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

St. Antonius Hospital

Status: Completed

Conditions: Pulmonary Embolism

Treatments: Procedure: home treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT00455819

HOME

LTME/VL-06.12

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)