Back to resultsHome Treatment of Patients With Pulmonary Embolism Based on Pro-Brain Natriuretic Peptide (BNP) Levels
Primary Purpose
Pulmonary Embolism
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
home treatment
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Embolism focused on measuring pulmonary embolism, pro-BNP, home 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
Sites / Locations
- St Antonius Hospital
- Mesos Medical Centre
Outcomes
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
Full Information
NCT ID
NCT00455819
First Posted
April 3, 2007
Last Updated
March 30, 2009
Sponsor
St. Antonius Hospital
Collaborators
Diakonessenhuis, Utrecht, Groene Hart Ziekenhuis, Reinier de Graaf Hospital, Delft
1. Study Identification
Unique Protocol Identification Number
NCT00455819
Brief Title
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
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
St. Antonius Hospital
Collaborators
Diakonessenhuis, Utrecht, Groene Hart Ziekenhuis, Reinier de Graaf Hospital, Delft
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism
Keywords
pulmonary embolism, pro-BNP, home treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
home treatment
Primary Outcome Measure Information:
Title
Mortality rate due to pulmonary embolism or its treatment during a period of ten days in the outpatient group
Secondary Outcome Measure Information:
Title
Rate of re-admission due to pulmonary embolism or its treatment in the outpatient group: hemodynamic instability, major bleeding, recurrence of venous thromboembolism
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douwe H Biesma, D.H.
Organizational Affiliation
St. Antonius Hospital
Official's Role
Study Director
Facility Information:
Facility Name
St Antonius Hospital
City
Nieuwegein
ZIP/Postal Code
3430 EM
Country
Netherlands
Facility Name
Mesos Medical Centre
City
Utrecht
ZIP/Postal Code
3503 RP
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
20230418
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.
Results Reference
derived
Learn more about this trial
Home Treatment of Patients With Pulmonary Embolism Based on Pro-Brain Natriuretic Peptide (BNP) Levels
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