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Trial registered on ANZCTR


Registration number
ACTRN12611000424909
Ethics application status
Approved
Date submitted
19/04/2011
Date registered
27/04/2011
Date last updated
28/04/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomized controlled trial of a new light weight battery operated calf compression device (Venowave) for prevention of venous thrombosis.
Scientific title
Open label randomized controlled trial of a new calf compression device (venowave) versus no Venowave device on background of standard care for prevention of venous thromboembolism in patients undergoing neurosurgery.
Secondary ID [1] 260037 0
Nil
Universal Trial Number (UTN)
U1111-1120-8551
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
venous thrombosis prevention in neurosurgery 265696 0
Condition category
Condition code
Surgery 265833 265833 0 0
Other surgery
Blood 265855 265855 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Bilateral calf compression devices (Venowave) will be applied within 4 hours of surgery completion and will be continued for up to 24 hours per day (maximum tolerated) for study duration (7 days +/- 2 days). All patients will receive standard care consisting of early mobilization, graduated compression stockings and anticoagulant drugs as determined by their primary doctor.
Intervention code [1] 264455 0
Treatment: Devices
Intervention code [2] 264469 0
Prevention
Comparator / control treatment
Standard care will consist of early mobilization, bilateral knee length graduated compression stockings (TEDS) and anticoagulant drugs as determined by the primary doctor.
Control group
Active

Outcomes
Primary outcome [1] 266591 0
Composite of asymptomatic deep vein thrombosis (screening venogram or ultrasound) and objectively confirmed symptomatic deep vein thrombosis or pulmonary embolism.
Timepoint [1] 266591 0
Day 7 (+/- 2 days) or at discharge if earlier
Secondary outcome [1] 276074 0
Venowave tolerability will be assessed using validated patient questionnaire. I addition patients will be questioned regarding device comfort daily using a standardized data sheet. Any adverse events will be documented. Possible adverse events include pruritis, skin irritation or abrasion.
Timepoint [1] 276074 0
Day 7 (+/- 2 days) or at discharge if earlier

Eligibility
Key inclusion criteria
Patients undergoing spinal surgery, brain surgery, and patients with intracranial or subdural bleeding with paralysis
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
leg ulceration, symptomatic peripheral neuropathy, symptomatic peripheral arterial disease, allergy to contrast medium, renal failure (GFR of less than 50mL/min)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligible, consenting patients will be randomized using computer generated randomization sequence concealed in sequentially numbered, opaque sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

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 outside Australia
Country [1] 3416 0
Canada
State/province [1] 3416 0
Ontario

Funding & Sponsors
Funding source category [1] 264925 0
Government body
Name [1] 264925 0
Golden Horseshoe Network (Government of Ontario)
Address [1] 264925 0
McMaster University
1200 Main Street West
Michael G. DeGroote Centre for Learning & Discovery,
Room 5105
Hamilton, Ontario
L8N 3Z5
Country [1] 264925 0
Canada
Primary sponsor type
Hospital
Name
Hamilton Health Sciences
Address
237 Barton Street East
Hamilton ON L8L 2X2
Country
Canada
Secondary sponsor category [1] 264026 0
Individual
Name [1] 264026 0
Professor John Eikelboom
Address [1] 264026 0
237 Barton Street East
Hamilton ON L8L 2X2
Country [1] 264026 0
Canada
Other collaborator category [1] 251963 0
Individual
Name [1] 251963 0
Dr Magdalena Teague
Address [1] 251963 0
237 Barton Street East
Hamilton ON L8L 2X2
Country [1] 251963 0
Canada

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266884 0
Hamilton Health Sciences/McMaster Research Ethics Board
Ethics committee address [1] 266884 0
Health Science Centre, Room 1B7
McMaster University
1280 Main Street West
Hamilton, Ontario, Canada L8S 4K1
Ethics committee country [1] 266884 0
Canada
Date submitted for ethics approval [1] 266884 0
Approval date [1] 266884 0
17/03/2009
Ethics approval number [1] 266884 0
1/08/0576

Summary
Brief summary
The main purpose of the study is to establish if addition of Venowave devices to standard care in neurosurgical inpatients reduces the risk of venous thrombosis. We also aim to establish if the device is safe and well tolerated by patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32518 0
Address 32518 0
Country 32518 0
Phone 32518 0
Fax 32518 0
Email 32518 0
Contact person for public queries
Name 15765 0
Magdalena Teague
Address 15765 0
Hamilton Health Sciences - General Site
237 Barton Street East
Hamilton ON L8L 2X2
Country 15765 0
Canada
Phone 15765 0
Phone: +1 905-527-4322 ext 40323
Fax 15765 0
Email 15765 0
mteague@arcbs.redcross.org.au
Contact person for scientific queries
Name 6693 0
Magdalena Teague
Address 6693 0
Hamilton Health Sciences - General Site
237 Barton Street East
Hamilton ON L8L 2X2
Country 6693 0
Canada
Phone 6693 0
Phone: +1 905-527-4322 ext 40323
Fax 6693 0
Email 6693 0
mteague@arcbs.redcross.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary