Home Treatment of Patients With Active Cancer and Acute Pulmonary Embolism Without HESTIA Criteria.
Recruiting · NCT07315347 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- Age ≥ 18 years
- Symptomatic or incidental hemodynamically stable PE objectively confirmed ≤ 24h according to the ESC guidelines
- Active cancer other than basal-cell or squamous-cell carcinoma of the skin defined at least by one of the followings:
- cancer that has been diagnosed within the past 6 months,
- cancer for which anti-cancer treatment is being given at the time of enrolment or during 6 months before randomisation, or recurrent locally advanced or metastatic cancer
- No HESTIA criteria (i.e. no other medical condition than cancer since cancer is one of the medical condition that can check "yes" to the item).
- For woman of childbearing potential: negative beta-HCG before inclusion
- Signed informed consent
- Affiliated to French " sécurité sociale "
- Good understanding of the French language
Exclusion criteria
- Diagnosis of PE established for over 24h before inclusion
- 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
- Hospitalisation for over 24h
- ECOG performans status 3 or 4
- Impossibility for 30-day follow-up,
- Estimated life expectancy less than 30 days
- Patient in detention by judicial or administrative decision,
- Patient placed under a legal protection measure,
- Patient unable of giving free and informed consent
- Inclusion in another interventional study requiring hospitalisation
- Pregnant or breastfeeding women
- Patient on AME (state medical aid)
Where it is running
20 locations listed.
- 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
- C13 - Médecine Vasculaire - CHU Dijon - Dijon, France
- C18 - Pneumologie - CH de Versailles Hôpital André Mignot - Le Chesnay, France
- C17 - Médecine Interne - CHU Nantes - Nantes, France
- C07 - Médecine Vasculaire - Hôpital Saint Joseph - Paris, 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
- C05 - Médecine Interne - Hôpital Louis Mourier - APHP - Colombes, France, France
- C04 - Oncologie Médicale - Centre Georges-François Leclerc - CLCC - Dijon, France, France
- C06 - Pneumologie - Hôpital Cochin - APHP - Paris, France, France
- C01 - Pneumologie et Soins Intensifs - HEGP - Paris, France, France
- C03 - Médecine interne et médecine vasculaire - Hospices Civils de Lyon - Pierre-Bénite, France, France
- C02 - Département interdisciplinaire d'organisation des parcours patients - Institut gustave Roussy - Villejuif, France, France