Comparison of Different Intermittent Pneumatic Compression Devices for Deep Vein Thrombosis

This study has been completed.
Sponsor:
Collaborators:
DS MAREF Co., Ltd.
Small and Medium Business Administration, KOREA
Information provided by (Responsible Party):
Jae-Sung Choi, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01779648
First received: January 27, 2013
Last updated: April 24, 2013
Last verified: April 2013
Results First Received: February 23, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Prevention
Conditions: Venous Thrombosis
Deep Vein Thrombosis
Interventions: Device: DVT-3000
Device: SCD Express

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The recruitment started in March, 2012 and ended in January, 2013. A total 57 participants were recruited and tested for enrollment after admission to the hospital.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Two of them were excluded prior to group assignment because of the detection of a lung cancer and a deep vein thrombosis, respectively.

Reporting Groups
  Description
Group SF

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

Simultaneous compression +Fixed refill time:

Group AA

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

Alternate compression+Adjusted refill time


Participant Flow:   Overall Study
    Group SF     Group AA  
STARTED     28     27  
COMPLETED     27     27  
NOT COMPLETED     1     0  
Protocol Violation                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Group SF

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

simultaneous compression :

Group AA

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

alternate compression :

Total Total of all reporting groups

Baseline Measures
    Group SF     Group AA     Total  
Number of Participants  
[units: participants]
  28     27     55  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     8     1     9  
>=65 years     20     26     46  
Age  
[units: years]
Mean ± Standard Deviation
  68.0  ± 8.1     72.3  ± 5.9     70.1  ± 7.4  
Gender  
[units: participants]
     
Female     26     24     50  
Male     2     3     5  
Region of Enrollment  
[units: participants]
     
Korea, Republic of     28     27     55  
Body Mass Index  
[units: kg/m2]
Mean ± Standard Deviation
     
Female     27.1  ± 5.2     26.3  ± 4.4     26.7  ± 4.8  
Male     26.5  ± 4.6     28.0  ± 1.6     27.4  ± 2.7  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Rate of Deep Vein Thrombosis   [ Time Frame: On 4th postoperative days after total knee replacement arthroplasty ]

2.  Secondary:   Peak Velocity   [ Time Frame: On 4th postoperative days after total knee replacement arthroplasty ]

3.  Secondary:   Mean Velocity   [ Time Frame: On 4th postoperative days after total knee replacement arthroplasty ]

4.  Secondary:   Peak Volume Flow   [ Time Frame: On 4th postoperative days after total knee replacement arthroplasty ]

5.  Secondary:   Total Volume Flow   [ Time Frame: On 4th postoperative days after total knee replacement arthroplasty ]

6.  Secondary:   Expelled Total Volume   [ Time Frame: On 4th postoperative days after total knee replacement arthroplasty ]

7.  Secondary:   Expelled Peak Volume   [ Time Frame: On 4th postoperative days after total knee replacement arthroplasty ]

8.  Secondary:   Augmented PV   [ Time Frame: On 4th postoperative days after total knee replacement arthroplasty ]

9.  Secondary:   Augmented MV   [ Time Frame: On 4th postoperative days after total knee replacement arthroplasty ]

10.  Secondary:   Augmented PVF   [ Time Frame: On 4th postoperative days after total knee replacement arthroplasty ]

11.  Secondary:   Augmented TVF   [ Time Frame: on 4th postoperative day after total knee replacement arthroplasty ]

12.  Secondary:   Cycling Rate   [ Time Frame: on 4th postoperative day after total knee replacement arthroplasty ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Principal Investigator
Organization: SMG-SNU Boramae Medical Center
phone: +82-10-9988-2691
e-mail: turejsreal@hanmail.net


No publications provided


Responsible Party: Jae-Sung Choi, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01779648     History of Changes
Other Study ID Numbers: IPCDVT
Study First Received: January 27, 2013
Results First Received: February 23, 2013
Last Updated: April 24, 2013
Health Authority: South Korea: Institutional Review Board