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

This study has been completed.

First Received: April 3, 2007 Last Updated: March 30, 2009 History of Changes

Sponsors and Collaborators:	St. Antonius Hospital Diakonnesnhuis utrecht Groene hart Hospital Gouda Reinier de Graaf Hospital, Delft
Information provided by:	St. Antonius Hospital
ClinicalTrials.gov Identifier:	NCT00455819

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:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	Home Treatment of Patients With Pulmonary Embolism Based on Pro-BNP Levels

Resource links provided by NLM:

MedlinePlus related topics: Pulmonary Embolism

U.S. FDA Resources

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

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

Diakonnesnhuis utrecht

Groene hart Hospital Gouda

Reinier de Graaf Hospital, Delft

Investigators

Study Director:

Douwe H Biesma, D.H.

St. Antonius Hospital

More Information

No publications provided

Study ID Numbers:	LTME/VL-06.12, HOME
Study First Received:	April 3, 2007
Last Updated:	March 30, 2009
ClinicalTrials.gov Identifier:	NCT00455819 History of Changes
Health Authority:	Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by St. Antonius Hospital:

pulmonary embolism
pro-BNP
home treatment

Study placed in the following topic categories:

Natriuretic Peptide, Brain
Embolism and Thrombosis
Pulmonary Embolism
Respiratory Tract Diseases
Embolism

Lung Diseases
Vascular Diseases
Cardiovascular Agents
Thrombosis

Additional relevant MeSH terms:

Natriuretic Peptide, Brain
Pulmonary Embolism
Physiological Effects of Drugs
Vascular Diseases
Cardiovascular Agents
Pharmacologic Actions
Embolism and Thrombosis

Respiratory Tract Diseases
Embolism
Natriuretic Agents
Lung Diseases
Therapeutic Uses
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 10, 2009