Outpatient Treatment of Low-risk Pulmonary Embolism

Completed

Conditions studied: Pulmonary Embolism

In brief

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.

Key facts

Study ID

NCT02355548

Run by

Intermountain Health Care, Inc.

People needed

200

Starts

2012-12-01

Expected to finish

2017-12-01

Last updated by the study team

2018-11-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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)

Where it is running

• Intermountain Medical Center — Murray, Utah, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.