Phase 3
N=120
Study Comparing Desirudin With Heparin to Prevent Vein Clots After Heart and Lung Surgery
Deep Venous Thrombosis
Bottom Line
View on ClinicalTrials.gov: NCT00329433 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Jun 2011
Primary outcome: 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. — 6; 8 participants — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Desirudin (Iprivask™) (Drug); Heparin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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. |
6; 8 | <0.05 sig |
| SECONDARY The Incidence of DVTs in Each Group. |
3; 2 | <0.05 sig |
| SECONDARY The Incidence of Bleeding in Each Group. |
2; 2 | <0.05 sig |
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; this is referred to as pulmonary embolism (PE). After heart surgery the incidence of DVT ranges from 20-48% and following lung surgery the incidence is 19-26%. In order to decrease the likelihood of this complication, patients receive by injection a blood thinning medicine. Heparin is the usual medicine used for this purpose following heart and lung surgery. Recently there have been reports that other medicines may be more effective than heparin for this purpose. Also there have been reports that some patients develop antibodies to heparin. When this occurs, this may prevent the heparin from being effective and may even promote the formation of blood clots. Antibodies to heparin may be present more often following heart and lung surgery than other types of surgery. There is a new medicine called desirudin (Iprivask), which may be used instead of heparin to prevent blood clots following heart and lung surgery. Desirudin is currently approved by the FDA to prevent blood clots following hip surgery. The purpose of this study is to compare desirudin with heparin for the prevention of vein clots after heart and lung surgery.
Eligibility Criteria
Inclusion Criteria
- Patients who are scheduled for elective Cardiac or Thoracic Surgery.
- Age > 18 years of age.
Exclusion Criteria
- 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 1.5 or aPTT > 45 sec)
- Patients with liver disease
- Pregnancy
- Patients who require ventricular assist devices before or after surgery
Data sourced from ClinicalTrials.gov (NCT00329433). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.