuclear Medicine
Level 3, Ned Hanlon Building
The Royal Brisbane and Womens Hospital
Butterfield Street
Herston Qld 4029
Country 41562 0
Australia
Phone 41562 0
+61 (07) 36467271
Fax 41562 0
Email 41562 0
paul_thomas@health.qld.gov.au
Contact person for public queries
Name 41563 0
Dr Paul Thomas
Address 41563 0
The Department of Nuclear Medicine
Level 3, Ned Hanlon Building
The Royal Brisbane and Womens Hospital
Butterfield Street
Herston Qld 4029
Country 41563 0
Australia
Phone 41563 0
+61 (07) 36467271
Fax 41563 0
Email 41563 0
paul_thomas@health.qld.gov.au
Contact person for scientific queries
Name 41564 0
Dr Paul Thomas
Address 41564 0
The Department of Nuclear Medicine
Level 3, Ned Hanlon Building
The Royal Brisbane and Womens Hospital
Butterfield Street
Herston Qld 4029
Country 41564 0
Australia
Phone 41564 0
+61 (07) 36467271
Fax 41564 0
Email 41564 0
paul_thomas@health.qld.gov.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

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