Please select the eligibility criteria that correspond to the clinical trial below.
Title: Criteria for Hospitalization or Outpatient Management of Patients With Pulmonary Embolism, Hestia Rule Versus Simplified PESI Score : an Open-label Controlled Randomized International Trial (HOME-PE)
Brief Summary: Several studies have demonstrated the possibility of outpatient management or early discharge for certain patients presenting acute pulmonary embolism (PE), providing a suitable structure is in place.

The approach featured in the most recent guidelines on acute PE of the European Society of Cardiology, refers to an all-cause mortality risk assessment using the Pulmonary Embolism Severity Index (PESI) score or the simplified PESI score (sPESI). The sPESI takes into account demographics (age), patient history (cancer, cardiac or respiratory disease), and clinical data (systolic blood pressure, heart rate, oxygen saturation). Outpatient care is offered to low-risk patients, providing that all the conditions pertaining to start anticoagulant treatment and follow-up at home are met.

An alternative approach based on a list of simple criteria has been developed as the one used in HESTIA study. The main criteria included in the HESTIA rule consist of absence of the following: hemodynamic instability, need for oxygen therapy, high-risk of hemorrhage, renal or liver failure, or other medical or social conditions requiring hospitalization.

The investigators hereby propose comparing these two approaches in an open-label, controlled randomized international trial with blinded adjudication of endpoints.

The main objective is to demonstrate, in normotensive PE patients, that a strategy based on the HESTIA rule compared to a strategy based on the simplified PESI score is at least as safe as regards the 30-day-rate of adverse events (recurrent VTE, major bleeding or death).

The major secondary objectives are to demonstrate, in normotensive PE patients, that a strategy based on the HESTIA rule compared to a strategy based on the simplified PESI score is more effective :

* As regards the rate of patients eventually managed as outpatients.
* As regards the rate of patients, in theory, eligible for outpatient care,


Options:
A: Inclusion Criteria:

* Acute objectively-confirmed pulmonary embolism, diagnosed in the emergency department

Exclusion Criteria:

* Comfort-care only
* Left the ED against medical advice
* Current PE radiologically diagnosed \>12 hrs prior to arrival
* Recent DVT or PE diagnosed within 30 days
* Pregnant
B: Inclusion Criteria:

* age \>18 years
* objectively confirmed diagnosis of pulmonary embolism
* patients at low-risk (Pulmonary Embolism Severity Index score \<=85)

Exclusion Criteria:

* patients at high-risk (Pulmonary Embolism Severity Index score \>85)
* presence of hypoxemia (arterial SO2 \<90% measured by pulse oximetry or an paO2 on room air of \<60 mm Hg measured by blood gas analysis)
* systolic blood pressure of \<100 mm Hg
* chest pain necessitating parenteral opioid administration
* active bleeding or at high-risk of major bleeding (stroke during the preceding 10 days, gastrointestinal bleeding during the preceding 14 days, or platelets \<75,000 per mm3)
* renal failure (creatinine clearance of \<30 ml/minute based on the Cockcroft-Gault formula)
* body mass \>150 kg
* history of HIT or allergy to heparins
* therapeutic oral anticoagulation (INR ≥2)at the time of pulmonary embolism diagnosis
* potential barriers to treatment adherence or follow-up (alcoholism, illicit current or recent drug use, psychosis, dementia, homelessness, lack of telephone access, transportation time to nearest ED \>45 minutes)
* known pregnancy
* imprisonment
* diagnosis of pulmonary embolism \>23 hours ago
* refusal or inability to provide informed consent
* prior enrollment in the study
C: 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
D: Inclusion Criteria:

* Admission to Emergency Department or unscheduled consultation in one of the participating centres;
* Symptomatic pulmonary embolism objectively confirmed according to the European Society of Cardiology criteria
* Insurance cover according to local legislation;
* Age ≥18 years;
* Free 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 more than 24H before inclusion;
* More than 48h between first presentation to the Emergency unit and inclusion - - Factors rendering 30-day follow-up impossible;

Answer: D