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

November 28, 2018 updated by: Intermountain Health Care, Inc.

Rapid Risk Stratification for Outpatient Treatment of Low-risk Pulmonary Embolism

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

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

  • United States
    • Utah
      • Murray, Utah, United States, 84157
        • Intermountain Medical Center

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

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).

Description

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)

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

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
90 Days

Secondary Outcome Measures

Outcome Measure
Time Frame
Reduction of medical costs due to outpatient treatment.
Time Frame: 90 Days
90 Days
Level of patient satisfaction as measured by survey.
Time Frame: 90 Days Post study enrollment
90 Days Post study enrollment

Collaborators and Investigators

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

Sponsor

Intermountain Health Care, Inc.

Investigators

  • Principal Investigator: Joseph Bledsoe, MD, Intermountain Health Care, Inc.

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

December 1, 2012

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

November 18, 2014

First Submitted That Met QC Criteria

January 30, 2015

First Posted (Estimate)

February 4, 2015

Study Record Updates

Last Update Posted (Actual)

November 29, 2018

Last Update Submitted That Met QC Criteria

November 28, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1018558

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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