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

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ClinicalTrials.gov Identifier: NCT00455819
Recruitment Status : Completed
First Posted : April 4, 2007
Last Update Posted : March 31, 2009
Sponsor:
Collaborators:
Diakonessenhuis, Utrecht
Groene Hart Ziekenhuis
Reinier de Graaf Hospital, Delft
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Pulmonary Embolism Procedure: home treatment Not Applicable

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  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Home Treatment of Patients With Pulmonary Embolism Based on Pro-BNP Levels
Study Start Date : December 2006
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine





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

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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00455819


Locations
Netherlands
St Antonius Hospital
Nieuwegein, Netherlands, 3430 EM
Mesos Medical Centre
Utrecht, Netherlands, 3503 RP
Sponsors and Collaborators
St. Antonius Hospital
Diakonessenhuis, Utrecht
Groene Hart Ziekenhuis
Reinier de Graaf Hospital, Delft
Investigators
Study Director: Douwe H Biesma, D.H. St. Antonius Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00455819     History of Changes
Other Study ID Numbers: LTME/VL-06.12
HOME
First Posted: April 4, 2007    Key Record Dates
Last Update Posted: March 31, 2009
Last Verified: March 2009

Keywords provided by St. Antonius Hospital:
pulmonary embolism
pro-BNP
home treatment

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases