Hospitalization or Out-treatment ManagEment of Patients With Pulmonary Embolism: a Randomized Controlled Trial

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,

Conditions

• Pulmonary Embolism

Interventions

OTHER

HESTIA

Management based on the HESTIA rule: * If the rule is negative, meaning that patient meet none of the exclusion criteria of the rule, the proposed management will be outpatient care. * In the other cases, the patient will receive in-hospital care. Any reason for management (hospitalization or outpatient treatment) not based on the recommendation will be explained and documented in the e-CRF.

OTHER

sPESI

Management based on the simplified PESI score: * If the sPESI score =0, the proposed management will be outpatient care. * In the other cases, the patient will receive in-hospital care. Any reason for management (hospitalization or outpatient treatment) not based on the recommendation will be explained and documented in the e-CRF.

Sponsors & Collaborators

• European Georges Pompidou Hospital

  collaborator OTHER

• Hospital Universitario Ramon y Cajal

  collaborator OTHER

• Leiden University Medical Center

  collaborator OTHER

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  collaborator OTHER

• University of Lausanne Hospitals

  collaborator OTHER

• University Hospital, Angers

  lead OTHER_GOV

Principal Investigators

• Pierre-Marie ROY, MD.PhD · CHU d'Angers, France

• Olivier SANCHEZ, MD.PhD · APHP Hôpital Européen Georges Pompidou, Paris, France

• Menno HUISMAN, MD.PhD · Leiden University Medical Center, Leiden, The Netherlands

• David JIMENEZ, MD.PhD · Hospital Universitario Ramon y Cajal, Madrid, Spain

• Andréa PENALOZA, MD.PhD · Clinique Unisersitaire Saint Luc, Brussels, Belgium

• Guy MEYER, MD.PhD · APHP Hôpital Européen Georges Pompidou, Paris, France

• EriK KLOK, MD · Leiden University Medical Center Leiden, the Netherlands

• Olivier HUGLI · Centre Hospitalier Universitaire Vaudois

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-01-31

Primary Completion

2019-07-31

Completion

2019-10-30

Countries

• Belgium
• France
• Netherlands
• Spain
• Switzerland

Study Locations