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Safety Study of Outpatient Treatment for Pulmonary Embolism (OTPE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00425542
Recruitment Status : Completed
First Posted : January 23, 2007
Last Update Posted : June 11, 2010
Sponsor:
Collaborators:
Swiss National Science Foundation
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
University of Lausanne Hospitals

Tracking Information
First Submitted Date  ICMJE January 22, 2007
First Posted Date  ICMJE January 23, 2007
Last Update Posted Date June 11, 2010
Study Start Date  ICMJE January 2007
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 24, 2007)
Recurrent, symptomatic venous thromboembolism (deep vein thrombosis or pulmonary embolism) [ Time Frame: within 3 months of randomization ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 22, 2007)
Recurrent, symptomatic venous thromboembolism (deep vein thrombosis or pulmonary embolism)
Change History Complete list of historical versions of study NCT00425542 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 24, 2007)
  • Major bleeding [ Time Frame: within 3 months of randomization ]
  • All-cause mortality [ Time Frame: within 3 months of randomization ]
  • Patient satisfaction with care [ Time Frame: within 2 weeks of randomization ]
  • Medical resource utilization [ Time Frame: within 3 months of randomization ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2007)
  • Major bleeding
  • All-cause mortality
  • Medical resource utilization
  • Patient satisfaction with care
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of Outpatient Treatment for Pulmonary Embolism
Official Title  ICMJE Outpatient Treatment of Low-risk Patients With Pulmonary Embolism: a Randomized-controlled Trial
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 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Pulmonary Embolism
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: Outpatient treatment
    Intervention: Other: Outpatient care (vs traditional inpatient care)
  • No Intervention: Inpatient care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 10, 2010)
343
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   France,   Switzerland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00425542
Other Study ID Numbers  ICMJE 3200B0-112165
1R01HL085565-01A2 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Drahomir Aujesky, MD, MSc, University of Lausanne
Study Sponsor  ICMJE University of Lausanne Hospitals
Collaborators  ICMJE
  • Swiss National Science Foundation
  • National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Drahomir Aujesky, MD, MSc University of Lausanne, Switzerland
Principal Investigator: Donald M Yealy, MD University of Pittsburgh
PRS Account University of Lausanne Hospitals
Verification Date October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP