Clinical trial NCT00329433: Study Comparing Desirudin With Heparin to Prevent Vein Clots After Heart and Lung Surgery
Official title: The Use of Desirudin Versus Heparin for Thrombosis Prophylaxis in Cardiothoracic Surgery Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Deep Venous Thrombosis
Keywords: Deep venous thrombosis
DVT
Heparin induced thrombocytopenia
HIT
Direct thrombin inhibitor
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Barnes-Jewish Hospital
name: Canyon Pharmaceuticals, Inc.
First posted: 2006-05-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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; 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\< 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

Primary outcomes:
measure: 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.
timeFrame: 30 days after surgery
Secondary outcomes:
measure: The Incidence of DVTs in Each Group.
timeFrame: 7 days after surgery
measure: The Incidence of Bleeding in Each Group.
timeFrame: Up to 30 days after surgery
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Michael S Avidan, MBBCh
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Charles Hantler, MD
role: STUDY_DIRECTOR
affiliation: Washington University School of Medicine
name: Bryan Meyers, MD
role: STUDY_CHAIR
References:
citation: Graetz TJ, Tellor BR, Smith JR, Avidan MS. Desirudin: a review of the pharmacology and clinical application for the prevention of deep vein thrombosis. Expert Rev Cardiovasc Ther. 2011 Sep;9(9):1101-9. doi: 10.1586/erc.11.131.
citation: Avidan MS, Smith JR, Skrupky LP, Hill L, Jacobsohn E, Burnside B, Tymkew H, Eby C, Damiano R, Despotis GJ. The occurrence of antibodies to heparin-platelet factor 4 in cardiac and thoracic surgical patients receiving desirudin or heparin for postoperative venous thrombosis prophylaxis. Thromb Res. 2011 Dec;128(6):524-9. doi: 10.1016/j.thromres.2011.05.025. Epub 2011 Jul 26.