We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of Different Intermittent Pneumatic Compression Devices for Deep Vein Thrombosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01779648
First Posted: January 30, 2013
Last Update Posted: May 1, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
DS MAREF Co., Ltd.
Small and Medium Business Administration, KOREA
Information provided by (Responsible Party):
Jae-Sung Choi, Seoul National University Hospital
Results First Submitted: February 23, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Prevention
Conditions: Venous Thrombosis
Deep Vein Thrombosis
Interventions: Device: DVT-3000
Device: SCD Express

  Participant Flow
  Hide Participant Flow

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
  Hide Baseline Characteristics

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 
Overall Participants Analyzed 
[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


  Limitations and Caveats
  Hide 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.


  More Information
  Hide More Information

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


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



Responsible Party: Jae-Sung Choi, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01779648     History of Changes
Other Study ID Numbers: IPCDVT
First Submitted: January 27, 2013
First Posted: January 30, 2013
Results First Submitted: February 23, 2013
Results First Posted: April 10, 2013
Last Update Posted: May 1, 2013