Back to resultsComparison of Different Intermittent Pneumatic Compression Devices for Deep Vein Thrombosis
Primary Purpose
Venous Thrombosis, Deep Vein Thrombosis
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DVT-3000
SCD Express
Sponsored by
About this trial
This is an interventional prevention trial for Venous Thrombosis focused on measuring deep vein thrombosis, intermittent pneumatic compression, venous hemodynamics
Eligibility Criteria
Inclusion Criteria:
- the patients who undergo total knee replacement arthroplasty
Exclusion Criteria:
- (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.
Sites / Locations
- SMG-SNU Boramae Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Simultaneous compression+Fixed refill time
Alternate compression+Adjusted refill time
Arm Description
Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression
alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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).
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).
Augmented PV
Enhanced peak velocity by application of intermittent pneumatic compression
Augmented MV
Enhanced mean velocity by application of pneumatic compression
Augmented PVF
Enhanced peak volume flow by application of pneumatic compression
Augmented TVF
Enhanced total volume flow by application of pneumatic compression
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.
Full Information
NCT ID
NCT01779648
First Posted
January 27, 2013
Last Updated
April 24, 2013
Sponsor
Seoul National University Hospital
Collaborators
DS MAREF Co., Ltd., Small and Medium Business Administration, KOREA
1. Study Identification
Unique Protocol Identification Number
NCT01779648
Brief Title
Comparison of Different Intermittent Pneumatic Compression Devices for Deep Vein Thrombosis
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
DS MAREF Co., Ltd., Small and Medium Business Administration, KOREA
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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, 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thrombosis, Deep Vein Thrombosis
Keywords
deep vein thrombosis, intermittent pneumatic compression, venous hemodynamics
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Simultaneous compression+Fixed refill time
Arm Type
Active Comparator
Arm Description
Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression
Arm Title
Alternate compression+Adjusted refill time
Arm Type
Active Comparator
Arm Description
alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression
Intervention Type
Device
Intervention Name(s)
DVT-3000
Other Intervention Name(s)
Simultaneous sequential intermittent pneumatic compression, Fixed venous refill time
Intervention Type
Device
Intervention Name(s)
SCD Express
Other Intervention Name(s)
Alternate and sequential intermittent pneumatic comression, Adjusted venous refill time
Primary Outcome Measure Information:
Title
Rate of Deep Vein Thrombosis
Description
Computed tomographic angiography were performed on 4th postoperative days to detect deep vein thrombosis and evaluate its extent and location.
Time Frame
On 4th postoperative days after total knee replacement arthroplasty
Secondary Outcome Measure Information:
Title
Peak Velocity
Description
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.
Time Frame
On 4th postoperative days after total knee replacement arthroplasty
Title
Mean Velocity
Description
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.
Time Frame
On 4th postoperative days after total knee replacement arthroplasty
Title
Peak Volume Flow
Description
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.
Time Frame
On 4th postoperative days after total knee replacement arthroplasty
Title
Total Volume Flow
Description
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.
Time Frame
On 4th postoperative days after total knee replacement arthroplasty
Title
Expelled Total Volume
Description
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).
Time Frame
On 4th postoperative days after total knee replacement arthroplasty
Title
Expelled Peak Volume
Description
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).
Time Frame
On 4th postoperative days after total knee replacement arthroplasty
Title
Augmented PV
Description
Enhanced peak velocity by application of intermittent pneumatic compression
Time Frame
On 4th postoperative days after total knee replacement arthroplasty
Title
Augmented MV
Description
Enhanced mean velocity by application of pneumatic compression
Time Frame
On 4th postoperative days after total knee replacement arthroplasty
Title
Augmented PVF
Description
Enhanced peak volume flow by application of pneumatic compression
Time Frame
On 4th postoperative days after total knee replacement arthroplasty
Title
Augmented TVF
Description
Enhanced total volume flow by application of pneumatic compression
Time Frame
on 4th postoperative day after total knee replacement arthroplasty
Title
Cycling Rate
Description
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.
Time Frame
on 4th postoperative day after total knee replacement arthroplasty
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
the patients who undergo total knee replacement arthroplasty
Exclusion Criteria:
(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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jae-Sung Choi, Ph.D.
Organizational Affiliation
SMG-SNU Boramae Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
SMG-SNU Boramae Medical Center
City
Seoul
ZIP/Postal Code
156-707
Country
Korea, Republic of
12. IPD Sharing Statement
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Comparison of Different Intermittent Pneumatic Compression Devices for Deep Vein Thrombosis
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