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

Deep Venous Thrombosis Clinical Trial

Official title:

The Use of Desirudin Versus Heparin for Thrombosis Prophylaxis in Cardiothoracic Surgery Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00329433
• Other study ID #: 05-0969
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: May 2006
• Est. completion date: October 2008

Study information

• Verified date: June 2011
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deep Venous Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

Drug:
• Desirudin (Iprivask™)
Patients who are randomized to the desirudin (study) group will receive 15 mg of subcutaneous desirudin twice a day (at 0900 and 2100). These patients will also receive an injection of normal saline placebo at 1300 so that patients in both groups will receive three injections at the same time points.
• Heparin
The patients who are randomized to the Heparin (standard of care) group will receive subcutaneous injections of heparin three times a day (0900, 1300 and 2100).

Locations

Country	Name	City	State
United States	Barnes-Jewish Hospital	Saint Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Washington University School of Medicine	Barnes-Jewish Hospital, Canyon Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	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.	30 days after surgery
Secondary	The Incidence of DVTs in Each Group.		7 days after surgery
Secondary	The Incidence of Bleeding in Each Group.		Up to 30 days after surgery