Comparison of Different Intermittent Pneumatic Compression Devices for Deep Vein Thrombosis

NCT ID: NCT01779648

Last Updated: 2013-05-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-01-31

Brief Summary

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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

Detailed Description

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Conditions

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Venous Thrombosis Deep Vein Thrombosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Simultaneous compression+Fixed refill time

Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression

Group Type ACTIVE_COMPARATOR

DVT-3000

Intervention Type DEVICE

Alternate compression+Adjusted refill time

alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression

Group Type ACTIVE_COMPARATOR

SCD Express

Intervention Type DEVICE

Interventions

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DVT-3000

Intervention Type DEVICE

SCD Express

Intervention Type DEVICE

Other Intervention Names

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Simultaneous sequential intermittent pneumatic compression Fixed venous refill time Alternate and sequential intermittent pneumatic comression Adjusted venous refill time

Eligibility Criteria

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Inclusion Criteria

* the patients who undergo total knee replacement arthroplasty
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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DS MAREF Co., Ltd.

UNKNOWN

Sponsor Role collaborator

Small and Medium Business Administration, KOREA

UNKNOWN

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jae-Sung Choi

Associate Professior, Thoracic and Cardiovascular Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jae-Sung Choi, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

SMG-SNU Boramae Medical Center

Locations

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SMG-SNU Boramae Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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IPCDVT

Identifier Type: -

Identifier Source: org_study_id

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