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

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

Not applicable Interventional Assistance Publique - Hôpitaux de Paris · NCT07315347

This trial will try treating adults with active cancer and a stable pulmonary embolism at home instead of in hospital to see if 14-day results are as safe.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment824 (estimated)
Ages18 Years and up
SexAll
SponsorAssistance Publique - Hôpitaux de Paris Academic / other
Locations20 sites (Colombes, France and 19 other locations)
Trial IDNCT07315347 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18 years) with active cancer and a hemodynamically stable symptomatic or incidental pulmonary embolism confirmed within 24 hours who have no HESTIA criteria and can comply with follow-up are ideal candidates.

Not a fit: Patients with shock or hypotension, other HESTIA criteria, very high-risk PE, recent PE diagnosis >24 hours, or inability to follow outpatient care (including lack of French social-security coverage or language barriers) are unlikely to benefit from home treatment.

Why it matters

Potential benefit: If successful, this approach could allow safe outpatient care for selected cancer patients with PE, reducing hospital stays and improving patient comfort and resource use.

How similar studies have performed: Previous trials like HOME-PE showed that HESTIA-based outpatient triage can be safe for selected PE patients and post hoc analyses suggest home care may be feasible in some cancer patients, but evidence specifically focused on active cancer remains limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Colombes, France and 19 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Active Cancer and Symptomatic or Incidental Pulmonary Embolism Without HESTIA CriteriaActive cancerpulmonary embolismnegative HESTIA rulehome treatment
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.