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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2009-03-31

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.

Conditions

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Pulmonary Embolism

Keywords

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pulmonary embolism pro-BNP home treatment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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home treatment

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Douwe H Biesma, D.H.

Role: STUDY_DIRECTOR

St. Antonius Hospital

Locations

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St Antonius Hospital

Nieuwegein, , Netherlands

Site Status

Mesos Medical Centre

Utrecht, , Netherlands

Site Status

Countries

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Netherlands

References

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Agterof MJ, Schutgens RE, Snijder RJ, Epping G, Peltenburg HG, Posthuma EF, Hardeman JA, van der Griend R, Koster T, Prins MH, Biesma DH. Out of hospital treatment of acute pulmonary embolism in patients with a low NT-proBNP level. J Thromb Haemost. 2010 Jun;8(6):1235-41. doi: 10.1111/j.1538-7836.2010.03831.x. Epub 2010 Mar 3.

Reference Type DERIVED

PMID: 20230418 (View on PubMed)

Other Identifiers

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HOME

Identifier Type: -

Identifier Source: secondary_id

LTME/VL-06.12