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NCT Number: NCT00329433

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

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.

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Key information

Conditions

Deep Venous Thrombosis Cardiovascular Diseases Embolism and Thrombosis Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Desirudin (Iprivask™)

Drug

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

Drug

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).

Primary outcomes

  1. 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

    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 outcomes

  1. The Incidence of DVTs in Each Group.

    Time frame: 7 days after surgery

  2. The Incidence of Bleeding in Each Group.

    Time frame: Up to 30 days after surgery

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Barnes-Jewish Hospital
  • Canyon Pharmaceuticals, Inc.

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
May 24, 2006
Registry last updated
Mar 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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