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Outpatient Treatment of Low-risk Pulmonary Embolism (Low Risk PE)

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: NCT02355548
Recruitment Status : Completed
First Posted : February 4, 2015
Last Update Posted : November 29, 2018
Sponsor:
Information provided by (Responsible Party):
Intermountain Health Care, Inc.

Study Description
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Brief Summary:
This study is looking at the safety and effectiveness of treating Patients diagnosed with a low-risk Pulmonary Embolism (PE) in an outpatient setting instead of the standard, in-patient hospitalization. Patients have several medical tests done during their Emergency Department visit. Based on those tests, those who are determined to have a low-risk PE are eligible to participate in the study. Those choosing to participate are discharged after 12 hours of medical observation. Patients who choose to participate are followed up by telephone approximately 90 days later.

Condition or disease Intervention/treatment
Pulmonary Embolism Other: Outpatient Treatment of Pulmonary Embolism

Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Rapid Risk Stratification for Outpatient Treatment of Low-risk Pulmonary Embolism
Study Start Date : December 2012
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Outpatient Treatment
All patients eligible for the study will have their PE treated in the outpatient setting.
 Other: Outpatient Treatment of Pulmonary Embolism
Patients who participate in the study will be treated for their pulmonary embolism in an outpatient setting instead of being hospitalized.


Outcome Measures
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Primary Outcome Measures :
  1. 90-day all-cause mortality, recurrent VTE, and Major Bleeding during outpatient treatment of Low-risk PE [ Time Frame: 90 Days ]
    This is a composite outcome of the above.


Secondary Outcome Measures :
  1. Reduction of medical costs due to outpatient treatment. [ Time Frame: 90 Days ]
  2. Level of patient satisfaction as measured by survey. [ Time Frame: 90 Days Post study enrollment ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The subject population is drawn from patients arriving in the Emergency Department who are then diagnosed with a lower risk pulmonary embolism (PESI score <86).
Criteria

Inclusion Criteria:

  1. Pulmonary Embolism, diagnosed by CTA or high probability VQ Scan
  2. Total Pulmonary Embolism Severity Index (PESI) score <86

Exclusion Criteria:

  1. Massive Pulmonary Embolism: Hypotension with signs of right heart strain on CTA or Echocardiogram
  2. Sustained Systolic Blood Pressure (SBP) <95 mmHg during Emergency Department or observation stay.
  3. Age <18
  4. Pregnant
  5. Renal insufficiency (Creatinine Clearance <30)
  6. Hepatic Dysfunction (AST/ALT/ALP > 3 times upper limit of normal)
  7. Unreliable social situation or inability to follow up
  8. Contraindication to enoxaparin, warfarin and rivaroxaban
  9. Atrial or ventricular dysrhythmia(s)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02355548


Locations
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United States, Utah
Intermountain Medical Center
Murray, Utah, United States, 84157
Sponsors and Collaborators
Intermountain Health Care, Inc.
Investigators
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Principal Investigator: Joseph Bledsoe, MD Intermountain Health Care, Inc.
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier: NCT02355548    
Other Study ID Numbers: 1018558
First Posted: February 4, 2015    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: November 2018
Additional relevant MeSH terms:
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Pulmonary Embolism
Embolism
Embolism and Thrombosis
Vascular Diseases
 Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases