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

October 30, 2019 updated by: University Hospital, Angers

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)

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,

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All patients admitted in the Emergency Department of the participating centres and diagnosed with PE will be eligible and assessed for potential inclusion.

Included patients will be randomized into two groups (1:1) and stratified by centre. Data will be recorded in a computerized case report form (e-CRF) enabling the randomization.

The HESTIA group will receive outpatient care proposal based on HESTIA criteria. The sPESI group will receive outpatient care proposal based on the simplified PESI score. Any reason for management (hospitalization or outpatient treatment) not based on the recommendation will be explained and documented in the e-CRF.

Follow-up will occur within 72 hours after inclusion, at 14 days, 1 month, and 3 months in both groups to gather clinical event data (recurrent VTE, major bleeding, death), treatment data, unscheduled hospitalizations and patient satisfaction assessment results.

The major objectives will test HESTIA based strategy versus sPESI based strategy in a hierarchical approach:

  • step 1: non-inferiority analysis on the rate of adverse events,
  • if yes, step 2: superiority analysis on the rate of patients managed as outpatients,
  • if yes, step3: superiority analysis on the rate of patients, in theory, eligible for outpatient care.

Study Type

Interventional

Enrollment (Actual)

1975

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium
        • Cliniques Universitaires Saint-Luc
      • Bruxelles, Belgium
        • Hôpital Erasme
      • Bruxelles, Belgium
        • Hôpital Saint-Pierre
      • Liege, Belgium
        • CHU de Liège
      • Namur, Belgium
        • Hôpital de Namur
  • France
      • Angers, France, 49933
        • Angers University hospital
      • Brest, France
        • CHU Brest
      • Brest, France, 29240
        • HIA Brest
      • Clermont-Ferrand, France
        • CHU clermont-ferrand
      • Colombes, France
        • APHP Louis Mourier
      • Dijon, France
        • CHU Dijon
      • Grenoble, France
        • CHU Grenoble
      • Le Mans, France
        • Thibault Schotté
      • Montpellier, France
        • CHU de Montpellier
      • Paris, France
        • APHP Cochin
      • Paris, France
        • APHP Hopital Européen Georges Pompidou
      • Paris, France
        • APHP Lariboisière
      • Rouen, France
        • CHU de Rouen
      • Saint Etienne, France
        • CHU Saint Etienne
      • Toulon, France
        • CH Toulon
      • Toulouse, France
        • CHU Toulouse
  • Netherlands
      • Beverwijk, Netherlands, 1942 LE
        • Red Cross Hospital
      • Hilversum, Netherlands, 1213 XZ
        • Tergooi
      • Leiden, Netherlands
        • Leiden University Medical Center Leiden,
      • Utrecht, Netherlands, 3584 CX
        • University Medical Center Utrecht
  • Spain
      • Madrid, Spain
        • Ramón y Cajal Hospital
  • Switzerland
      • Geneve, Switzerland
        • Hôpital de Genève
      • Lausanne, Switzerland
        • Hôpital de Lausanne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: HESTIA group
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 group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of the composite of recurrent VTE, major bleeding and all cause death at 30 days
Time Frame: 30 days
  • 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.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of patients actually managed as outpatients (meaning patients discharged home within 24 hours after the inclusion in the study (first major secondary objective))
Time Frame: 1 day
The rate of patients managed as outpatients defined by patients discharged home within 24 hours after the inclusion in the study.
1 day
The rate of "low-risk" patients in theory eligible for outpatient care (second major secondary objective)
Time Frame: 1 day

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.
1 day
Safety endpoints - Rate of cumulative events
Time Frame: 14 days, 30 days, 90 days
The rate of the composite of recurrent VTE, major bleeding and all-cause death,
14 days, 30 days, 90 days
Safety endpoints - Recurrent VTE
Time Frame: 14 days, 30 days, 90 days
The rate of recurrent VTE
14 days, 30 days, 90 days
Safety endpoints - Suspected recurrent VTE
Time Frame: 14 days, 30 days, 90 days
The rate of recurrent VTE suspicion
14 days, 30 days, 90 days
Safety endpoints - Major Bleeding
Time Frame: 14 days, 30 days, 90 days
The rate of major bleeding
14 days, 30 days, 90 days
Safety endpoints - Non major bleeding
Time Frame: 14 days, 30 days, 90 days
The rate of non-major clinically relevant bleeding
14 days, 30 days, 90 days
Safety endpoints - Death
Time Frame: 14 days, 30 days, 90 days
The rate of all-cause death
14 days, 30 days, 90 days
Safety endpoints - Serious adverse event
Time Frame: 14 days, 30 days, 90 days
The rate of serious adverse event as defined in good clinical practice
14 days, 30 days, 90 days
Applicability of management strategies
Time Frame: 1 day
The rate of patients actually managed as outpatients among number of patientpatients eligible for outpatient management
1 day
Resources utilization
Time Frame: Day 90
Resources utilization will be assessed via the cumulative in-hospital length of stay (LOS) defined as the LOS for initial hospitalization plus LOS of possible unscheduled hospitalizations in the 30 days and 3 months following admission.
Day 90
Patient satisfaction with care
Time Frame: 30 days

A specific questionnaire will be used at 30 days following inclusion:

- Anti-Clot Treatment - Specific Questionnaire (ACTS)
30 days
Patient quality of life
Time Frame: 30 days

A specific questionnaire will be used at 30 days following inclusion:

- Patient-reported Pulmonary Embolism Quality of Life Questionnaire (PEmb-QoL).
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Collaborators

Cliniques universitaires Saint-Luc- Université Catholique de Louvain
University of Lausanne Hospitals
Hospital Universitario Ramon y Cajal
Leiden University Medical Center
European Georges Pompidou Hospital

Investigators

  • Principal Investigator: Pierre-Marie ROY, MD.PhD, CHU d'Angers, France
  • Principal Investigator: Olivier SANCHEZ, MD.PhD, APHP Hôpital Européen Georges Pompidou, Paris, France
  • Principal Investigator: Menno HUISMAN, MD.PhD, Leiden University Medical Center, Leiden, The Netherlands
  • Principal Investigator: David JIMENEZ, MD.PhD, Hospital Universitario Ramón y Cajal, Madrid, Spain
  • Principal Investigator: Andréa PENALOZA, MD.PhD, Clinique Unisersitaire Saint Luc, Brussels, Belgium
  • Study Chair: Guy MEYER, MD.PhD, APHP Hôpital Européen Georges Pompidou, Paris, France
  • Principal Investigator: EriK KLOK, MD, Leiden University Medical Center Leiden, the Netherlands
  • Principal Investigator: Olivier HUGLI, Centre Hospitalier Universitaire Vaudois

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

July 1, 2019

Study Completion (Actual)

October 30, 2019

Study Registration Dates

First Submitted

June 7, 2016

First Submitted That Met QC Criteria

June 20, 2016

First Posted (Estimate)

June 23, 2016

Study Record Updates

Last Update Posted (Actual)

November 1, 2019

Last Update Submitted That Met QC Criteria

October 30, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHRC 2015-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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