Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Study Comparing Desirudin With Heparin to Prevent Vein Clots After Heart and Lung Surgery

This study has been completed.
Sponsor:
Collaborators:
Barnes-Jewish Hospital
Canyon Pharmaceuticals, Inc.
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00329433
First received: May 22, 2006
Last updated: June 14, 2011
Last verified: June 2011
Results First Received: March 11, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Deep Venous Thrombosis
Interventions: Drug: Desirudin (Iprivask™)
Drug: Heparin

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Desirudin Patients randomized to the desirudin group received desirudin 15mg via subcutaneous administration twice daily (0900 and 2100), with saline placebo given once daily at 1300.
Heparin Patients randomized to the heparin group received 5000 units of LDUH via subcutaneous administration three times a day (0900, 1300, and 2100).

Participant Flow:   Overall Study
    Desirudin   Heparin
STARTED   61   59 
COMPLETED   61   59 
NOT COMPLETED   0   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
Desirudin Patients randomized to the desirudin group received desirudin 15mg via subcutaneous administration twice daily (0900 and 2100), with saline placebo given once daily at 1300.
Heparin Patients randomized to the heparin group received 5000 units of LDUH via subcutaneous administration three times a day (0900, 1300, and 2100).
Total Total of all reporting groups

Baseline Measures
   Desirudin   Heparin   Total 
Overall Participants Analyzed 
[Units: Participants]
 61   59   120 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   38   39   77 
>=65 years   23   20   43 
Age 
[Units: Years]
Mean (Standard Deviation)
 62  (11)   61  (12)   61  (11) 
Gender 
[Units: Participants]
     
Female   26   22   48 
Male   35   37   72 
Region of Enrollment 
[Units: Participants]
     
United States   61   59   120 


  Outcome Measures

1.  Primary:   The Primary Outcome Measure Was the Number of Participants With New Heparin Platelet Factor 4 (HIT Positive) Antibodies in Each Group Within 30 Days Following Surgery.   [ Time Frame: 30 days after surgery ]

2.  Secondary:   The Incidence of DVTs in Each Group.   [ Time Frame: 7 days after surgery ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   The Incidence of Bleeding in Each Group.   [ Time Frame: Up to 30 days after surgery ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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
The study size was small and a surrogate end point was the primary outcome. The study was not powered to show statistical differences in clinical outcomes. Many patients received both desirudin and heparin during the study.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Michael S. Avidan, MBBCh
Organization: Washington University School of Medicine
phone: 314-747-4155
e-mail: avidanm@wustl.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Michael S. Avidan MBBCh, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00329433     History of Changes
Other Study ID Numbers: 05-0969
Study First Received: May 22, 2006
Results First Received: March 11, 2011
Last Updated: June 14, 2011