Safety Study of Outpatient Treatment for Pulmonary Embolism (OTPE)

June 10, 2010 updated by: University of Lausanne Hospitals

Outpatient Treatment of Low-risk Patients With Pulmonary Embolism: a Randomized-controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 diagnosis of PE in 2002, resulting in direct medical costs of $720 million. There is growing evidence that outpatient treatment with low-molecular-weight heparin (LMWH) is an effective and safe option for up to 50% of patients with non-massive PE. Despite this evidence, outpatient treatment of PE is uncommon because (1) explicit criteria that identify patients who are at low-risk of adverse medical outcomes have not been available, and (2) randomized trials demonstrating the effectiveness and safety of outpatient treatment have not been performed. We developed a clinical prognostic model that accurately identifies patients with PE who are at low-risk for short-term mortality, symptomatic recurrent venous thromboembolism (VTE), and major bleeding. This model provides clinicians an easily applied, explicit risk stratification tool for patients with PE, addressing a key barrier to outpatient treatment. The broad objective of this clinical trial is to address the other major barrier to outpatient treatment of low-risk patients with non-massive PE, the effectiveness and safety of outpatient management. We will randomize low-risk patients (identified using our prognostic model) with PE from hospital emergency departments to receive outpatient or inpatient treatment with LMWH for ≥5 days, followed by oral anticoagulation. The specific aims of the project are to compare (1) the frequency of recurrent VTE, (2) the frequency of major bleeding and all-cause mortality, and (3) medical resource utilization and patient satisfaction with care among patients randomized to receive outpatient or inpatient treatment with LMWH. The primary study outcome will be the rate of symptomatic recurrent VTE at 3 months after randomization. The secondary outcomes will be the rate of major bleeding and all-cause mortality. The ancillary outcomes will be medical resource utilization and patient satisfaction with care. The hypotheses guiding this trial are that outpatient treatment with LMWH is as effective and safe as inpatient treatment with LMWH, and is also associated with reduced medical resource utilization and increase patient satisfaction with care. This study is innovative because it translates a validated prognostic model into clinical practice and represents the first direct comparison of outpatient versus inpatient treatment of low-risk patients with PE. Successful completion of this project will provide a strong scientific basis for treating low-risk patients with PE in the outpatient setting. Outpatient management of low-risk patients with PE is likely to improve quality and efficiency of care by reducing resource utilization and increasing patient satisfaction with care. Our findings will have importance to physicians, hospitals, and policy-makers who are committed to optimizing patient safety and providing high-quality, cost-effective care.

Study Type

Interventional

Enrollment (Actual)

343

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • University Hospital Saint-Luc, Université Catholique de Louvain
      • Leuven, Belgium, 3000
        • University of Leuven
  • France
      • Angers, France
        • University of Angers
      • Argenteuil, France
        • University of Argenteuil
      • Boulogne, France
        • University of Boulogne
      • Brest, France
        • University Hospital of Brest
      • Clermont-Ferrand, France
        • University of Clermont-Ferrand
      • Dijon, France
        • University of Dijon
      • Nantes, France
        • University of Nantes
      • Paris, France
        • Hopital Europeen Georges Pompidou
      • Paris, France
        • Hopital Henri Mondor, Creteil
      • Thiers, France
        • Thiers
  • Switzerland
      • Baden, Switzerland
        • Kantonsspital Baden
      • Geneva, Switzerland, 1211
        • University of Geneva
      • Lausanne, Switzerland, 1011
        • University Hospital of Lausanne
      • St. Gallen, Switzerland, 9007
        • Kantonsspital St. Gallen
  • United States
    • Illinois
      • Chicago, Illinois, United States
        • Northwestern Memorial Hospital
    • North Carolina
      • Charlotte, North Carolina, United States
        • Carolinas Medical Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States
        • UPMC Presbyterian Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Outpatient treatment
Other: Outpatient care (vs traditional inpatient care)
Patients randomized to the outpatient arm are discharged from the emergency department within 24 hours after randomization. Patients randomized to the inpatient arm are admitted to the hospital and are discharged based on the decision of the managing physician at the hospital.
Other Names:
  • Ambulatory care
No Intervention: Inpatient care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recurrent, symptomatic venous thromboembolism (deep vein thrombosis or pulmonary embolism)
Time Frame: within 3 months of randomization
within 3 months of randomization

Secondary Outcome Measures

Outcome Measure
Time Frame
Major bleeding
Time Frame: within 3 months of randomization
within 3 months of randomization
All-cause mortality
Time Frame: within 3 months of randomization
within 3 months of randomization
Patient satisfaction with care
Time Frame: within 2 weeks of randomization
within 2 weeks of randomization
Medical resource utilization
Time Frame: within 3 months of randomization
within 3 months of randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lausanne Hospitals

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
Swiss National Science Foundation

Investigators

  • Principal Investigator: Donald M Yealy, MD, University of Pittsburgh
  • Principal Investigator: Drahomir Aujesky, MD, MSc, University of Lausanne, Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

January 22, 2007

First Submitted That Met QC Criteria

January 22, 2007

First Posted (Estimate)

January 23, 2007

Study Record Updates

Last Update Posted (Estimate)

June 11, 2010

Last Update Submitted That Met QC Criteria

June 10, 2010

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3200B0-112165
  • 1R01HL085565-01A2 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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