NCT01779648

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 30, 2013

Completed
2 months until next milestone

Results Posted

Study results publicly available

April 10, 2013

Completed
Last Updated

May 1, 2013

Status Verified

April 1, 2013

Enrollment Period

10 months

First QC Date

January 27, 2013

Results QC Date

February 23, 2013

Last Update Submit

April 24, 2013

Conditions

Venous ThrombosisDeep Vein Thrombosis

Keywords

deep vein thrombosisintermittent pneumatic compressionvenous hemodynamics

Outcome Measures

Primary Outcomes (1)

  • 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.

    On 4th postoperative days after total knee replacement arthroplasty

Secondary Outcomes (11)

  • Peak Velocity

    On 4th postoperative days after total knee replacement arthroplasty

  • Mean Velocity

    On 4th postoperative days after total knee replacement arthroplasty

  • Peak Volume Flow

    On 4th postoperative days after total knee replacement arthroplasty

  • Total Volume Flow

    On 4th postoperative days after total knee replacement arthroplasty

  • Expelled Total Volume

    On 4th postoperative days after total knee replacement arthroplasty

  • +6 more secondary outcomes

Study Arms (2)

Simultaneous compression+Fixed refill time

ACTIVE COMPARATOR

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

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

Device: SCD Express

Interventions

DVT-3000DEVICE
Also known as: Simultaneous sequential intermittent pneumatic compression, Fixed venous refill time
Simultaneous compression+Fixed refill time
SCD ExpressDEVICE
Also known as: Alternate and sequential intermittent pneumatic comression, Adjusted venous refill time
Alternate compression+Adjusted refill time

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • the patients who undergo total knee replacement arthroplasty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SMG-SNU Boramae Medical Center

Seoul, 156-707, South Korea

Location

MeSH Terms

Conditions

Venous Thrombosis

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Principal Investigator
Organization
SMG-SNU Boramae Medical Center
turejsreal@hanmail.net
+82-10-9988-2691

Study Officials

  • Jae-Sung Choi, Ph.D.

    SMG-SNU Boramae Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professior, Thoracic and Cardiovascular Department

Study Record Dates

First Submitted

January 27, 2013

First Posted

January 30, 2013

Study Start

March 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

May 1, 2013

Results First Posted

April 10, 2013

Record last verified: 2013-04

Locations

KR(1)