NCT Number: NCT00455819
Home Treatment of Patients With Pulmonary Embolism Based on Pro-Brain Natriuretic Peptide (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.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
St Antonius Hospital, Nieuwegein, Netherlands
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Mortality rate due to pulmonary embolism or its treatment during a period of ten days in the outpatient group
Secondary outcomes
-
Rate of re-admission due to pulmonary embolism or its treatment in the outpatient group: hemodynamic instability, major bleeding, recurrence of venous thromboembolism
Sponsors and collaborators
Lead sponsor
St. Antonius Hospital
Other
Collaborators
- Diakonessenhuis, Utrecht
- Groene Hart Ziekenhuis
- Reinier de Graaf Groep
Registry information
Official study title
Home Treatment of Patients With Pulmonary Embolism Based on Pro-BNP Levels
Important dates
- Study start
- 2006
- Primary completion
- 2009
- Study completion
- 2009
- First posted
- Apr 4, 2007
- Registry last updated
- Mar 31, 2009
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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