Safety Study of Outpatient Treatment for Pulmonary Embolism (OTPE)

This study has been completed.
Sponsor:
Collaborators:
Swiss National Science Foundation
Information provided by:
University of Lausanne Hospitals
ClinicalTrials.gov Identifier:
NCT00425542
First received: January 22, 2007
Last updated: June 10, 2010
Last verified: October 2009
  Purpose

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.


Condition Intervention Phase
Pulmonary Embolism
Other: Outpatient care (vs traditional inpatient care)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Outpatient Treatment of Low-risk Patients With Pulmonary Embolism: a Randomized-controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Lausanne Hospitals:

Primary Outcome Measures:
  • Recurrent, symptomatic venous thromboembolism (deep vein thrombosis or pulmonary embolism) [ Time Frame: within 3 months of randomization ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Major bleeding [ Time Frame: within 3 months of randomization ] [ Designated as safety issue: Yes ]
  • All-cause mortality [ Time Frame: within 3 months of randomization ] [ Designated as safety issue: Yes ]
  • Patient satisfaction with care [ Time Frame: within 2 weeks of randomization ] [ Designated as safety issue: No ]
  • Medical resource utilization [ Time Frame: within 3 months of randomization ] [ Designated as safety issue: No ]

Enrollment: 343
Study Start Date: January 2007
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Ambulatory care
No Intervention: Inpatient care

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00425542

Locations
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States
United States, Pennsylvania
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, United States
Belgium
University Hospital Saint-Luc, Université Catholique de Louvain
Brussels, Belgium, 1200
University of Leuven
Leuven, Belgium, 3000
France
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 Henri Mondor, Créteil
Paris, France
Hôpital Européen Georges Pompidou
Paris, France
Thiers
Thiers, France
Switzerland
Kantonsspital Baden
Baden, Switzerland
University of Geneva
Geneva, Switzerland, 1211
University Hospital of Lausanne
Lausanne, Switzerland, 1011
Kantonsspital St. Gallen
St. Gallen, Switzerland, 9007
Sponsors and Collaborators
University of Lausanne Hospitals
Swiss National Science Foundation
Investigators
Principal Investigator: Drahomir Aujesky, MD, MSc University of Lausanne, Switzerland
Principal Investigator: Donald M Yealy, MD University of Pittsburgh
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Drahomir Aujesky, MD, MSc, University of Lausanne
ClinicalTrials.gov Identifier: NCT00425542     History of Changes
Obsolete Identifiers: NCT00974207
Other Study ID Numbers: 3200B0-112165, 1R01HL085565-01A2
Study First Received: January 22, 2007
Last Updated: June 10, 2010
Health Authority: Switzerland: Swissmedic

Keywords provided by University of Lausanne Hospitals:
Pulmonary embolism
Outpatient care
Prognosis

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Cardiovascular Diseases
Embolism and Thrombosis
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014