Vena Cava FiltersNCT01995877
Evaluation of the Influence of Body Position on the Inferior Vena Cava (IVC) Diameter
An observational study of Vena Cava Filters, run by University of Michigan at 1 site in United States.
Trial summary
To determine if laying down or standing up changes the diameter of the inferior vena cava. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vena Cava Filters
- What is being tested?
- Subjects scheduled for IVC filter placement
- Type of treatment
- Surgery or procedure
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Apr 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who are receiving an IVC(inferior vena cava) filter as part of their standard therapy.
Who may be able to join
- 18 years of age and older
- Subjects who will have a clinically indicated IVC filter placement procedure scheduled.
- Only subjects with no contraindications to being elevated up to a standing or near standing position on the angiography table.
- -
Who cannot join
- Pregnant
- Have a broken leg or any other physical condition that won't allow you to stand.
- If you are in a traction device
- If you have a brain injury and require special monitoring of the pressure in the brain.
- Patients on a ventilator cannot participate in this study.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Hospital
Ann Arbor, Michigan, 48109
About this study
To determine if laying down or standing up changes the diameter of the inferior vena cava.
Read the detailed description
Patients are referred for IVC(inferior vena cava)filter placement secondary to trauma, surgery, a fractured pelvis or known blood clots in the lower extremities. The filter is placed to prevent blood clots from traveling into the lungs. The filters are placed during a interventional radiology procedure. During the procedure the diameter of the IVC(inferior vena cava)is measured with the patient in a horizontal position (laying down). The blood pressure in the IVC when a patient is in this position is relatively low in normal circumstances, but may increase substantially when the patient is vertical with secondary dilation of the IVC(inferior vena cava).
Migration of IVC(inferior vena cava)filters is not frequent; however it is a serious complication, which may be caused by changes in the diameter of the IVC(inferior vena cava)related to changes in the position of the body and/or increased pressure in the abdomen.
The purpose of this study is to evaluate how much postural changes of the body affect the diameter of the IVC(inferior vena cava).
For research purposes patients will have an intravascular ultrasound (IVUS) performed to measure the IVC diameter before and after a Valsalva maneuver (having the subject hold their breath and bear down as if they were having a bowel movement). The angiographic table will be elevated and the measurements will be repeated.
- Conditions
- Vena Cava Filters
- Being tested
- Subjects scheduled for IVC filter placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subjects scheduled for IVC filter placementProcedure or surgery
Also called IVUS(intra vascular ultrasound)
Subjects will have an intra vascular ultrasound (IVUS) performed while lying down on the exam table; this will be performed before and after the IVC (inferior vena cava) filter is placed. During the ultrasound, measurements of the diameter of different areas of the IVC will be taken. The table will then be moved so that you are in a standing position and the measurements will be taken again.
The ultrasound will be done by the physician performing your procedure. When you are lying down, a sheath (small catheter) will be inserted into a vein in your groin. The IVUS (intra vascular ultrasound) catheter will be inserted through the sheath and used to measure the size of the IVC at various places.
The IVUS procedure will add about 30-45 minutes to the filter placement procedure.
| Study group | Role | What they receive |
|---|---|---|
| Subjects scheduled for IVC filter placement | A filter may be needed to be placed in the IVC (inferior vena cava) to prevent blood clots from traveling from legs to lungs. Patients who have had a pelvic fracture, or have blood clots in the leg(s) may need an IVC. Filter placement may be ordered when a patient is scheduled for major surgery and extensive bed rest. Receives: Procedure: Subjects scheduled for IVC filter placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body postural changes and the effect on the diameter of the inferior vena cava.
Migration of IVC filters is not frequent; however it is a serious complication, which may be caused by changes in the diameter of the IVC related to changes in the position of the body and/or increased pressure in the abdomen.
The purpose of this study is to evaluate how much postural changes of the body affect the diameter of the IVC.
Measured: 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2013 (estimated)
- Study startOct 2010
- Primary completionApr 2012
- Study completionApr 2012
Why it stopped: Poor recruitment, PI leaving university
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vena Cava FiltersStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Bard Ltd
- Responsible party
- Principal investigator, Ranjith Vellody, University of Michigan
- Investigators
- Ranjith Vellody, M.D., Principal investigator, University of Michigan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01995877
- Sponsor's protocol ID
- HUM00034464
- Status last verified
- May 2017
- First submitted
- 21 Nov 2013
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Influence of Body Position on the Inferior Vena Cava (IVC) Diameter
- ClinicalTrials.gov ID
- NCT01995877
- Acronym / sponsor ID
- HUM00034464
- Conditions
- Vena Cava Filters
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Poor recruitment, PI leaving university
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Bard Ltd
- Study start
- Oct 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 27 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine if laying down or standing up changes the diameter of the inferior vena cava.
Detailed description
Patients are referred for IVC(inferior vena cava)filter placement secondary to trauma, surgery, a fractured pelvis or known blood clots in the lower extremities. The filter is placed to prevent blood clots from traveling into the lungs. The filters are placed during a interventional radiology procedure. During the procedure the diameter of the IVC(inferior vena cava)is measured with the patient in a horizontal position (laying down). The blood pressure in the IVC when a patient is in this position is relatively low in normal circumstances, but may increase substantially when the patient is vertical with secondary dilation of the IVC(inferior vena cava).
Migration of IVC(inferior vena cava)filters is not frequent; however it is a serious complication, which may be caused by changes in the diameter of the IVC(inferior vena cava)related to changes in the position of the body and/or increased pressure in the abdomen.
The purpose of this study is to evaluate how much postural changes of the body affect the diameter of the IVC(inferior vena cava).
For research purposes patients will have an intravascular ultrasound (IVUS) performed to measure the IVC diameter before and after a Valsalva maneuver (having the subject hold their breath and bear down as if they were having a bowel movement). The angiographic table will be elevated and the measurements will be repeated.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects scheduled for IVC filter placement | – | Procedure: Subjects scheduled for IVC filter placementA filter may be needed to be placed in the IVC (inferior vena cava) to prevent blood clots from traveling from legs to lungs. Patients who have had a pelvic fracture, or have blood clots in the leg(s) may need an IVC. Filter placement may be ordered when a patient is scheduled for major surgery and extensive bed rest. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who are receiving an IVC(inferior vena cava) filter as part of their standard therapy.
Key inclusion criteria (4 listed)
- 18 years of age and older
- Subjects who will have a clinically indicated IVC filter placement procedure scheduled.
- Only subjects with no contraindications to being elevated up to a standing or near standing position on the angiography table.
- -
Key exclusion criteria (6 listed)
- Pregnant
- Have a broken leg or any other physical condition that won't allow you to stand.
- If you are in a traction device
- If you have a brain injury and require special monitoring of the pressure in the brain.
- Patients on a ventilator cannot participate in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subjects scheduled for IVC filter placementAlso: IVUS(intra vascular ultrasound)Subjects will have an intra vascular ultrasound (IVUS) performed while lying down on the exam table; this will be performed before and after the IVC (inferior vena cava) filter is placed. During the ultrasound, measurements of the diameter of different areas of the IVC will be taken. The table will then be moved so that you are in a standing position and the measurements will be taken again. The ultrasound will be done by the physician performing your procedure. When you are lying down, a sheath (small catheter) will be inserted into a vein in your groin. The IVUS (intra vascular ultrasound) catheter will be inserted through the sheath and used to measure the size of the IVC at various places. The IVUS procedure will add about 30-45 minutes to the filter placement procedure. | Procedure or surgery | Subjects scheduled for IVC filter placement |
Primary outcome
Body postural changes and the effect on the diameter of the inferior vena cava.
Time frame: 45 minutes
Migration of IVC filters is not frequent; however it is a serious complication, which may be caused by changes in the diameter of the IVC related to changes in the position of the body and/or increased pressure in the abdomen. The purpose of this study is to evaluate how much postural changes of the body affect the diameter of the IVC.
Results and safety
The study was stopped early (reason given: Poor recruitment, PI leaving university). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ranjith Vellody, M.D. principal investigator
University of Michigan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vena Cava Filters, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Poor recruitment, PI leaving university). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body postural changes and the effect on the diameter of the inferior vena cava. (time frame: 45 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2017.