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

NCT ID: NCT00329433

Last Updated: 2019-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2008-10-31

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.

Conditions

Deep Venous Thrombosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

Heparin

Intervention Type: 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).

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.

Group Type: EXPERIMENTAL

Desirudin (Iprivask™)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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).

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Barnes-Jewish Hospital

OTHER

Sponsor Role: collaborator

Canyon Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Michael Avidan

Professor of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael S Avidan, MBBCh

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Charles Hantler, MD

Role: STUDY_DIRECTOR

Washington University School of Medicine

Bryan Meyers, MD

Role: STUDY_CHAIR

Washington University School of Medicine

Locations

Barnes-Jewish Hospital

St Louis, Missouri, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 21932952 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 21794899 (View on PubMed)

Other Identifiers

05-0969

Identifier Type: -

Identifier Source: org_study_id