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Trial registered on ANZCTR


Registration number
ACTRN12612001071819
Ethics application status
Approved
Date submitted
8/04/2011
Date registered
8/10/2012
Date last updated
8/10/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised study to compare the technical difficulty of retrieval between the Bard G2X and the Cook Celect Vena Cava Filter systems
Scientific title
A randomised study to compare the technical difficulty of retrieval between the Bard G2X and the Cook Celect Vena Cava Filter systems in patients at high risk for pulmonary embolism
Secondary ID [1] 259956 0
N/A
Universal Trial Number (UTN)
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
retrievability of off the shelf IVC filters 265584 0
Condition category
Condition code
Cardiovascular 265729 265729 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Compararing the retrievability of 2 TGA approved IVC filters.

IVC filters are implanted if you are at risk of developing a pulmonary embolus - eg if you have multiple fractures in your legs or if your blood has a tendency to form clots. The procedure involves placing a metal filter into the large vein just beneath the heart. The procedure is done while you are under sedation with image guidance and takes about half an hour. The filter sits at the end of a long thin wire that is placed into your vein at the site of either your neck or groin and is moved along the vein till the end of the wire is at the position of the IVC. The filter is then released from the wire, it opens and sits across the IVC filtering the blood of any clots that may be coming up from the legs. Once your risk of developing a clot is over the filter is removed with a similar procedure to the placement. The retrieval invloves using a hook at the end of the wire which is used to connect to the filter and then the filter is pulled back and removed form the vein. The retrieval takes about an hour.
Intervention code [1] 264367 0
Treatment: Devices
Intervention code [2] 284283 0
Treatment: Surgery
Comparator / control treatment
Comparing the retrievability of 2 TGA approved IVC filters.
One group will be randomised to receiving the Cook Filter and the other group will be randomised to the Bard filter. We will then determine which of the two filters is easier to remove.
Control group
Active

Outcomes
Primary outcome [1] 266490 0
Technical difficulty of retrieval will be assessed by the radiologist using a 5 point numerical scale.
Timepoint [1] 266490 0
The time point of the outcome, retrieving the filter, will vary based on the clinical need of the patient. The filter will be removed when the patient is no longer at risk of developing a pulmonary embolus.
Secondary outcome [1] 273889 0
Composite Serious Adverse Events
Examples of expected adverse events include
10 in 100 chance of haemorrhage (bleeding) and perforation (tearing) of the blood vessel
4 in 100 chance of pulmonary embolus (blood clot in the lung)
10 in 100 chance of occlusion (blockage) of the blood vessel
Less than 16 in 100 chance of significant filter migration (shifting in position)
10 in 100 chance of fracture of the filter
<1 in 100 chance of procedure-related death
Timepoint [1] 273889 0
procedure; 1, 3, 6 12 months; time of retrieval

Eligibility
Key inclusion criteria
1. Any patient considered at high risk for pulmonary embolism and is under consideration for placement of a short-term VCF. The patient should have at least one of the following 7 indications.
a. Patients with evidence of pulmonary embolus or IVC, iliac, or femoral-popliteal deep venous thrombosis and a contraindication, complication, or failure of anticoagulation.
b. Massive pulmonary embolism with residual deep venous thrombus in a patient at risk for further PE.
c. Free-floating iliofemoral or IVC thrombus.
d. Severe cardiopulmonary disease and deep venous thrombosis (e.g., cor pulmonale with pulmonary hypertension).
e. Poor compliance with anticoagulant medications.
f. Severe trauma without documented PE or DVT in patient with a closed head injury, spinal cord injury, or multiple long bone or pelvic fractures.
g. High-risk patients (e.g., immobilized, intensive care patients, prophylactic pre-operative placement in patients with multiple risk factors for venous thromboembolism).
2. Patient must have patent internal jugular vein.
3. Age: great than or equal to 18 years
4. Patient or person responsible must have signed the informed consent form.
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Age < 18 years.
2. Pregnancy.
3. Uncontrollable coagulopathy.
4. Vena cava diameter over 30 mm, measured by vena cava sizing catheters.
5. Vena cava diameter less than 15 mm, measured by vena cava sizing catheters.
6. Contrast allergy that cannot be adequately pre-medicated.
7. Simultaneously participating in another investigative drug or device trial, or have a previous IVC filter.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Consecutive patients referred from trauma, orthopoedics and/or haematology for IVC filter placement, who are within the inclusion exclusion criteria are approached by the radiology research coordinator. A radomisation list will be generated by the biostatistician, sealed envelopes will be prepared, numbered consecutively and contain the radomisation allocation. The envelopes will be opened when the patient is on the procedure table.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sequence was generated by The hospital biostatistician using computerised sequence generation. Sealed numbered evelopes with the randomisation allocation are drawn after consent is obtained.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
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 in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264842 0
Self funded/Unfunded
Name [1] 264842 0
Address [1] 264842 0
Country [1] 264842 0
Primary sponsor type
Hospital
Name
The Alfred Radiology Department
Address
Commercial Road
Melbourne, Vic 3004
Country
Australia
Secondary sponsor category [1] 263943 0
None
Name [1] 263943 0
Address [1] 263943 0
Country [1] 263943 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266808 0
The Alfred Human Research and Ethics Committee
Ethics committee address [1] 266808 0
Commercial Road
Melbourne, Vic 3004
Ethics committee country [1] 266808 0
Australia
Date submitted for ethics approval [1] 266808 0
Approval date [1] 266808 0
15/03/2010
Ethics approval number [1] 266808 0

Summary
Brief summary
Patients with multiple fractures or whose blood has a tendency to clot easily have a risk of developing a pulmonary embolus. This occurs when a clot formed in the legs, called a deep vein thrombosis, is dislodged and travels in the blood circulation to the lungs, causing difficulty in breathing and potentially death. Patients who have a risk of developing a pulmonary embolus may have a filter called a vena cava filter placed in the large vein beneath the heart. The filter stops any clots from the legs reaching the lungs. The filters are designed to be removed once the risk period is over. In some cases the filters may be difficult to remove and in a few cases may not be able to be removed at all. The design of vena cava filters and the devices used to remove them are being continually improved. There are a number of good filters with good removal devices available. The purpose of the study is to help us determine which of two commercially available vena cava filters is best designed for ease of removal. Taking less time to place and remove the filters helps to reduce the procedure time and consequently the radiation dose, the volume of contrast dye and the discomfort to patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32457 0
Address 32457 0
Country 32457 0
Phone 32457 0
Fax 32457 0
Email 32457 0
Contact person for public queries
Name 15704 0
Helen Kavnoudias
Address 15704 0
Radiology Department
The Alfred
Commercial Road
Melbourne, Vic 3004
Country 15704 0
Australia
Phone 15704 0
+61 3 90763606
Fax 15704 0
Email 15704 0
h.kavnoudias@alfred.org.au
Contact person for scientific queries
Name 6632 0
Helen Kavnoudias
Address 6632 0
Radiology Department
The Alfred Hospital
Commercial Road
Melbourne, Vic 3004
Country 6632 0
Australia
Phone 6632 0
+61 3 90763606
Fax 6632 0
Email 6632 0
h.kavnoudias@alfred.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