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Comparison of Different Intermittent Pneumatic Compression Devices for Deep Vein Thrombosis

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Seoul National University

Status

Completed

Conditions

Deep Vein Thrombosis
Venous Thrombosis

Treatments

Device: DVT-3000
Device: SCD Express

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Enrollment

54 patients

Sex

All

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

54 participants in 2 patient groups

Simultaneous compression+Fixed refill time
Active Comparator group
Description:
Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression
Treatment:
Device: DVT-3000
Alternate compression+Adjusted refill time
Active Comparator group
Description:
alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression
Treatment:
Device: SCD Express

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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