N/A
N=55
Comparison of Different Intermittent Pneumatic Compression Devices for Deep Vein Thrombosis
Venous Thrombosis · Deep Vein Thrombosis
Bottom Line
View on ClinicalTrials.gov: NCT01779648 ↗Enrolled (actual)
55
Serious AEs
0.0%
Results posted
Apr 2013
Primary outcome: Primary: Rate of Deep Vein Thrombosis — 14; 15; 9; 12 participants — p=0.785
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- DVT-3000 (Device); SCD Express (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Seoul National University Hospital
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Deep Vein Thrombosis |
14; 15; 9; 12; 1; 1 | 0.785 |
| SECONDARY Peak Velocity |
24.8; 22.8 | 0.195 |
| SECONDARY Mean Velocity |
10.0; 9.7 | 0.722 |
| SECONDARY Peak Volume Flow |
205.3; 176.4 | 0.158 |
| SECONDARY Total Volume Flow |
160.9; 144.2 | 0.301 |
| SECONDARY Expelled Total Volume |
7214.0; 4342.0; 6102.8; 3334.5 | <0.001 sig |
| SECONDARY Expelled Peak Volume |
999.8; 633.1; 904.0; 525.5 | <0.001 sig |
| SECONDARY Augmented PV |
62.8; 56.2; 57.1; 58.5 | 0.929 |
| SECONDARY Augmented MV |
20.4; 18.2; 33.1; 18.3 | — |
| SECONDARY Augmented PVF |
666.5; 514.6; 602.7; 465.0 | 0.008 sig |
| SECONDARY Augmented TVF |
400.7; 324.2; 339.0; 271.2 | 0.132 |
| SECONDARY Cycling Rate |
90; 78.9 | — |
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
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.
Data sourced from ClinicalTrials.gov (NCT01779648). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.