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

March 30, 2009 updated by: St. Antonius Hospital

Home Treatment of Patients With Pulmonary Embolism Based on Pro-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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Nieuwegein, Netherlands, 3430 EM
        • St Antonius hospital
      • Utrecht, Netherlands, 3503 RP
        • Mesos Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Antonius Hospital

Collaborators

Diakonessenhuis, Utrecht
Groene Hart Ziekenhuis
Reinier de Graaf Hospital, Delft

Investigators

  • Study Director: Douwe H Biesma, D.H., St. Antonius Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

April 3, 2007

First Submitted That Met QC Criteria

April 3, 2007

First Posted (Estimate)

April 4, 2007

Study Record Updates

Last Update Posted (Estimate)

March 31, 2009

Last Update Submitted That Met QC Criteria

March 30, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LTME/VL-06.12
  • HOME

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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