Home Treatment of Patients With Active Cancer and Acute Pulmonary Embolism Without HESTIA Criteria.
HOME-PEK
3 other identifiers
interventional
824
1 country
20
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2026
Typical duration for not_applicable
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2025
CompletedFirst Posted
Study publicly available on registry
January 2, 2026
CompletedStudy Start
First participant enrolled
February 2, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2029
April 23, 2026
April 1, 2026
3 years
December 18, 2025
April 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of composite primary endpoint
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. To assess the non-inferiority of home treatment as compared to hospitalisation, the rates of the composite primary endpoint, at 14 days, will be compared between the two groups using logistic regression adjusted on stratification factors (symptomatic or incidental PE, type of cancer, localised or metastatic cancer, and centre). Results will be presented as rates difference (home treatment minus hospitalisation), in this sense.
Within 14 days following randomisation
Secondary Outcomes (13)
Key Secondary Endpoint: Change in EQ-5D-5L Index
Inclusion, 7 days, 14 days following randomisation
Safety: Rate of Symptomatic or Incidental Recurrent PE and DVT (Lower Limb, Upper Limb, or Catheter-Related)
7 days, 14 days, 30 days, 90 days following randomisation
Safety: Rate of Major Bleeding
7 days, 14 days, 30 days, 90 days following randomisation
Safety: Rate of Clinically Relevant Non-Major Bleeding
7 days, 14 days, 30 days, 90 days following randomisation
Safety: Rate of All-Cause Mortality
7 days, 14 days, 30 days, 90 days following randomisation
- +8 more secondary outcomes
Study Arms (2)
Home-treatment group
EXPERIMENTALPatients will be discharged home within 24hrs after randomisation.
Hospitalisation group
NO INTERVENTIONPatients 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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).
- Signed informed consent
- Affiliated to French " sécurité sociale "
- Good understanding of the French language
You may not qualify if:
- 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
- Pregnant or breastfeeding women
- Patient on AME (state medical aid)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
C05 - Médecine Interne - Hôpital Louis Mourier - APHP
Colombes, France, 92700, France
C04 - Oncologie Médicale - Centre Georges-François Leclerc - CLCC
Dijon, France, 21079, France
C06 - Pneumologie - Hôpital Cochin - APHP
Paris, France, 75014, France
C01 - Pneumologie et Soins Intensifs - HEGP
Paris, France, 75015, France
C03 - Médecine interne et médecine vasculaire - Hospices Civils de Lyon
Pierre-Bénite, France, 69310, France
C02 - Département interdisciplinaire d'organisation des parcours patients - Institut gustave Roussy
Villejuif, France, 94805, France
C12 - Médecine Vasculaire - CHU Amiens Picardie
Amiens, 80054, France
C10 - Département médecine urgence - CHU Angers
Angers, 49933, France
C08 - Département de Médecine interne et pneumologie - CHU la Cavale Blanche
Brest, 29609, France
C11 - Pneumologie - CH René Dubos
Cergy-Pontoise, 95304, France
C16 - Département Urgences - CHU Clermont Ferrand
Clermont-Ferrand, 63000, France
C13 - Médecine Vasculaire - CHU Dijon
Dijon, 21000, France
C18 - Pneumologie - CH de Versailles Hôpital André Mignot
Le Chesnay, 78157, France
C17 - Médecine Interne - CHU Nantes
Nantes, 44000, France
C07 - Médecine Vasculaire - Hôpital Saint Joseph
Paris, 75014, France
C15 - Médecine Interne - CHU Rouen
Rouen, 76031, France
C09 - Médecine vasculaire et thérapeuthique - CHU Saint Etienne
Saint-Priest-en-Jarez, 42270, France
C19 - Pneumologie - Hôpital Foch
Suresnes, 92151, France
C14 - Médecine Vasculaire - CH Toulon
Toulon, 83100, France
C20 - Médecine Vasculaire - CHU Toulouse
Toulouse, 31059, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Olivier SANCHEZ, MD
Assistance Publique - Hôpitaux de Paris
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2025
First Posted
January 2, 2026
Study Start
February 2, 2026
Primary Completion (Estimated)
February 1, 2029
Study Completion (Estimated)
April 1, 2029
Last Updated
April 23, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Two years after the last publication
- Access Criteria
- Data sharing requires approval from both the sponsor and the principal Investigator (PI), contingent upon a scientific project and the PI team's scientific contribution. The founder may also participate in the decision-making process. Teams seeking to acquire IPD must engage with the sponsor and the IP team to discuss the scientific (and commercial) objectives, the specific IP required, the preferred data transmission format, and the proposed timeline. The necessity to inform patients about data sharing or the obligation to undertake procedures with data protection authorities will be evaluated. The provision of data through the secure institutional tools of the sponsor AP-HP will be prioritized. Technical feasability and financial support considerations will precede the obligatory formalization of a contract, including detailed description of data processing and general and specific security measures. The processing must adhere to the European General Data Portection Regulation
The deindentified individual participant data (IPD) that support the results reported in publications may be shared. Additionally, the IPD outlined in the protocol for a planned meta-analysis may also be made available. A data dictionary defining each field will be made available concurrently with the data transmission.