Clinical trial NCT00455819: Home Treatment of Patients With Pulmonary Embolism Based on Pro-Brain Natriuretic Peptide (BNP) Levels
Official title: Home Treatment of Patients With Pulmonary Embolism Based on Pro-BNP Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Embolism
Keywords: pulmonary embolism
pro-BNP
home treatment
Lead sponsor: St. Antonius Hospital
Sponsor class: OTHER
Collaborators: name: Diakonessenhuis, Utrecht
name: Groene Hart Ziekenhuis
name: Reinier de Graaf Groep
First posted: 2007-04-04
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Mortality rate due to pulmonary embolism or its treatment during a period of ten days in the outpatient group
Secondary outcomes:
measure: Rate of re-admission due to pulmonary embolism or its treatment in the outpatient group: hemodynamic instability, major bleeding, recurrence of venous thromboembolism
Other outcomes:
Locations:
city: Nieuwegein
country: Netherlands
facility: St Antonius Hospital
city: Utrecht
country: Netherlands
facility: Mesos Medical Centre
Study officials:
affiliation: St. Antonius Hospital
name: Douwe H Biesma, D.H.
role: STUDY_DIRECTOR
References:
citation: Agterof MJ, Schutgens RE, Snijder RJ, Epping G, Peltenburg HG, Posthuma EF, Hardeman JA, van der Griend R, Koster T, Prins MH, Biesma DH. Out of hospital treatment of acute pulmonary embolism in patients with a low NT-proBNP level. J Thromb Haemost. 2010 Jun;8(6):1235-41. doi: 10.1111/j.1538-7836.2010.03831.x. Epub 2010 Mar 3.