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

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ClinicalTrials.gov Identifier: NCT02811237
Recruitment Status : Recruiting
First Posted : June 23, 2016
Last Update Posted : April 12, 2018
Sponsor:
Collaborators:
European Georges Pompidou Hospital
Hospital Universitario Ramon y Cajal
Leiden University Medical Center
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
University of Lausanne Hospitals
Information provided by (Responsible Party):
University Hospital, Angers

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,

Condition or disease Intervention/treatment Phase
Pulmonary Embolism Other: HESTIA Other: sPESI Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 1975 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official 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)
Actual Study Start Date : January 2017
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.


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.





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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,

  4. Safety endpoints - Recurrent VTE [ Time Frame: 14 days, 30 days, 90 days ]
    The rate of recurrent VTE

  5. Safety endpoints - Suspected recurrent VTE [ Time Frame: 14 days, 30 days, 90 days ]
    The rate of recurrent VTE suspicion

  6. Safety endpoints - Major Bleeding [ Time Frame: 14 days, 30 days, 90 days ]
    The rate of major bleeding

  7. Safety endpoints - Non major bleeding [ Time Frame: 14 days, 30 days, 90 days ]
    The rate of non-major clinically relevant bleeding

  8. Safety endpoints - Death [ Time Frame: 14 days, 30 days, 90 days ]
    The rate of all-cause death

  9. 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

  10. Applicability of management strategies [ Time Frame: 1 day ]
    The rate of patients actually managed as outpatients among number of patientpatients eligible for outpatient management

  11. 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.

  12. 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)


  13. 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).




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02811237


Contacts
Contact: Pierre-Marie ROY, MD.PhD 06 65 80 66 11 PMRoy@chu-angers.fr
Contact: Béatrice GABLE 06 65 80 66 21 begable@chu-angers.fr

Locations
Belgium
Cliniques Universitaires Saint-Luc Recruiting
Brussels, Belgium
Contact: Andréa PENALOZA       andrea.penaloza@uclouvain.be   
Hôpital Erasme Recruiting
Bruxelles, Belgium
Contact: MOTTE Serge       Serge.Motte@erasme.ulb.ac.be   
Hôpital Saint-Pierre Recruiting
Bruxelles, Belgium
Contact: MOLS Pierre       pierre.mols@gmail.com   
CHU de Liège Recruiting
Liege, Belgium
Contact: GHUYSEN Alexandre       a.ghuysen@chu.ulg.ac.be   
Hôpital de Namur Recruiting
Namur, Belgium
Contact: LIEVENS Pascale       pascale.lievens@hotmail.com   
France
Angers University Hospital Recruiting
Angers, France, 49933
Contact: Pierre Marie ROY, MD-PhD    06 65 80 66 11    pmroy@chu-angers.fr   
Hia Brest Recruiting
Brest, France, 29240
Contact: Anne LE COAT       annelecoat@gmail.com   
CHU Brest Recruiting
Brest, France
Contact: Aurélien DELLUC       aurelien.delluc@chu-brest.fr   
Contact: Francis COUTURAUD       francis.couturaud@chu-brest.fr   
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France
Contact: SCHMIDT Jeannot       jschmidt@chu-clermontferrand.fr   
APHP Louis Mourier Recruiting
Colombes, France
Contact: Isabelle MAHE       isabelle.mahe@aphp.fr   
Contact: Nicolas JAVAUD       nicolas.javaud@aphp.fr   
CHU Dijon Recruiting
Dijon, France
Contact: HONNART Didier       didier.honnart@chu-dijon.fr   
Contact: FALVO Nicolas       nicolas.falvo@chu-dijon.fr   
CHU Grenoble Recruiting
Grenoble, France
Contact: Maxime MAIGNAN       MMaignan@chu-grenoble.fr   
Thibault Schotté Recruiting
Le Mans, France
Contact: SCHOTTE Thibault       tschotte@ch-lemans.fr   
Contact: MONTACLAIR Karine       kmontaclair@ch-lemans.fr   
CHU de Montpellier Not yet recruiting
Montpellier, France
Contact: SEBBANE Mustapha       m-sebbane@chu-montpellier.fr   
Contact: QUERE Isabelle       i-quere@chu-montpellier.fr   
APHP Cochin Recruiting
Paris, France
Contact: Florence DUMAS       florence.dumas@aphp.fr   
APHP Hôpital Européen Georges Pompidou Recruiting
Paris, France
Contact: Olivier SANCHEZ, MD.PhD       olivier.sanchez@aphp.fr   
Contact: Anne-Laure FERAL, MD       anne-laure.feral-pierssens@aphp.fr   
APHP Lariboisière Recruiting
Paris, France
Contact: Jean-François BERGMANN       jf.bergmann@aphp.fr   
Contact: Patrick PLAISANCE         
CHU de Rouen Recruiting
Rouen, France
Contact: JOLY Luc-Marie       Luc-Marie.Joly@chu-rouen.fr   
CHU Saint Etienne Not yet recruiting
Saint Etienne, France
Contact: Laurent BERTELOTTI       laurent.bertoletti@gmail.com   
Contact: Alain VIALLON       alain.viallon@chuse.fr   
CH Toulon Recruiting
Toulon, France
Contact: Antoine ELIAS       antoine.elias@free.fr   
CHU Toulouse Recruiting
Toulouse, France
Contact: Alessendra BURA-RIVIERE       bura-riviere.a@chu-toulouse.fr   
Contact: Henry JUCHET       juchet.h@chu-toulouse.fr   
Netherlands
Red Cross Hospital Recruiting
Beverwijk, Netherlands, 1942 LE
Contact: Laura l FABER       lfaber@rkz.nl   
TERGOOI Recruiting
Hilversum, Netherlands, 1213 XZ
Contact: Pieter Wi KAMPHUISEM       pkamphuisem@tergooi.nl   
Leiden University Medical Center Leiden, Recruiting
Leiden, Netherlands
Contact: Menno HUISMAN, MD.PhD       M.V.Huisman@lumc.nl   
Contact: Erik KLOK, MD       F.A.Klok@lumc.nl   
University Medical Center Utrecht Recruiting
Utrecht, Netherlands, 3584 CX
Contact: Mathilde Nijkeuter Nijkeuter       M.Nykeuter@umcutrecht.nl   
Spain
Ramon y Cajal Hospital Not yet recruiting
Madrid, Spain
Contact: David JIMENEZ, MD.PhD       djimenez.hrc@gmail.com   
Switzerland
Hôpital de Genève Not yet recruiting
Geneve, Switzerland
Contact: RIGHINI Marc       Marc.Righini@hcuge.ch   
Hôpital de Lausanne Recruiting
Lausanne, Switzerland
Contact: HUGLI Olivier       Olivier.Hugli@chuv.ch   
Sponsors and Collaborators
University Hospital, Angers
European Georges Pompidou Hospital
Hospital Universitario Ramon y Cajal
Leiden University Medical Center
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
University of Lausanne Hospitals
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 Ramon 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:

Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT02811237     History of Changes
Other Study ID Numbers: PHRC 2015-04
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases