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

Not Applicable

Completed

• Conditions: Pulmonary Embolism

• Registration Number: NCT00455819
• Lead Sponsor: St. Antonius Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2007-04-03
• Study First Submitted QC: 2007-04-03
• Study First Posted: 2007-04-04
• Status Verified: 2009-03
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Last Update Submitted: 2009-03-30
• Last Update Posted: 2009-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Mortality rate due to pulmonary embolism or its treatment during a period of ten days in the outpatient group

Secondary Outcome Measures

Name	Time	Method
Rate of re-admission due to pulmonary embolism or its treatment in the outpatient group: hemodynamic instability, major bleeding, recurrence of venous thromboembolism

Trial Locations

Locations (2)

St Antonius Hospital; 🇳🇱 Nieuwegein, Netherlands

Mesos Medical Centre; 🇳🇱 Utrecht, Netherlands