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.

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Key information

Conditions

Pulmonary Embolism Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Intermountain Medical Center

Murray, Utah, 84157, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Outpatient Treatment of Pulmonary Embolism

Other

Patients who participate in the study will be treated for their pulmonary embolism in an outpatient setting instead of being hospitalized.

Primary outcomes

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 outcomes

Reduction of medical costs due to outpatient treatment.

Time frame: 90 Days
Level of patient satisfaction as measured by survey.

Time frame: 90 Days Post study enrollment

Sponsors and collaborators

Lead sponsor

Intermountain Health Care, Inc.

Other

Registry information

Official study title

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

Acronym: Low Risk PE

Important dates

Study start: 2012
Primary completion: 2017
Study completion: 2017
First posted: Feb 4, 2015
Registry last updated: Nov 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed