Venous ThrombosisNCT01779648
Comparison of Different Intermittent Pneumatic Compression Devices for Deep Vein Thrombosis
A study testing DVT-3000 and SCD Express in people with Venous Thrombosis and Deep Vein Thrombosis, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Various kinds of intermittent pneumatic compression devices (IPC) with particular ways of compression have been developed and used for prevention of deep vein thrombosis. There are still some controversies about the physiologic properties and clinical impact of numerous issues including the variety of the cuff length… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Venous Thrombosis, Deep Vein Thrombosis
- What is being tested?
- DVT-3000 and SCD Express
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2012to Jan 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- the patients who undergo total knee replacement arthroplasty
Who cannot join
- (1) chronic superficial or deep venous insufficiency, (2) venous anomalies like duplication of the superficial femoral vein, (3) previous venous thromboembolism history, (4) being under anticoagulation therapy, (5) severe arteriosclerosis obliterans without palpable dorsalis pedis pulse, (6) open fracture, hemorrhagic condition, or extensive dermatitis at lower legs, (7) congestive heart failure. Additional exclusion criteria included a documented malignant tumor, because pharmacologic prophylaxis with anticoagulants would be more reasonable in this case.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of the Different Ways of Pneumatic Compression on Clinical and Physiologic Efficacies in Preventing Deep Vein Thrombosis: a Randomised Comparative Study
Various kinds of intermittent pneumatic compression devices (IPC) with particular ways of compression have been developed and used for prevention of deep vein thrombosis.
There are still some controversies about the physiologic properties and clinical impact of numerous issues including the variety of the cuff length, inflation rate, compression sequence, compression-relaxation cycle rate, and pressure generation characteristics.
This study is designed to compare clinical efficacies as well as venous hemodynamic improvements between Simultaneous bilateral compression with fixed venous refill time versus alternate compression with adjusted refill time
- Conditions
- Venous Thrombosis, Deep Vein Thrombosis
- Being tested
- DVT-3000, SCD Express
- Keywords
- deep vein thrombosis, intermittent pneumatic compression, venous hemodynamics
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DVT-3000Device
Also called Simultaneous sequential intermittent pneumatic compression, Fixed venous refill time
SCD ExpressDevice
Also called Alternate and sequential intermittent pneumatic comression, Adjusted venous refill time
| Study group | Role | What they receive |
|---|---|---|
| Simultaneous compression+Fixed refill time | Active comparator | Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression Receives: Device: DVT-3000 |
| Alternate compression+Adjusted refill time | Active comparator | alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression Receives: Device: SCD Express |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Deep Vein Thrombosis
Computed tomographic angiography were performed on 4th postoperative days to detect deep vein thrombosis and evaluate its extent and location.
Measured: On 4th postoperative days after total knee replacement arthroplasty
Secondary outcomes (11)
Peak Velocity
Doppler ultrasonography were performed to measure one of the venous hemodynamic parameters to be compared. A longitudinal scans of bilateral superficial femoral veins, just distal to the confluence of the profunda femoral veins, were performed. Baseline velocity, flow pattern, and augmented flow of 11 seconds (Simultaneous compression arm) or 12 seconds (Alternate compression arm) were recorded. Under fixed state of other ultrasound scan parameters, peak velocity (PV) was measured by determination of maximum point of the augmented waveform.
Measured: On 4th postoperative days after total knee replacement arthroplasty
Mean Velocity
Doppler ultrasonography were performed to measure one of the venous hemodynamic parameters to be compared. A longitudinal scans of bilateral superficial femoral veins, just distal to the confluence of the profunda femoral veins, were performed. Baseline velocity, flow pattern, and augmented flow of 11 seconds (Alternate compression arm) or 12 seconds (Simultaneous compression arm) were recorded. This is an automatically measured mean value of venous flow.
Measured: On 4th postoperative days after total knee replacement arthroplasty
Peak Volume Flow
Doppler ultrasonography were performed to measure one of the venous hemodynamic parameters to be compared. A longitudinal scans of bilateral superficial femoral veins, just distal to the confluence of the profunda femoral veins, were performed. Baseline velocity, flow pattern, and augmented flow of 11 seconds (Simultaneous compression arm) or 12 seconds (Alternate compression arm) were recorded. Peak volume flow (PVF) was automatically calculated with 1-second interval around the PV.
Measured: On 4th postoperative days after total knee replacement arthroplasty
Total Volume Flow
Doppler ultrasonography were performed to measure one of the venous hemodynamic parameters to be compared. A longitudinal scans of bilateral superficial femoral veins, just distal to the confluence of the profunda femoral veins, were performed. Baseline velocity, flow pattern, and augmented flow of 11 seconds (Simultaneous compression arm) or 12 seconds (Alternate compression arm) were recorded. Total volume flow (TVF) was automatically calculated by the software.
Measured: On 4th postoperative days after total knee replacement arthroplasty
Expelled Total Volume
Expelled volume was theoretically calculated value in order to figure out how much blood was squeezed by the compression for an hour; expelled total volume (ETV) = single cycle augmented TVF x cycling rate (cycles/hour).
Measured: On 4th postoperative days after total knee replacement arthroplasty
Expelled Peak Volume
Expelled volume was theoretically calculated value in order to figure out how much blood was squeezed by the compression for an hour; expelled peak volume (EPV) = single cycle augmented PVF x cycling rate (cycles/hour).
Measured: On 4th postoperative days after total knee replacement arthroplasty
Augmented PV
Enhanced peak velocity by application of intermittent pneumatic compression
Measured: On 4th postoperative days after total knee replacement arthroplasty
Augmented MV
Enhanced mean velocity by application of pneumatic compression
Measured: On 4th postoperative days after total knee replacement arthroplasty
Augmented PVF
Enhanced peak volume flow by application of pneumatic compression
Measured: On 4th postoperative days after total knee replacement arthroplasty
Augmented TVF
Enhanced total volume flow by application of pneumatic compression
Measured: on 4th postoperative day after total knee replacement arthroplasty
Cycling Rate
Number of cuff inflation-deflation cycle during an hour. In group SF, the cycling rate is fixed as 90 cycles/hour, but in group AA, it is variable according to the individual venous refill time.
Measured: on 4th postoperative day after total knee replacement arthroplasty
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2013 (estimated)
- Study startMar 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Venous ThrombosisStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- DS MAREF Co., Ltd., Small and Medium Business Administration, KOREA
- Responsible party
- Principal investigator, Jae-Sung Choi, Seoul National University Hospital
- Investigators
- Jae-Sung Choi, Ph.D., Principal investigator, SMG-SNU Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01779648
- Sponsor's protocol ID
- IPCDVT
- Status last verified
- Apr 2013
- First submitted
- 27 Jan 2013
- Last updated
- 1 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of the Different Ways of Pneumatic Compression on Clinical and Physiologic Efficacies in Preventing Deep Vein Thrombosis: a Randomised Comparative Study
- ClinicalTrials.gov ID
- NCT01779648
- Acronym / sponsor ID
- IPCDVT
- Conditions
- Venous Thrombosis, Deep Vein Thrombosis
- Keywords
- deep vein thrombosis, intermittent pneumatic compression, venous hemodynamics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- DS MAREF Co., Ltd., Small and Medium Business Administration, KOREA
- Study start
- Mar 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 30 Jan 2013 (estimated)
- Results
- Posted 10 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Various kinds of intermittent pneumatic compression devices (IPC) with particular ways of compression have been developed and used for prevention of deep vein thrombosis.
There are still some controversies about the physiologic properties and clinical impact of numerous issues including the variety of the cuff length, inflation rate, compression sequence, compression-relaxation cycle rate, and pressure generation characteristics.
This study is designed to compare clinical efficacies as well as venous hemodynamic improvements between Simultaneous bilateral compression with fixed venous refill time versus alternate compression with adjusted refill time
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simultaneous compression+Fixed refill time | Active comparator | Device: DVT-3000Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression |
| Alternate compression+Adjusted refill time | Active comparator | Device: SCD Expressalternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- the patients who undergo total knee replacement arthroplasty
Key exclusion criteria (1 listed)
- (1) chronic superficial or deep venous insufficiency, (2) venous anomalies like duplication of the superficial femoral vein, (3) previous venous thromboembolism history, (4) being under anticoagulation therapy, (5) severe arteriosclerosis obliterans without palpable dorsalis pedis pulse, (6) open fracture, hemorrhagic condition, or extensive dermatitis at lower legs, (7) congestive heart failure. Additional exclusion criteria included a documented malignant tumor, because pharmacologic prophylaxis with anticoagulants would be more reasonable in this case.
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 |
|---|---|---|
| DVT-3000Also: Simultaneous sequential intermittent pneumatic compression, Fixed venous refill time | Device | Simultaneous compression+Fixed refill time |
| SCD ExpressAlso: Alternate and sequential intermittent pneumatic comression, Adjusted venous refill time | Device | Alternate compression+Adjusted refill time |
Primary outcome
Rate of Deep Vein Thrombosis
Time frame: On 4th postoperative days after total knee replacement arthroplasty
Computed tomographic angiography were performed on 4th postoperative days to detect deep vein thrombosis and evaluate its extent and location.
11 secondary outcomes
Peak Velocity
Time frame: On 4th postoperative days after total knee replacement arthroplasty
Mean Velocity
Time frame: On 4th postoperative days after total knee replacement arthroplasty
Peak Volume Flow
Time frame: On 4th postoperative days after total knee replacement arthroplasty
Total Volume Flow
Time frame: On 4th postoperative days after total knee replacement arthroplasty
Expelled Total Volume
Time frame: On 4th postoperative days after total knee replacement arthroplasty
Expelled Peak Volume
Time frame: On 4th postoperative days after total knee replacement arthroplasty
Augmented PV
Time frame: On 4th postoperative days after total knee replacement arthroplasty
Augmented MV
Time frame: On 4th postoperative days after total knee replacement arthroplasty
Augmented PVF
Time frame: On 4th postoperative days after total knee replacement arthroplasty
Augmented TVF
Time frame: on 4th postoperative day after total knee replacement arthroplasty
Cycling Rate
Time frame: on 4th postoperative day after total knee replacement arthroplasty
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jae-Sung Choi, Ph.D. principal investigator
SMG-SNU Boramae Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DVT-3000 and SCD Express in people with Venous Thrombosis and Deep Vein Thrombosis, run by Seoul National University Hospital at 1 site in South Korea.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 1 May 2013. 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 South Korea. 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?
Yes. Results are posted in the registry (first posted 10 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Rate of Deep Vein Thrombosis (time frame: On 4th postoperative days after total knee replacement arthroplasty). 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 1 May 2013.