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

This study has been completed.
Sponsor:
Collaborators:
Diakonessenhuis, Utrecht
Groene Hart Ziekenhuis
Reinier de Graaf Hospital, Delft
Information provided by:
St. Antonius Hospital
ClinicalTrials.gov Identifier:
NCT00455819
First received: April 3, 2007
Last updated: March 30, 2009
Last verified: March 2009
  Purpose

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 Intervention
Pulmonary Embolism
Procedure: home treatment

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Home Treatment of Patients With Pulmonary Embolism Based on Pro-BNP Levels

Resource links provided by NLM:


Further study details as provided by St. Antonius Hospital:

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

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

Enrollment: 150
Study Start Date: December 2006
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by St. Antonius Hospital

Additional 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
Study First Received: April 3, 2007
Last Updated: March 30, 2009
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

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

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

ClinicalTrials.gov processed this record on October 29, 2014