Study Comparing Desirudin With Heparin to Prevent Vein Clots After Heart and Lung Surgery
| Status: | Completed |
|---|---|
| Conditions: | Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/7/2019 |
| Start Date: | May 2006 |
| End Date: | October 2008 |
The Use of Desirudin Versus Heparin for Thrombosis Prophylaxis in Cardiothoracic Surgery Patients
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.
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.
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< 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
We found this trial at
1
site
Click here to add this to my saved trials
