pulmonary embolism blood clots in the lung
Conditions
Interventions
HOME-PE is a randomized controlled randomized multicentre international trial
with non-inferiority analysis for the main safety judgment criterion (rate of
adverse events) and superiority analysis f
pulmonary embolism - triage - home treatment
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Admission to Emergency Department in one of the participating centres; Established pulmonary embolism diagnosis according to the European Society of Cardiology criteria; Insurance cover according to local legislation; Age >=18 years; Orally given or signed informed consent (according to local legislation)
Exclusion criteria
Exclusion criteria: Shock or hypotension defined as systolic blood pressure =40 mmHg, for >15 minutes, if not caused by new-onset arrhythmia, hypovolaemia, or sepsis. Diagnosis of pulmonary embolism established over 24H before inclusion; More than 48h between first presentation to the Emergency unit and inclusion; Impossibility for 30-day follow-up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary safety endpoint: The composite rate of recurrent VTE, major bleeding and death at 30 days following the inclusion: - Recurrent VTE: objectively confirmed pulmonary embolism or deep venous thrombosis objectively confirmed. - Major bleeding: according to the International Society on Thrombosis and Haemostasis* criteria. - Death: all-cause mortality. Primary efficacy endpoints: 1) The rate of *low-risk* patients eligible for outpatient care: - HESTIA group: patients meeting none of the exclusion criteria of the rule (HESTIA rule negative); - sPESI group: patients with a simplified PESI score =0. 2) The rate of patients managed as outpatients defined by patients discharged home within 24 hours after the inclusion in the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Safety endpoints: - The rate of recurrent VTE, - The rate of major bleeding, - All-cause mortality. • Applicability endpoint: - The rate of patients eventually managed as outpatients among patients eligible for outpatient care (i.e. patients meeting all the criteria of the rule in the HESTIA group and patients with a simplified PESI score =0 in the sPESI group). • Resource utilization endpoint: - Mean cumulative hospital length of stay for initial hospitalization and unscheduled hospitalizations in the 30 days following admission. • Patients satisfaction and quality of life: - Patient-reported Pulmonary Embolism Quality of Life Questionnaire and Anti-Clot Treatment Questionnaire at 30 days following inclusion. | — |
Countries
The Netherlands
Outcome results
None listed