Please select the arm or intervention descriptions that belong 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: Arm Label: Intervention; Type: ACTIVE_COMPARATOR; Interventions: Other: Integration of electronic clinical decision support | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Integration of electronic clinical decision support; Assigned to Arm(s): Intervention
B: Arm Label: Outpatient treatment; Type: EXPERIMENTAL; Interventions: Other: Outpatient care (vs traditional inpatient care) | Arm Label: Inpatient care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Outpatient care (vs traditional inpatient care); Assigned to Arm(s): Outpatient treatment
C: Intervention Type: PROCEDURE; Name: home treatment; Assigned to Arm(s): N/A
D: Arm Label: HESTIA group; Type: OTHER; Interventions: Other: HESTIA | Arm Label: sPESI group; Type: OTHER; Interventions: Other: sPESI | Intervention Type: OTHER; Name: HESTIA; Assigned to Arm(s): HESTIA group | Intervention Type: OTHER; Name: sPESI; Assigned to Arm(s): sPESI group

Answer: D