Home Treatment of Patients With Pulmonary Embolism Based on Pro-Brain Natriuretic Peptide (BNP) Levels
2 other identifiers
interventional
150
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2006
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 3, 2007
CompletedFirst Posted
Study publicly available on registry
April 4, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedMarch 31, 2009
March 1, 2009
2.2 years
April 3, 2007
March 30, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mortality rate due to pulmonary embolism or its treatment during a period of ten days in the outpatient group
Secondary Outcomes (1)
Rate of re-admission due to pulmonary embolism or its treatment in the outpatient group: hemodynamic instability, major bleeding, recurrence of venous thromboembolism
Interventions
Eligibility Criteria
You may qualify if:
- outpatient with a pulmonary embolism, confirmed by locally approved guidelines
- aged 18 years and above
- written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- St. Antonius Hospitallead
- Diakonessenhuis, Utrechtcollaborator
- Groene Hart Ziekenhuiscollaborator
- Reinier de Graaf Groepcollaborator
Study Sites (2)
St Antonius Hospital
Nieuwegein, 3430 EM, Netherlands
Mesos Medical Centre
Utrecht, 3503 RP, Netherlands
Related Publications (1)
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.
PMID: 20230418DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Douwe H Biesma, D.H.
St. Antonius Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 3, 2007
First Posted
April 4, 2007
Study Start
December 1, 2006
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
March 31, 2009
Record last verified: 2009-03