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;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Deep Venous Thrombosis
Interventions: Drug: Desirudin (Iprivask™)
Drug: Heparin

  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
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
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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
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  
Number of Participants  
[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.   Safety Issue:   No

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.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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


No publications provided by Washington University School of Medicine

Publications automatically indexed to this study:

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
Health Authority: United States: Food and Drug Administration