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Completed

NCT Number: NCT00455819

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Antonius Hospital, Nieuwegein, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

home treatment

Procedure

Primary outcomes

  1. Mortality rate due to pulmonary embolism or its treatment during a period of ten days in the outpatient group

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

St. Antonius Hospital

Other

Collaborators

  • Diakonessenhuis, Utrecht
  • Groene Hart Ziekenhuis
  • Reinier de Graaf Groep

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Apr 4, 2007
Registry last updated
Mar 31, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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