Pulmonary EmbolismNCT00455819
Home Treatment of Patients With Pulmonary Embolism Based on Pro-Brain Natriuretic Peptide (BNP) Levels
A study testing home treatment in people with Pulmonary Embolism, run by St. Antonius Hospital at 2 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- home treatment
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 2 sitesNetherlands
- Study dates
- Dec 2006to Mar 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- outpatient with a pulmonary embolism, confirmed by locally approved guidelines
- aged 18 years and above
- written informed consent
Who cannot join
- 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
Show all 9Show fewer
- in hospital patients
- physical or psychiatric inability for home treatment
- no support system at home renal insufficiency
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
St Antonius Hospital
Nieuwegein, 3430 EM
Mesos Medical Centre
Utrecht, 3503 RP
About this study
Official title: Home Treatment of Patients With Pulmonary Embolism Based on Pro-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.
Read the 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.
- Conditions
- Pulmonary Embolism
- Being tested
- home treatment
- Keywords
- pulmonary embolism, pro-BNP, home treatment
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
home treatmentProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2007 (estimated)
- Study startDec 2006
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Antonius Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Diakonessenhuis, Utrecht, Groene Hart Ziekenhuis, Reinier de Graaf Groep
- Investigators
- Douwe H Biesma, D.H., Study director, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00455819
- Sponsor's protocol ID
- LTME/VL-06.12
- Other IDs
- HOME
- Status last verified
- Mar 2009
- First submitted
- 3 Apr 2007
- Last updated
- 31 Mar 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20230418
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Treatment of Patients With Pulmonary Embolism Based on Pro-BNP Levels
- ClinicalTrials.gov ID
- NCT00455819
- Acronym / sponsor ID
- LTME/VL-06.12
- Conditions
- Pulmonary Embolism
- Keywords
- pulmonary embolism, pro-BNP, home treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- St. Antonius HospitalUniversity, hospital or other
- Collaborators
- Diakonessenhuis, Utrecht, Groene Hart Ziekenhuis, Reinier de Graaf Groep
- Study start
- Dec 2006
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 4 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- outpatient with a pulmonary embolism, confirmed by locally approved guidelines
- aged 18 years and above
- written informed consent
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| home treatment | Procedure or surgery | – |
Primary outcome
Mortality rate due to pulmonary embolism or its treatment during a period of ten days in the outpatient group
1 secondary outcome
Rate of re-admission due to pulmonary embolism or its treatment in the outpatient group: hemodynamic instability, major bleeding, recurrence of venous thromboembolism
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2009.
- Derived from this study: PubMed 20230418Agterof 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.
Related trials for Pulmonary Embolism
RecruitingObservational study
Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System
Pulmonary Embolism
Not yet recruiting
Pilot Study Evaluating Catheter Directed Thrombolysis Device in Acute Intermediate Risk Pulmonary Embolism
Pulmonary Embolism (PE), Pulmonary Embolism With Right Ventricle Enlargement
RecruitingObservational study
Inari VISION Registry
Pulmonary Embolism
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Douwe H Biesma, D.H. study director
St. Antonius Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing home treatment in people with Pulmonary Embolism, run by St. Antonius Hospital at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality rate due to pulmonary embolism or its treatment during a period of ten days in the outpatient group. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00455819, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2009.