Outpatient Treatment of Low-risk Pulmonary Embolism

Completed

• Conditions: Pulmonary Embolism
• Interventions: Other: Outpatient Treatment of Pulmonary Embolism

• Registration Number: NCT02355548
• Lead Sponsor: Intermountain Health Care, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2014-11-18
• Study First Submitted QC: 2015-01-30
• Study First Posted: 2015-02-04
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-28
• Last Update Posted: 2018-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Outpatient Treatment	Outpatient Treatment of Pulmonary Embolism	All patients eligible for the study will have their PE treated in the outpatient setting.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Intermountain Medical Center; 🇺🇸 Murray, Utah, United States