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NOT YET RECRUITING
NCT07315347
NA

Home Treatment of Patients With Active Cancer and Acute Pulmonary Embolism Without HESTIA Criteria. A Randomised Trial

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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

OTHER

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