Hospitalization or Outpatient ManagEment of patients with Pulmonary Embolism: a randomized controlled trial - HOME-PE<br>
Phase 3
Completed
- Conditions
- pulmonary embolism blood clots in the lung10014523
- Registration Number
- NL-OMON45665
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 194
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
Shock or hypotension defined as systolic blood pressure <90 mmHg or a systolic pressure drop by >=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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary safety endpoint:<br /><br>The composite rate of recurrent VTE, major bleeding and death at 30 days<br /><br>following the inclusion:<br /><br>- Recurrent VTE: objectively confirmed pulmonary embolism or deep venous<br /><br>thrombosis objectively confirmed.<br /><br>- Major bleeding: according to the International Society on Thrombosis and<br /><br>Haemostasis* criteria.<br /><br>- Death: all-cause mortality.<br /><br><br /><br>Primary efficacy endpoints:<br /><br>1) The rate of *low-risk* patients eligible for outpatient care:<br /><br>- HESTIA group: patients meeting none of the exclusion criteria of the rule<br /><br>(HESTIA rule negative);<br /><br>- sPESI group: patients with a simplified PESI score =0.<br /><br>2) The rate of patients managed as outpatients defined by patients discharged<br /><br>home within 24 hours after the inclusion in the study.</p><br>
- Secondary Outcome Measures
Name Time Method <p>• Safety endpoints:<br /><br>- The rate of recurrent VTE,<br /><br>- The rate of major bleeding,<br /><br>- All-cause mortality.<br /><br>• Applicability endpoint:<br /><br>- The rate of patients eventually managed as outpatients among patients<br /><br>eligible for outpatient care (i.e. patients meeting all the criteria of the<br /><br>rule in the HESTIA group and patients with a simplified PESI score =0 in the<br /><br>sPESI group).<br /><br>• Resource utilization endpoint:<br /><br>- Mean cumulative hospital length of stay for initial hospitalization and<br /><br>unscheduled hospitalizations in the 30 days following admission.<br /><br>• Patients satisfaction and quality of life:<br /><br>- Patient-reported Pulmonary Embolism Quality of Life Questionnaire and<br /><br>Anti-Clot Treatment Questionnaire at 30 days following inclusion.</p><br>