Status:
COMPLETED
Study Comparing Desirudin With Heparin to Prevent Vein Clots After Heart and Lung Surgery
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
Barnes-Jewish Hospital
Canyon Pharmaceuticals, Inc.
Conditions:
Deep Venous Thrombosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
A blood clot in the veins, also known as deep venous thrombosis (DVT), is one of the most common complications after surgery. This may result in death if a clot breaks off and travel to the lungs; thi...
Eligibility Criteria
Inclusion
- Patients who are scheduled for elective Cardiac or Thoracic Surgery.
- Age \> 18 years of age.
Exclusion
- Patients with a clinical suspicion or a documented history of DVT/PE
- Patients who may require anticoagulation during the post-op period. (i.e. Patients with a history of A-fib, scheduled for a MAZE procedure or placement of a mechanical valve, or those on Coumadin/IV heparin preoperatively)
- Patients who have a history of HIT or if there is a suspicion of the patient having HIT pre-operatively.
- Documented allergy to heparin, desirudin, or lepirudin
- Patients with a history of coagulation disorder
- Platelet count\< 100 X109 /dl
- Active bleeding
- Serum Creatinine ≥ 1.5 mg/dl or CrCl ≤ 30 ml/min
- Patients with a baseline coagulopathy (INR \> 1.5 or aPTT \> 45 sec)
- Patients with liver disease
- Pregnancy
- Patients who require ventricular assist devices before or after surgery
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00329433
Start Date
May 1 2006
End Date
October 1 2008
Last Update
March 5 2019
Active Locations (1)
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1
Barnes-Jewish Hospital
St Louis, Missouri, United States, 63110