NCT02355548
Completed
Not Applicable
Rapid Risk Stratification for Outpatient Treatment of Low-risk Pulmonary Embolism
ConditionsPulmonary Embolism
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pulmonary Embolism
- Sponsor
- Intermountain Health Care, Inc.
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- 90-day all-cause mortality, recurrent VTE, and Major Bleeding during outpatient treatment of Low-risk PE
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
- •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)
Outcomes
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
- Level of patient satisfaction as measured by survey.(90 Days Post study enrollment)
- Reduction of medical costs due to outpatient treatment.(90 Days)
Study Sites (1)
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