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

Completed · Not applicable

Conditions studied: Deep Vein Thrombosis, Pulmonary Embolism

In brief

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.

Key facts

Study ID: NCT00413374
Run by: Brigham and Women's Hospital
People needed: 40
Starts: 2006-05-01
Expected to finish: 2008-12-01
Last updated by the study team: 2018-06-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Brigham and Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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