None listed
Conditions
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.
Interventions
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 y
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.
Sponsors
The Alfred Radiology Department
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed