Home Treatment of Patients With Pulmonary Embolism Based on Pro-Brain Natriuretic Peptide (BNP) Levels

Study Overview
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Brief Summary
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The aim of this study is to investigate the safety of treatment of pulmonary embolism in an outpatient setting based on normal pro-BNP levels. The mortality rate and the incidence of hemodynamic instability as well as major bleeding and recurrent venous thromboembolism (VTE) in the outpatient group will be studied.

Detailed Description
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Pulmonary embolism is a major health problem. Because of risk for early hemodynamic instability and mortality, all patients with a recently diagnosed pulmonary embolism are treated in hospital. The clinical course of most patients is without complications. In practice most of the patients are only waiting in hospital in a good, clinical stable condition until their INR range is stable. This prospective management study is to investigate the safety of treatment of pulmonary embolism in an outpatient setting based on normal pro-BNP levels (< 500 pg/ml). The incidence of complications due to the pulmonary embolism or its treatment will be followed during the first ten days of treatment.

Official Title
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Home Treatment of Patients With Pulmonary Embolism Based on Pro-BNP Levels

Conditions
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Pulmonary Embolism

Intervention / Treatment
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* Procedure: home treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: outpatient with a pulmonary embolism, confirmed by locally approved guidelines aged 18 years and above written informed consent Exclusion Criteria: hemodynamic or respiratory instability defined as one of the following; hypotension RR systolic< 90 mmHg,pulse rate> 100 bpm, need for oxygen therapy to maintain oxygen saturation above 90 %, collapse illness unrelated to PE for which the patient would require hospitalization pain requiring intravenous narcotics thrombolysis active bleeding or thrombopathy pregnancy in hospital patients physical or psychiatric inability for home treatment no support system at home renal insufficiency

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: home treatment|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality rate due to pulmonary embolism or its treatment during a period of ten days in the outpatient group |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of re-admission due to pulmonary embolism or its treatment in the outpatient group: hemodynamic instability, major bleeding, recurrence of venous thromboembolism |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pulmonary embolism, pro-BNP, home treatment