Home treatment for adults with active cancer and stable pulmonary embolism without HESTIA criteria

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter randomized study that compares early discharge with home treatment to standard hospitalisation for adults with active cancer and a hemodynamically stable symptomatic or incidental pulmonary embolism who do not meet HESTIA criteria. Participants are randomized and stratified by symptomatic versus incidental PE, cancer site, localized versus metastatic disease, and center. The primary outcome is a 14-day composite of recurrent VTE, major or clinically relevant non-major bleeding, and all-cause death, adjudicated centrally. Patients allocated to the home-treatment arm are discharged within 24 hours of randomization and followed for early safety events.

Why it matters

Who can join: the full rules

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's running

• C05 - Médecine Interne - Hôpital Louis Mourier - APHP
  Colombes, France, France Recruiting
• C01 - Pneumologie et Soins Intensifs - HEGP
  Paris, France, France Recruiting
• C03 - Médecine interne et médecine vasculaire - Hospices Civils de Lyon
  Pierre-Bénite, France, France Recruiting
• C02 - Département interdisciplinaire d'organisation des parcours patients - Institut gustave Roussy
  Villejuif, France, France Recruiting
• C12 - Médecine Vasculaire - CHU Amiens Picardie
  Amiens, France Recruiting
• C10 - Département médecine urgence - CHU Angers
  Angers, France Recruiting

Study contacts

• Study coordinator: Cleo BOURGEOIS
• Email: cleo.bourgeois@aphp.fr
• Phone: +33156095638

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.