Active Cancer and Symptomatic or Incidental Pulmonary Embolism Without HESTIA CriteriaHOME-PEKNCT07315347
Home Treatment of Patients With Active Cancer and Acute Pulmonary Embolism Without HESTIA Criteria.
A study testing Home-treatment group in people with Active Cancer and Symptomatic or Incidental Pulmonary Embolism Without HESTIA Criteria, run by Assistance Publique - Hôpitaux de Paris at 20 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Active Cancer and Symptomatic or Incidental Pulmonary Embolism Without HESTIA Criteria
- What is being tested?
- Home-treatment group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 824 participants
- Where
- 20 sitesFrance
- Study dates
- 2 Feb 2026to Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Show all 10Show fewer
- For woman of childbearing potential: negative beta-HCG before inclusion
- Signed informed consent
- Affiliated to French " sécurité sociale "
- Good understanding of the French language
Who cannot join
- 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
Show all 12Show fewer
- 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)
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
20 sites in 1 country
France20 sites, 20 recruiting
- Recruiting
C12 - Médecine Vasculaire - CHU Amiens Picardie
Amiens, 80054
Marie-Antoinette SEVESTRE-PIETRI, MD, 0322087280 ext. +33, sevestre.marie-antoinette@chu-amiens.fr
Marie-Antoinette SEVESTRE-PIETRI, MD
- Recruiting
C10 - Département médecine urgence - CHU Angers
Angers, 49933
Pierre-Marie ROY, MD, 0241353715 ext. +33, pmroy@chu-angers.fr
Pierre-Marie ROY, MD
- Recruiting
C08 - Département de Médecine interne et pneumologie - CHU la Cavale Blanche
Brest, 29609
Francis COUTURAUD, MD, 0298347347 ext. +33, francis.couturaud@chu-brest.fr
Francis COUTURAUD, MD
- Recruiting
C11 - Pneumologie - CH René Dubos
Cergy-Pontoise, 95304
Joëlle HOBEIKA, MD, 0130754306 ext. +33, joelle.hobeika@ght-novo.fr
Joëlle HOBEIKA, MD
- Recruiting
C16 - Département Urgences - CHU Clermont Ferrand
Clermont-Ferrand, 63000
Jeannot SCHMIDT, MD, 0473751556 ext. +33, jschmidt@chu-clermontferrand.fr
Jeannot SCHMIDT, MD
- Recruiting
C05 - Médecine Interne - Hôpital Louis Mourier - APHP
Colombes, France, 92700
Isabelle MAHE, MD, 0147606456 ext. +33, isabelle.mahe@aphp.fr
Isabelle MAHE, MD
- Not yet recruiting
C04 - Oncologie Médicale - Centre Georges-François Leclerc - CLCC
Dijon, France, 21079
Didier MAYEUR, MD, 0383598564 ext. +33, dmayeur@cgfl.fr
Didier MAYEUR, MD
- Not yet recruiting
C13 - Médecine Vasculaire - CHU Dijon
Dijon, 21000
Nicolas FALVO, MD, 0380293358 ext. +33, nicolas.falvo@chu-dijon.fr
Nicolas FALVO, MD
- Recruiting
C18 - Pneumologie - CH de Versailles Hôpital André Mignot
Le Chesnay, 78157
Cécile DUJON, MD, 0139638888 ext. +33, cdujon@ght78sud.fr
Cécile DUJON, MD
- Recruiting
C17 - Médecine Interne - CHU Nantes
Nantes, 44000
Olivier ESPITIA, MD, 0240083355 ext. +33, Olivier.ESPITIA@chu-nantes.fr
Olivier ESPITIA, MD
- Not yet recruiting
C06 - Pneumologie - Hôpital Cochin - APHP
Paris, France, 75014
Marie WISLEZ, MD, 0158412149 ext. +33, marie.wislez@aphp.fr
Marie WISLEZ, MD
- Recruiting
C01 - Pneumologie et Soins Intensifs - HEGP
Paris, France, 75015
Olivier SANCHEZ, MD, 0156093487 ext. +33, olivier.sanchez@aphp.fr
Olivier SANCHEZ, MD
- Not yet recruiting
C07 - Médecine Vasculaire - Hôpital Saint Joseph
Paris, 75014
Joseph EMMERICH, MD, 0144128025 ext. +33, jemmerich@ghpsj.fr
Joseph EMMERICH, MD
- Recruiting
C03 - Médecine interne et médecine vasculaire - Hospices Civils de Lyon
Pierre-Bénite, France, 69310
Stéphane LO, MD, 0478863268 ext. +33, stephane.lo@chu-lyon.fr
Stéphane LO, MD
- Recruiting
C15 - Médecine Interne - CHU Rouen
Rouen, 76031
Sébastien MIRANDA, MD, 0232888990 ext. +33, sebastien.miranda@chu-rouen.fr
Sébastien MIRANDA, MD
- Recruiting
C09 - Médecine vasculaire et thérapeuthique - CHU Saint Etienne
Saint-Priest-en-Jarez, 42270
Laurent BERTOLETTI, MD, 0347782771 ext. +33, laurent.bertoletti@chu-st-etienne.fr
Laurent BERTOLETTI, MD
- Recruiting
C19 - Pneumologie - Hôpital Foch
Suresnes, 92151
Céline GOYARD, MD, 0146253633 ext. +33, c.goyard@hopital-foch.com
Céline GOYARD, MD
- Recruiting
C14 - Médecine Vasculaire - CH Toulon
Toulon, 83100
Jean-Noël POGGI, MD, 0494145955 ext. +33, jean-noel.poggi@ch-toulon.fr
Jean-Noël POGGI, MD
- Not yet recruiting
C20 - Médecine Vasculaire - CHU Toulouse
Toulouse, 31059
Alessandra BURA-RIVIERE, MD, bura-riviere.a@chu-toulouse.fr
Alessandra BURA-RIVIERE, MD
- Recruiting
C02 - Département interdisciplinaire d'organisation des parcours patients - Institut gustave Roussy
Villejuif, France, 94805
Florian SCOTTE, MD, 0142114053 ext. +33, Florian.SCOTTE@gustaveroussy.fr
Florian SCOTTE, MD
About this study
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.
Read more
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.
Read the detailed description
Several studies have demonstrated that patients with low-risk pulmonary embolism (PE), selected on simplified PE Severity Index (sPESI) = 0 or without HESTIA criteria, can be safely treated at home. The HOME-PE study demonstrated that HESTIA rule was at least as safe as sPESI score for triaging patients with PE. With both strategies, almost 35% of patients could be managed at home with a low rate of complications (" 1% at Day-30).
PE is a common complication in patients with cancer who are at higher risk for recurrence of venous thromboembolism (VTE), bleeding and PE-related death than patients without cancer. For these reasons, some decision-making tools categorise all patients with cancer at risk of complications and are therefore not eligible for home treatment. In a post hoc analysis of the HOME-PE trial, the 30-day rate of adverse events was higher in patients with active cancer treated at home (4.3%) than in those without (1.0%), but was comparable in patients with cancer hospitalised only because of cancer (3.0%). Home treatment was not a risk factor of complications among cancer patients. Interestingly, 90% of these complications occurred after day-10 suggesting that hospitalisation did not avoid the occurrence of adverse events. Moreover, approximately 50% of PE in patients with cancer is now incidentally detected on imaging undertaken for cancer staging or evaluation of treatment response with a prevalence up to 5%. These patients should be managed in the same manner as symptomatic PE since they have similar prognosis. However, hospitalisation is sometimes challenging in daily practice (availability of bed…) and some of these patients are currently treated at home despite the absence of evidence on the safety of such management.
Home treatment is important for retaining autonomy of patients and may improve their perception of health and quality of life which are particularly relevant for cancer patients. However, this expected benefit have never been confirmed in a prospective trial.
We propose to assess in a randomised controlled trial whether home treatment of patients with active cancer and symptomatic or incidental PE with a negative HESTIA rule is at least as safe as hospitalisation. Furthermore, we will assess the impact of home treatment on several patient-centred outcomes as well as medico-economic issues.
The results are expected to help to define the best management strategy and will provide high level of evidence for cancer associated PE patient care in terms of safety, efficacy and efficiency.
Included patients will be randomised into two groups (1:1) 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.
Data will be recorded in a computerised case report form (e-CRF) enabling randomisation between home treatment and hospitalisation. In both groups, physicians in charge of the patients will prescribe anticoagulant according to local protocols. Anticoagulant treatment will be started at the latest immediately after PE diagnosis. All patients will be instructed to contact the local thrombosis team or to report to the ED in case of any new symptoms suggestive of VTE or any bleeding episodes occur. Follow-up will occur at 7, 14, 30 and 90 days after inclusion in both groups to gather clinical events (recurrent VTE, major or clinically relevant bleeding, death), patients-centred outcomes (EQ-5D-5L, PEmbQoL, ACTS) and patients resource utilisation. An independent adjudication committee will evaluate all clinical endpoints blinded to the group allocated.
- Being tested
- Home-treatment group
- Keywords
- Active cancer; pulmonary embolism; negative HESTIA rule; home treatment
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-treatment groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Home-treatment group | Experimental | Patients will be discharged home within 24hrs after randomisation. Receives: Other: Home-treatment group |
| Hospitalisation group | No intervention | Patients 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 14 days following randomisation
Secondary outcomes (13)
Key Secondary Endpoint: Change in EQ-5D-5L Index
Change from baseline in EQ-5D-5L index (5 health dimensions) assessed at inclusion, D7 and D14.
The EQ-5D-5L system consists of five dimensions (also called items), each exploring one Health-related dimension among mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension is answered by selecting one of five ordered functional levels (5-levels Likert scale): no problem, slight problems, moderate problems, severe problems, and extreme problems. For each patient, the combination of the five answers corresponds to his/her health state or profile. With the five ordinal levels of each answer encoded 1 to 5 and a total of 3125 possible combinations, "11111" represents full health and "55555" the worst possible health state.
Measured: Inclusion, 7 days, 14 days following randomisation
Safety: Rate of Symptomatic or Incidental Recurrent PE and DVT (Lower Limb, Upper Limb, or Catheter-Related)
The rate of symptomatic or incidental recurrent PE or proximal and/or distal DVT of lower limb or upper limb or catheter-related.
Measured: 7 days, 14 days, 30 days, 90 days following randomisation
Safety: Rate of Major Bleeding
The rate of major bleeding (ISTH definition).
Measured: 7 days, 14 days, 30 days, 90 days following randomisation
Safety: Rate of Clinically Relevant Non-Major Bleeding
The rate of clinically relevant non-major bleeding.
Measured: 7 days, 14 days, 30 days, 90 days following randomisation
Safety: Rate of All-Cause Mortality
The rate of all-cause mortality.
Measured: 7 days, 14 days, 30 days, 90 days following randomisation
Safety: Rate of PE-Related Death
The rate of PE-related death.
Measured: 7 days, 14 days, 30 days, 90 days following randomisation
Safety: Rate of Cancer-Related Death
The rate of cancer-related death.
Measured: 7 days, 14 days, 30 days, 90 days following randomisation
Safety: Rate of Patients Meeting EARTH Criteria
The rate of patients meeting the EARTH criteria, composed by: confirmed new onset of hypoxemia (<90%) requiring oxygen or ventilation support; confirmed new onset of severe hypotension or shock requiring treatment; new confirmed symptomatic cardiac rhythm disorder requiring urgent treatment; symptomatic PE recurrence or symptomatic proximal DVT requiring specific treatment or anticoagulation modification; major bleeding; death possibly related to PE (including death with an unknown cause).
Measured: 7 days, 14 days following randomisation
Quality of Life: EQ-5D-5L and EQ VAS
The EQ-5D-5L system consists of five dimensions, each exploring one Health-related dimension among mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension is answered by selecting one of five ordered functional levels (5-levels Likert scale): no problem, slight problems, moderate problems, severe problems, and extreme problems. For each patient, the combination of the five answers corresponds to his/her health state or profile. It also includes a Visual Analogue Scale (VAS) where patients rate their overall health from 0 (worst) to 100 (best).
Measured: 7 days, 14 days, 30 days, 90 days following randomisation
Quality of Life: PEmbQoL
Patient-reported Pulmonary Embolism Quality of Life (PEmbQoL) PEmbQoL ordinal scores SL (social limitations), Q2, Q3 and PEmbQoL quantitative scores FO (frequency of Complaints), WR (Work related problems), EC (Emotional complaints), ADL (Activity daily limitation), IO (Intensity of Complaints)
Measured: 30 days, 90 days following randomisation
Treatment Satisfaction: Anti-Clot Treatment Scale
Satisfaction measured using the Anti-Clot Treatment Scale Questionnaire. The Anti-Clot Treatment Scale (ACTS) is a 15-item patient-reported instrument of satisfaction with anticoagulant treatment. It includes a 12-item ACTS Burdens scale and a 3-item ACTS Benefits scale.
Measured: 30 days, 90 days following randomisation
Healthcare Resource Utilisation
Mean cumulative hospital length of stay for initial hospitalisation and proportion of patients with unscheduled medical consultations.
Measured: 14 days, 30 days, 90 days following randomisation
Medico-Economic: Cost-Utility and Cost-Effectiveness
Cost-effectiveness within 30 days and 90 days following randomisation.
Measured: 30 days, 90 days following randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start2 Feb 2026
- Primary completionFeb 2029 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Active Cancer and Symptomatic or Incidental Pulmonary Embolism Without HESTIA CriteriaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 824 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Olivier SANCHEZ, MD, Study chair, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07315347
- Sponsor's protocol ID
- APHP241014
- Other IDs
- PHRC-K24-139, 2025-A01173-46
- Acronym
- HOME-PEK
- Status last verified
- Apr 2026
- First submitted
- 18 Dec 2025
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Treatment of Patients With Active Cancer and Acute Pulmonary Embolism Without HESTIA Criteria.
- ClinicalTrials.gov ID
- NCT07315347
- Acronym / sponsor ID
- HOME-PEK / APHP241014
- Keywords
- Active cancer; pulmonary embolism; negative HESTIA rule; home treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 824 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 2 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Several studies have demonstrated that patients with low-risk pulmonary embolism (PE), selected on simplified PE Severity Index (sPESI) = 0 or without HESTIA criteria, can be safely treated at home. The HOME-PE study demonstrated that HESTIA rule was at least as safe as sPESI score for triaging patients with PE. With both strategies, almost 35% of patients could be managed at home with a low rate of complications (" 1% at Day-30).
PE is a common complication in patients with cancer who are at higher risk for recurrence of venous thromboembolism (VTE), bleeding and PE-related death than patients without cancer. For these reasons, some decision-making tools categorise all patients with cancer at risk of complications and are therefore not eligible for home treatment. In a post hoc analysis of the HOME-PE trial, the 30-day rate of adverse events was higher in patients with active cancer treated at home (4.3%) than in those without (1.0%), but was comparable in patients with cancer hospitalised only because of cancer (3.0%). Home treatment was not a risk factor of complications among cancer patients. Interestingly, 90% of these complications occurred after day-10 suggesting that hospitalisation did not avoid the occurrence of adverse events. Moreover, approximately 50% of PE in patients with cancer is now incidentally detected on imaging undertaken for cancer staging or evaluation of treatment response with a prevalence up to 5%. These patients should be managed in the same manner as symptomatic PE since they have similar prognosis. However, hospitalisation is sometimes challenging in daily practice (availability of bed…) and some of these patients are currently treated at home despite the absence of evidence on the safety of such management.
Home treatment is important for retaining autonomy of patients and may improve their perception of health and quality of life which are particularly relevant for cancer patients. However, this expected benefit have never been confirmed in a prospective trial.
We propose to assess in a randomised controlled trial whether home treatment of patients with active cancer and symptomatic or incidental PE with a negative HESTIA rule is at least as safe as hospitalisation. Furthermore, we will assess the impact of home treatment on several patient-centred outcomes as well as medico-economic issues.
The results are expected to help to define the best management strategy and will provide high level of evidence for cancer associated PE patient care in terms of safety, efficacy and efficiency.
Included patients will be randomised into two groups (1:1) 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.
Data will be recorded in a computerised case report form (e-CRF) enabling randomisation between home treatment and hospitalisation. In both groups, physicians in charge of the patients will prescribe anticoagulant according to local protocols. Anticoagulant treatment will be started at the latest immediately after PE diagnosis. All patients will be instructed to contact the local thrombosis team or to report to the ED in case of any new symptoms suggestive of VTE or any bleeding episodes occur. Follow-up will occur at 7, 14, 30 and 90 days after inclusion in both groups to gather clinical events (recurrent VTE, major or clinically relevant bleeding, death), patients-centred outcomes (EQ-5D-5L, PEmbQoL, ACTS) and patients resource utilisation. An independent adjudication committee will evaluate all clinical endpoints blinded to the group allocated.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home-treatment group | Experimental | Other: Home-treatment groupPatients will be discharged home within 24hrs after randomisation. |
| Hospitalisation group | No intervention | –Patients 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (12 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-treatment groupPatients 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. | Other | Home-treatment group |
Primary outcome
Rate of composite primary endpoint
Time frame: Within 14 days following randomisation
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.
13 secondary outcomes
Key Secondary Endpoint: Change in EQ-5D-5L Index
Time frame: Inclusion, 7 days, 14 days following randomisation
Safety: Rate of Symptomatic or Incidental Recurrent PE and DVT (Lower Limb, Upper Limb, or Catheter-Related)
Time frame: 7 days, 14 days, 30 days, 90 days following randomisation
Safety: Rate of Major Bleeding
Time frame: 7 days, 14 days, 30 days, 90 days following randomisation
Safety: Rate of Clinically Relevant Non-Major Bleeding
Time frame: 7 days, 14 days, 30 days, 90 days following randomisation
Safety: Rate of All-Cause Mortality
Time frame: 7 days, 14 days, 30 days, 90 days following randomisation
Safety: Rate of PE-Related Death
Time frame: 7 days, 14 days, 30 days, 90 days following randomisation
Safety: Rate of Cancer-Related Death
Time frame: 7 days, 14 days, 30 days, 90 days following randomisation
Safety: Rate of Patients Meeting EARTH Criteria
Time frame: 7 days, 14 days following randomisation
Quality of Life: EQ-5D-5L and EQ VAS
Time frame: 7 days, 14 days, 30 days, 90 days following randomisation
Quality of Life: PEmbQoL
Time frame: 30 days, 90 days following randomisation
Treatment Satisfaction: Anti-Clot Treatment Scale
Time frame: 30 days, 90 days following randomisation
Healthcare Resource Utilisation
Time frame: 14 days, 30 days, 90 days following randomisation
Medico-Economic: Cost-Utility and Cost-Effectiveness
Time frame: 30 days, 90 days following randomisation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: Yes. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Olivier SANCHEZ, MD study chair
Assistance Publique - Hôpitaux de Paris
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-treatment group in people with Active Cancer and Symptomatic or Incidental Pulmonary Embolism Without HESTIA Criteria, run by Assistance Publique - Hôpitaux de Paris at 20 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cleo BOURGEOIS (+33156095638, cleo.bourgeois@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of composite primary endpoint (time frame: Within 14 days following randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.