Status:
COMPLETED
Safety Study of Outpatient Treatment for Pulmonary Embolism
Lead Sponsor:
University of Lausanne Hospitals
Collaborating Sponsors:
Swiss National Science Foundation
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Pulmonary Embolism
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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.
Detailed Description
Pulmonary embolism (PE) is a worldwide health problem, with an estimated incidence of up to 69 cases per 100,000 persons annually. In the U.S., 101,000 patients were hospitalized with a primary diagno...
Eligibility Criteria
Inclusion
- age \>18 years
- objectively confirmed diagnosis of pulmonary embolism
- patients at low-risk (Pulmonary Embolism Severity Index score \<=85)
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
343 Patients enrolled
Trial Details
Trial ID
NCT00425542
Start Date
January 1 2007
End Date
June 1 2010
Last Update
June 11 2010
Active Locations (19)
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1
Northwestern Memorial Hospital
Chicago, Illinois, United States
2
Carolinas Medical Center
Charlotte, North Carolina, United States
3
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, United States
4
University Hospital Saint-Luc, Université Catholique de Louvain
Brussels, Belgium, 1200