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

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ClinicalTrials.gov Identifier: NCT00329433
Recruitment Status : Completed
First Posted : May 24, 2006
Results First Posted : June 13, 2011
Last Update Posted : March 5, 2019
Sponsor:
Collaborators:
Barnes-Jewish Hospital
Canyon Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Michael Avidan, Washington University School of Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Deep Venous Thrombosis
Interventions Drug: Desirudin (Iprivask™)
Drug: Heparin
Enrollment 120
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Desirudin Heparin
Hide Arm/Group Description 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. Patients randomized to the heparin group received 5000 units of LDUH via subcutaneous administration three times a day (0900, 1300, and 2100).
Period Title: Overall Study
Started 61 59
Completed 61 59
Not Completed 0 0
Arm/Group Title Desirudin Heparin Total
Hide Arm/Group Description 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. Patients randomized to the heparin group received 5000 units of LDUH via subcutaneous administration three times a day (0900, 1300, and 2100). Total of all reporting groups
Overall Number of Baseline Participants 61 59 120
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 59 participants 120 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
38
  62.3%
39
  66.1%
77
  64.2%
>=65 years
23
  37.7%
20
  33.9%
43
  35.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 61 participants 59 participants 120 participants
62  (11) 61  (12) 61  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 59 participants 120 participants
Female
26
  42.6%
22
  37.3%
48
  40.0%
Male
35
  57.4%
37
  62.7%
72
  60.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 61 participants 59 participants 120 participants
61 59 120
1.Primary Outcome
Title 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.
Hide Description Blood samples were collected and tested in singlet for the presence of PF4/heparin antibodies. Samples were collected for each participant on PDD (Post-study Drug initiation Day) 2, PDD 7 or at hospital discharge, and at 30 days post surgery.
Time Frame 30 days after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat analysis was performed according to initial group assignment.
Arm/Group Title Desirudin Heparin
Hide Arm/Group Description:
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.
Patients randomized to the heparin group received 5000 units of LDUH via subcutaneous administration three times a day (0900, 1300, and 2100).
Overall Number of Participants Analyzed 61 59
Measure Type: Number
Unit of Measure: participants
6 8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Desirudin, Heparin
Comments Published data show that the incidence of PF4/heparin EIA antibodies is approximately 40% (range, 20% to 60%) following cardiac surgery. We estimated that antibody formation would occur in approximately 20% of patients following thoracic surgery. Sixty patients in each group would provide 80% power to detect a decrease in the incidence of positive PF4/heparin EIA tests from 20% to 4% at an alpha level of <0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Secondary Outcome
Title The Incidence of DVTs in Each Group.
Hide Description [Not Specified]
Time Frame 7 days after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
61 in Desirudin group and 59 in heparin group.
Arm/Group Title Desirudin Heparin
Hide Arm/Group Description:
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.
Patients randomized to the heparin group received 5000 units of LDUH via subcutaneous administration three times a day (0900, 1300, and 2100).
Overall Number of Participants Analyzed 61 59
Measure Type: Count of Participants
Unit of Measure: Participants
3
   4.9%
2
   3.4%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Desirudin, Heparin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
3.Secondary Outcome
Title The Incidence of Bleeding in Each Group.
Hide Description [Not Specified]
Time Frame Up to 30 days after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat.
Arm/Group Title Desirudin Heparin
Hide Arm/Group Description:
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.
Patients randomized to the heparin group received 5000 units of LDUH via subcutaneous administration three times a day (0900, 1300, and 2100).
Overall Number of Participants Analyzed 61 59
Measure Type: Count of Participants
Unit of Measure: Participants
2
   3.3%
2
   3.4%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Desirudin, Heparin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Desirudin Heparin
Hide Arm/Group Description 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. Patients randomized to the heparin group received 5000 units of LDUH via subcutaneous administration three times a day (0900, 1300, and 2100).
All-Cause Mortality
Desirudin Heparin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Desirudin Heparin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/61 (0.00%)   0/59 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Desirudin Heparin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/61 (0.00%)   0/59 (0.00%) 
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.
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.
Results Point of Contact
Name/Title: Michael S. Avidan, MBBCh
Organization: Washington University School of Medicine
Phone: 314-747-4155
Responsible Party: Michael Avidan, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00329433     History of Changes
Other Study ID Numbers: 05-0969
First Submitted: May 22, 2006
First Posted: May 24, 2006
Results First Submitted: March 11, 2011
Results First Posted: June 13, 2011
Last Update Posted: March 5, 2019