Safety Study of Outpatient Treatment for Pulmonary Embolism

Completed · Phase 3

Conditions studied: Pulmonary Embolism

In brief

The purpose of this randomized clinical trial is to determine whether outpatient treatment is as effective and safe as inpatient treatment among low-risk patients with pulmonary embolism.

Key facts

Study ID

NCT00425542

Run by

University of Lausanne Hospitals

People needed

343

Starts

2007-01-01

Expected to finish

2010-06-01

Last updated by the study team

2010-06-11

Who can join

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

You may qualify if…

• age >18 years
• objectively confirmed diagnosis of pulmonary embolism
• patients at low-risk (Pulmonary Embolism Severity Index score <=85)

You may not qualify if…

• patients at high-risk (Pulmonary Embolism Severity Index score >85)
• presence of hypoxemia (arterial SO2 <90% measured by pulse oximetry or an paO2 on room air of <60 mm Hg measured by blood gas analysis)
• systolic blood pressure of <100 mm Hg
• chest pain necessitating parenteral opioid administration
• active bleeding or at high-risk of major bleeding (stroke during the preceding 10 days, gastrointestinal bleeding during the preceding 14 days, or platelets <75,000 per mm3)
• renal failure (creatinine clearance of <30 ml/minute based on the Cockcroft-Gault formula)
• body mass >150 kg
• history of HIT or allergy to heparins
• therapeutic oral anticoagulation (INR ≥2)at the time of pulmonary embolism diagnosis
• potential barriers to treatment adherence or follow-up (alcoholism, illicit current or recent drug use, psychosis, dementia, homelessness, lack of telephone access, transportation time to nearest ED >45 minutes)
• known pregnancy
• imprisonment
• diagnosis of pulmonary embolism >23 hours ago
• refusal or inability to provide informed consent
• prior enrollment in the study

Where it is running

• Northwestern Memorial Hospital — Chicago, Illinois, United States
• Carolinas Medical Center — Charlotte, North Carolina, United States
• UPMC Presbyterian Hospital — Pittsburgh, Pennsylvania, United States
• University Hospital Saint-Luc, Université Catholique de Louvain — Brussels, Belgium
• University of Leuven — Leuven, Belgium
• University of Angers — Angers, France
• University of Argenteuil — Argenteuil, France
• University of Boulogne — Boulogne, France
• University Hospital of Brest — Brest, France
• University of Clermont-Ferrand — Clermont-Ferrand, France
• University of Dijon — Dijon, France
• University of Nantes — Nantes, France
• Hôpital Européen Georges Pompidou — Paris, France
• Hôpital Henri Mondor, Créteil — Paris, France
• Thiers — Thiers, France
• Kantonsspital Baden — Baden, Switzerland
• University of Geneva — Geneva, Switzerland
• University Hospital of Lausanne — Lausanne, Switzerland
• Kantonsspital St. Gallen — Sankt Gallen, Switzerland

Full record on ClinicalTrials.gov

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