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Home Treatment of Patients With Active Cancer and Acute Pulmonary Embolism Without HESTIA Criteria. A Randomised Trial
Sponsor: Assistance Publique - Hôpitaux de Paris
Summary
Main objective of this multisite randomised study aims to demonstrate in patients with active cancer and symptomatic or incidental PE without HESTIA criteria, that home treatment is non-inferior to hospitalisation as regards the 14-day rate of the composite primary endpoint. Primary endpoint corresponds to the rate of the composite of centrally adjudicated recurrent incidental or symptomatic VTE (i.e. non fatal or fatal PE, proximal and/or distal deep venous thrombosis (DVT) of lower limb or upper limb or catheter-related thrombosis), major or clinically relevant non-major bleeding and all-cause death within 14 days following randomisation. This composite endpoint represents the net clinical benefit of outpatient care. Included patients will be randomised into two groups and stratified according to symptomatic or incidental PE, site of cancer, localised or metastatic cancer and centre. Patients randomised to the home-treatment group will be discharged home within 24hrs after randomisation. Patients will be contacted by the local thrombosis team by phone within 7 days following inclusion. Patients randomised to the hospitalisation group will be admitted in the hospital during at least 48hrs after randomisation. After this time, physicians in charge of the patients will be free to discharge the patients.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
824
Start Date
2026-01
Completion Date
2029-03
Last Updated
2026-01-02
Healthy Volunteers
No
Interventions
Home-treatment group
Patients randomised to the home-treatment group will be discharged home within 24hrs after randomisation. Patients will be contacted by the local thrombosis team by phone within 7 days following inclusion.
Locations (20)
C12 - Médecine Vasculaire - CHU Amiens Picardie
Amiens, France
C10 - Département médecine urgence - CHU Angers
Angers, France
C08 - Département de Médecine interne et pneumologie - CHU la Cavale Blanche
Brest, France
C11 - Pneumologie - CH René Dubos
Cergy-Pontoise, France
C16 - Département Urgences - CHU Clermont Ferrand
Clermont-Ferrand, France
C05 - Médecine Interne - Hôpital Louis Mourier - APHP
Colombes, France
C13 - Médecine Vasculaire - CHU Dijon
Dijon, France
C04 - Oncologie Médicale - Centre Georges-François Leclerc - CLCC
Dijon, France
C18 - Pneumologie - CH de Versailles Hôpital André Mignot
Le Chesnay, France
C17 - Médecine Interne - CHU Nantes
Nantes, France
C06 - Pneumologie - Hôpital Cochin - APHP
Paris, France
C07 - Médecine Vasculaire - Hôpital Saint Joseph
Paris, France
C01 - Pneumologie et Soins Intensifs - HEGP
Paris, France
C03 - Médecine interne et médecine vasculaire - Hospices Civils de Lyon
Pierre-Bénite, France
C15 - Médecine Interne - CHU Rouen
Rouen, France
C09 - Médecine vasculaire et thérapeuthique - CHU Saint Etienne
Saint-Priest-en-Jarez, France
C19 - Pneumologie - Hôpital Foch
Suresnes, France
C14 - Médecine Vasculaire - CH Toulon
Toulon, France
C20 - Médecine Vasculaire - CHU Toulouse
Toulouse, France
C02 - Département interdisciplinaire d'organisation des parcours patients - Institut gustave Roussy
Villejuif, France