Home Treatment of Patients With Pulmonary Embolism Based on Pro-Brain Natriuretic Peptide (BNP) Levels

Pulmonary Embolism Clinical Trial

Official title:

Home Treatment of Patients With Pulmonary Embolism Based on Pro-BNP Levels

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00455819
• Other study ID #: LTME/VL-06.12
• Secondary ID: HOME
• Status: Completed
• Phase: N/A
• First received: April 3, 2007
• Last updated: March 30, 2009
• Start date: December 2006
• Est. completion date: March 2009

Study information

• Verified date: March 2009
• Source: St. Antonius Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

Procedure:
• home treatment

Locations

Country	Name	City	State
Netherlands	St Antonius Hospital	Nieuwegein
Netherlands	Mesos Medical Centre	Utrecht

Sponsors (4)

Lead Sponsor	Collaborator
St. Antonius Hospital	Diakonessenhuis, Utrecht, Groene Hart Ziekenhuis, Reinier de Graaf Hospital, Delft

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality rate due to pulmonary embolism or its treatment during a period of ten days in the outpatient group
Secondary	Rate of re-admission due to pulmonary embolism or its treatment in the outpatient group: hemodynamic instability, major bleeding, recurrence of venous thromboembolism