Pulmonary Embolism Clinical Trial
Official title:
Home Treatment of Patients With Pulmonary Embolism Based on Pro-BNP Levels
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 |
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.
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Netherlands | St Antonius Hospital | Nieuwegein | |
Netherlands | Mesos Medical Centre | Utrecht |
Lead Sponsor | Collaborator |
---|---|
St. Antonius Hospital | Diakonessenhuis, Utrecht, Groene Hart Ziekenhuis, Reinier de Graaf Hospital, Delft |
Netherlands,
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 |
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