Outpatient Treatment of Low-risk Pulmonary Embolism

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02355548

Acronym

Low Risk PE

Enrollment

200

Registered

2015-02-04

Start date

2012-12-31

Completion date

2017-12-31

Last updated

2018-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Embolism

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.

Interventions

OTHEROutpatient 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
90-day all-cause mortality, recurrent VTE, and Major Bleeding during outpatient treatment of Low-risk PE	90 Days	This is a composite outcome of the above.

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026