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

Phase 2

Completed

• Conditions: Deep Venous Thrombosis
• Interventions: Drug: Desirudin (Iprivask™); Drug: Heparin

• Registration Number: NCT00329433
• Lead Sponsor: Washington University School of Medicine

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 ...

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-05-22
• Study First Submitted QC: 2006-05-22
• Study First Posted: 2006-05-24
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Results First Submitted: 2011-03-11
• Results First Submitted QC: 2011-05-11
• Status Verified: 2011-06
• Results First Posted: 2011-06-13
• Last Update Submitted: 2019-02-11
• Last Update Posted: 2019-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Patients who are scheduled for elective Cardiac or Thoracic Surgery.
• Age > 18 years of age.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Desirudin (Iprivask™)	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.
Heparin	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).

Primary Outcome Measures

Name	Time	Method
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.	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 Outcome Measures

Name	Time	Method
The Incidence of DVTs in Each Group.	7 days after surgery
The Incidence of Bleeding in Each Group.	Up to 30 days after surgery

Trial Locations

Locations (1)

Barnes-Jewish Hospital; 🇺🇸 Saint Louis, Missouri, United States