Once Daily Enoxaparin for Outpatient Treatment of Acute DVT and/or Pulmonary Embolism

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To investigate the efficacy and safety of once daily enoxaparin as a "bridge" to warfarin for the outpatient treatment of acute deep venous thrombosis or pulmonary embolism.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Collaborator: Sanofi
• Treatments: Enoxaparin

Criteria

Inclusion Criteria:

1. Symptomatic acute deep venous thrombosis and/or pulmonary embolism confirmed by venous ultrasound and/or CT scan.

2. Pulmonary embolism patients with normal right ventricular size on chest CT scan.

3. Age greater than 18 years

4. Anticipated discharge within 72 hours of admission

5. Written informed consent

Exclusion Criteria:

1. Pregnancy or intend to become pregnant

2. Patients requiring ongoing hospitalization > 72 hours

3. Hypersensitivity to heparin, pork products or enoxaparin

4. Creatinine > 2.0 mg/dl

5. Recurrent DVT and/or PE with oral anticoagulation

6. Surgery or medical procedure planned during the study that may pose a significant bleeding risk

7. Prior history of heparin-induced thrombocytopenia

8. Inability to participate for follow up appointments and study visits

9. Life expectancy < 30 days

10. High risk of bleeding:

1. Active major bleeding within 30 days by GUSTO criteria

2. History of intracranial bleeding

3. Major surgery or trauma within 10 days

4. Head injury requiring hospitalization within 1 year

5. Intracranial tumor

6. Neurosurgery or non-cataract ophthalmologic surgery within 1 month

7. Thrombocytopenia