Status:
COMPLETED
Once Daily Enoxaparin for Outpatient Treatment of Acute DVT and/or Pulmonary Embolism
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Sanofi
Conditions:
Deep Vein Thrombosis
Pulmonary Embolism
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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.
Detailed Description
Background and Significance: Low molecular weight heparin (LMWH) as a "bridge" to warfarin has become the standard of care for outpatient treatment of acute deep venous thrombosis (DVT). LMWH is also...
Eligibility Criteria
Inclusion
- Symptomatic acute deep venous thrombosis and/or pulmonary embolism confirmed by venous ultrasound and/or CT scan.
- Pulmonary embolism patients with normal right ventricular size on chest CT scan.
- Age greater than 18 years
- Anticipated discharge within 72 hours of admission
- Written informed consent
Exclusion
- Pregnancy or intend to become pregnant
- Patients requiring ongoing hospitalization \> 72 hours
- Hypersensitivity to heparin, pork products or enoxaparin
- Creatinine \> 2.0 mg/dl
- Recurrent DVT and/or PE with oral anticoagulation
- Surgery or medical procedure planned during the study that may pose a significant bleeding risk
- Prior history of heparin-induced thrombocytopenia
- Inability to participate for follow up appointments and study visits
- Life expectancy \< 30 days
- High risk of bleeding:
- Active major bleeding within 30 days by GUSTO criteria
- History of intracranial bleeding
- Major surgery or trauma within 10 days
- Head injury requiring hospitalization within 1 year
- Intracranial tumor
- Neurosurgery or non-cataract ophthalmologic surgery within 1 month
- Thrombocytopenia
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00413374
Start Date
May 1 2006
End Date
December 1 2008
Last Update
June 28 2018
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115