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

Intermountain Health Care, Inc.

Status: Completed

Conditions: Pulmonary Embolism

Treatments: Other: Outpatient Treatment of Pulmonary Embolism

Study type: Observational

Funder types: Other

Identifiers

NCT02355548

1018558

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

200 participants in 1 patient group

Outpatient Treatment

Description:

All patients eligible for the study will have their PE treated in the outpatient setting.

Treatment:

Other: Outpatient Treatment of Pulmonary Embolism