N/A
N=120
Once Daily Enoxaparin for Outpatient Treatment of Acute DVT and/or Pulmonary Embolism
Deep Vein Thrombosis · Pulmonary Embolism
Bottom Line
View on ClinicalTrials.gov: NCT00413374 ↗Enrolled (actual)
120
Serious AEs
3.3%
Results posted
Apr 2012
Primary outcome: Primary: Major Bleeding Complication — 0; 3 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Enoxaparin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Major Bleeding Complication |
0; 3 | — |
| PRIMARY Recurrent VTE |
1; 3 | — |
| PRIMARY Death |
0; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00413374). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.