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

This study has been completed.
Sponsor:
Collaborators:
Barnes-Jewish Hospital
Canyon Pharmaceuticals, Inc.
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00329433
First received: May 22, 2006
Last updated: June 14, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Deep Venous Thrombosis
Drug: Desirudin (Iprivask™)
Drug: Heparin
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Use of Desirudin Versus Heparin for Thrombosis Prophylaxis in Cardiothoracic Surgery Patients

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • 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. [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • The Incidence of DVTs in Each Group. [ Time Frame: 7 days after surgery ] [ Designated as safety issue: No ]
  • The Incidence of Bleeding in Each Group. [ Time Frame: Up to 30 days after surgery ] [ Designated as safety issue: Yes ]

Enrollment: 120
Study Start Date: May 2006
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Heparin
Both groups of patients will receive study drug three times a day (TID) for DVT prophylaxis. The current TID schedule is 0900, 1300, and 2100. 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).
Drug: 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).
Experimental: Desirudin (Iprivask™)
Both groups of patients will receive study drug three times a day (TID) for DVT prophylaxis. The current TID schedule is 0900, 1300, and 2100. 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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00329433

Locations
United States, Missouri
Barnes-Jewish Hospital
St Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Barnes-Jewish Hospital
Canyon Pharmaceuticals, Inc.
Investigators
Principal Investigator: Michael S Avidan, MBBCh Washington University Early Recognition Center
Study Director: Charles Hantler, MD Washington University Early Recognition Center
Study Chair: Bryan Meyers, MD Washington University Early Recognition Center
  More Information

No publications provided by Washington University School of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michael S. Avidan MBBCh, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00329433     History of Changes
Other Study ID Numbers: 05-0969
Study First Received: May 22, 2006
Results First Received: March 11, 2011
Last Updated: June 14, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Washington University School of Medicine:
Deep venous thrombosis
DVT
Heparin induced thrombocytopenia
HIT
Direct thrombin inhibitor

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thromboembolism
Calcium heparin
Desirudin
Heparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on October 19, 2014