Pulmonary EmbolismHOME-PENCT02811237
Hospitalization or Out-treatment ManagEment of Patients With Pulmonary Embolism: a Randomized Controlled Trial
A study testing HESTIA and sPESI in people with Pulmonary Embolism, run by University Hospital, Angers at 28 sites in 5 countries.
Trial summary
Several studies have demonstrated the possibility of outpatient management or early discharge for certain patients presenting acute pulmonary embolism (PE), providing a suitable structure is in place. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- HESTIA and sPESI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,975 participants
- Where
- 28 sitesin 5 countries
- Study dates
- Jan 2017to 30 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Admission to Emergency Department or unscheduled consultation in one of the participating centres;
- Symptomatic pulmonary embolism objectively confirmed according to the European Society of Cardiology criteria
- Insurance cover according to local legislation;
- Age ≥18 years;
- Free informed consent according to local legislation
Who cannot join
- 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;
- Diagnosis of pulmonary embolism established more than 24H before inclusion;
- More than 48h between first presentation to the Emergency unit and inclusion - - Factors rendering 30-day follow-up impossible;
Trial locations and contacts
28 sites in 5 countries.
28 sites in 5 countries
France16 sites
Angers University Hospital
Angers, 49933
Hia Brest
Brest, 29240
CHU Brest
Brest
CHU Clermont-Ferrand
Clermont-Ferrand
APHP Louis Mourier
Colombes
CHU Dijon
Dijon
CHU Grenoble
Grenoble
Thibault Schotté
Le Mans
CHU de Montpellier
Montpellier
APHP Cochin
Paris
APHP Hôpital Européen Georges Pompidou
Paris
APHP Lariboisière
Paris
CHU de Rouen
Rouen
CHU Saint Etienne
Saint-Etienne
CH Toulon
Toulon
CHU Toulouse
Toulouse
Belgium5 sites
Cliniques Universitaires Saint-Luc
Brussels
Hôpital Erasme
Brussels
Hôpital Saint-Pierre
Brussels
CHU de Liège
Liège
Hôpital de Namur
Namur
Netherlands4 sites
Red Cross Hospital
Beverwijk, 1942 LE
TERGOOI
Hilversum, 1213 XZ
Leiden University Medical Center Leiden,
Leiden
University Medical Center Utrecht
Utrecht, 3584 CX
About this study
Official title: Criteria for Hospitalization or Outpatient Management of Patients With Pulmonary Embolism, Hestia Rule Versus Simplified PESI Score : an Open-label Controlled Randomized International Trial (HOME-PE)
Several studies have demonstrated the possibility of outpatient management or early discharge for certain patients presenting acute pulmonary embolism (PE), providing a suitable structure is in place.
The approach featured in the most recent guidelines on acute PE of the European Society of Cardiology, refers to an all-cause mortality risk assessment using the Pulmonary Embolism Severity Index (PESI) score or the simplified PESI score (sPESI). The sPESI takes into account demographics (age), patient history (cancer, cardiac or respiratory disease), and clinical data (systolic blood pressure, heart rate, oxygen saturation). Outpatient care is offered to low-risk patients, providing that all the conditions pertaining to start anticoagulant treatment and follow-up at home are met.
Read more
An alternative approach based on a list of simple criteria has been developed as the one used in HESTIA study. The main criteria included in the HESTIA rule consist of absence of the following: hemodynamic instability, need for oxygen therapy, high-risk of hemorrhage, renal or liver failure, or other medical or social conditions requiring hospitalization.
The investigators hereby propose comparing these two approaches in an open-label, controlled randomized international trial with blinded adjudication of endpoints.
The main objective is to demonstrate, in normotensive PE patients, that a strategy based on the HESTIA rule compared to a strategy based on the simplified PESI score is at least as safe as regards the 30-day-rate of adverse events (recurrent VTE, major bleeding or death).
The major secondary objectives are to demonstrate, in normotensive PE patients, that a strategy based on the HESTIA rule compared to a strategy based on the simplified PESI score is more effective :
- As regards the rate of patients eventually managed as outpatients.
- As regards the rate of patients, in theory, eligible for outpatient care,
Read the detailed description
All patients admitted in the Emergency Department of the participating centres and diagnosed with PE will be eligible and assessed for potential inclusion.
Included patients will be randomized into two groups (1:1) and stratified by centre. Data will be recorded in a computerized case report form (e-CRF) enabling the randomization.
The HESTIA group will receive outpatient care proposal based on HESTIA criteria. The sPESI group will receive outpatient care proposal based on the simplified PESI score. Any reason for management (hospitalization or outpatient treatment) not based on the recommendation will be explained and documented in the e-CRF.
Follow-up will occur within 72 hours after inclusion, at 14 days, 1 month, and 3 months in both groups to gather clinical event data (recurrent VTE, major bleeding, death), treatment data, unscheduled hospitalizations and patient satisfaction assessment results.
The major objectives will test HESTIA based strategy versus sPESI based strategy in a hierarchical approach:
- step 1: non-inferiority analysis on the rate of adverse events,
- if yes, step 2: superiority analysis on the rate of patients managed as outpatients,
- if yes, step3: superiority analysis on the rate of patients, in theory, eligible for outpatient care.
- Conditions
- Pulmonary Embolism
- Being tested
- HESTIA, sPESI
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HESTIAOther
Management based on the HESTIA rule:
- If the rule is negative, meaning that patient meet none of the exclusion criteria of the rule, the proposed management will be outpatient care.
- In the other cases, the patient will receive in-hospital care.
Any reason for management (hospitalization or outpatient treatment) not based on the recommendation will be explained and documented in the e-CRF.
sPESIOther
Management based on the simplified PESI score:
- If the sPESI score =0, the proposed management will be outpatient care.
- In the other cases, the patient will receive in-hospital care.
Any reason for management (hospitalization or outpatient treatment) not based on the recommendation will be explained and documented in the e-CRF.
| Study group | Role | What they receive |
|---|---|---|
| HESTIA group | Other | Not described Receives: Other: HESTIA |
| sPESI group | Other | Not described Receives: Other: sPESI |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of the composite of recurrent VTE, major bleeding and all cause death at 30 days
- Recurrent VTE: objectively confirmed pulmonary embolism or deep venous thrombosis objectively confirmed.
- Major bleeding: according to the International Society on Thrombosis and Haemostasis' criteria.
- Death: all-cause mortality.
Measured: 30 days
Secondary outcomes (13)
The rate of patients actually managed as outpatients (meaning patients discharged home within 24 hours after the inclusion in the study (first major secondary objective))
The rate of patients managed as outpatients defined by patients discharged home within 24 hours after the inclusion in the study.
Measured: 1 day
The rate of "low-risk" patients in theory eligible for outpatient care (second major secondary objective)
The rate of "low-risk" patients eligible for outpatient care:
- HESTIA group: patients meeting none of the exclusion criteria of the rule (HESTIA rule negative);
- sPESI group: patients with a simplified PESI score =0.
Measured: 1 day
Safety endpoints - Rate of cumulative events
The rate of the composite of recurrent VTE, major bleeding and all-cause death,
Measured: 14 days, 30 days, 90 days
Safety endpoints - Recurrent VTE
The rate of recurrent VTE
Measured: 14 days, 30 days, 90 days
Safety endpoints - Suspected recurrent VTE
The rate of recurrent VTE suspicion
Measured: 14 days, 30 days, 90 days
Safety endpoints - Major Bleeding
The rate of major bleeding
Measured: 14 days, 30 days, 90 days
Safety endpoints - Non major bleeding
The rate of non-major clinically relevant bleeding
Measured: 14 days, 30 days, 90 days
Safety endpoints - Death
The rate of all-cause death
Measured: 14 days, 30 days, 90 days
Safety endpoints - Serious adverse event
The rate of serious adverse event as defined in good clinical practice
Measured: 14 days, 30 days, 90 days
Applicability of management strategies
The rate of patients actually managed as outpatients among number of patientpatients eligible for outpatient management
Measured: 1 day
Resources utilization
Resources utilization will be assessed via the cumulative in-hospital length of stay (LOS) defined as the LOS for initial hospitalization plus LOS of possible unscheduled hospitalizations in the 30 days and 3 months following admission.
Measured: Day 90
Patient satisfaction with care
A specific questionnaire will be used at 30 days following inclusion:
- Anti-Clot Treatment - Specific Questionnaire (ACTS)
Measured: 30 days
Patient quality of life
A specific questionnaire will be used at 30 days following inclusion:
- Patient-reported Pulmonary Embolism Quality of Life Questionnaire (PEmb-QoL).
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study startJan 2017
- Primary completionJul 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,975 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Collaborators
- European Georges Pompidou Hospital, Hospital Universitario Ramon y Cajal, Leiden University Medical Center, Cliniques universitaires Saint-Luc- Université Catholique de Louvain, University of Lausanne Hospitals
- Responsible party
- Sponsor
- Investigators
- Pierre-Marie ROY, MD.PhD, Principal investigator, CHU d'Angers, FranceOlivier SANCHEZ, MD.PhD, Principal investigator, APHP Hôpital Européen Georges Pompidou, Paris, FranceMenno HUISMAN, MD.PhD, Principal investigator, Leiden University Medical Center, Leiden, The NetherlandsDavid JIMENEZ, MD.PhD, Principal investigator, Hospital Universitario Ramon y Cajal, Madrid, SpainAndréa PENALOZA, MD.PhD, Principal investigator, Clinique Unisersitaire Saint Luc, Brussels, BelgiumGuy MEYER, MD.PhD, Study chair, APHP Hôpital Européen Georges Pompidou, Paris, FranceEriK KLOK, MD, Principal investigator, Leiden University Medical Center Leiden, the NetherlandsOlivier HUGLI, Principal investigator, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02811237
- Sponsor's protocol ID
- PHRC 2015-04
- Acronym
- HOME-PE
- Status last verified
- Oct 2019
- First submitted
- 7 Jun 2016
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Piran S, Le Gal G, Wells PS, Gandara E, Righini M, Rodger MA, Carrier M. Outpatient treatment of symptomatic pulmonary embolism: a systematic review and meta-analysis. Thromb Res. 2013 Nov;132(5):515-9. doi: 10.1016/j.thromres.2013.08.012. Epub 2013 Aug 28.
PubMed 24035045Zondag W, Kooiman J, Klok FA, Dekkers OM, Huisman MV. Outpatient versus inpatient treatment in patients with pulmonary embolism: a meta-analysis. Eur Respir J. 2013 Jul;42(1):134-44. doi: 10.1183/09031936.00093712. Epub 2012 Oct 25.
PubMed 23100493Konstantinides SV, Torbicki A, Agnelli G, Danchin N, Fitzmaurice D, Galie N, Gibbs JS, Huisman MV, Humbert M, Kucher N, Lang I, Lankeit M, Lekakis J, Maack C, Mayer E, Meneveau N, Perrier A, Pruszczyk P, Rasmussen LH, Schindler TH, Svitil P, Vonk Noordegraaf A, Zamorano JL, Zompatori M; Task Force for the Diagnosis and Management of Acute Pulmonary Embolism of the European Society of Cardiology (ESC). 2014 ESC guidelines on the diagnosis and management of acute pulmonary embolism. Eur Heart J. 2014 Nov 14;35(43):3033-69, 3069a-3069k. doi: 10.1093/eurheartj/ehu283. Epub 2014 Aug 29. No abstract available.
PubMed 25173341Aujesky D, Roy PM, Verschuren F, Righini M, Osterwalder J, Egloff M, Renaud B, Verhamme P, Stone RA, Legall C, Sanchez O, Pugh NA, N'gako A, Cornuz J, Hugli O, Beer HJ, Perrier A, Fine MJ, Yealy DM. Outpatient versus inpatient treatment for patients with acute pulmonary embolism: an international, open-label, randomised, non-inferiority trial. Lancet. 2011 Jul 2;378(9785):41-8. doi: 10.1016/S0140-6736(11)60824-6. Epub 2011 Jun 22.
PubMed 21703676Zondag W, Mos IC, Creemers-Schild D, Hoogerbrugge AD, Dekkers OM, Dolsma J, Eijsvogel M, Faber LM, Hofstee HM, Hovens MM, Jonkers GJ, van Kralingen KW, Kruip MJ, Vlasveld T, de Vreede MJ, Huisman MV; Hestia Study Investigators. Outpatient treatment in patients with acute pulmonary embolism: the Hestia Study. J Thromb Haemost. 2011 Aug;9(8):1500-7. doi: 10.1111/j.1538-7836.2011.04388.x.
PubMed 21645235Roy PM, Penaloza A, Hugli O, Klok FA, Arnoux A, Elias A, Couturaud F, Joly LM, Lopez R, Faber LM, Daoud-Elias M, Planquette B, Bokobza J, Viglino D, Schmidt J, Juchet H, Mahe I, Mulder F, Bartiaux M, Cren R, Moumneh T, Quere I, Falvo N, Montaclair K, Douillet D, Steinier C, Hendriks SV, Benhamou Y, Szwebel TA, Pernod G, Dublanchet N, Lapebie FX, Javaud N, Ghuysen A, Sebbane M, Chatellier G, Meyer G, Jimenez D, Huisman MV, Sanchez O; HOME-PE Study Group. Triaging acute pulmonary embolism for home treatment by Hestia or simplified PESI criteria: the HOME-PE randomized trial. Eur Heart J. 2021 Aug 31;42(33):3146-3157. doi: 10.1093/eurheartj/ehab373.
PubMed 34363386
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Criteria for Hospitalization or Outpatient Management of Patients With Pulmonary Embolism, Hestia Rule Versus Simplified PESI Score : an Open-label Controlled Randomized International Trial (HOME-PE)
- ClinicalTrials.gov ID
- NCT02811237
- Acronym / sponsor ID
- HOME-PE / PHRC 2015-04
- Conditions
- Pulmonary Embolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,975 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Collaborators
- European Georges Pompidou Hospital, Hospital Universitario Ramon y Cajal, Leiden University Medical Center, Cliniques universitaires Saint-Luc- Université Catholique de Louvain, University of Lausanne Hospitals
- Study start
- Jan 2017 (actual)
- Primary completion
- Jul 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 23 Jun 2016 (estimated)
- 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.
Several studies have demonstrated the possibility of outpatient management or early discharge for certain patients presenting acute pulmonary embolism (PE), providing a suitable structure is in place.
The approach featured in the most recent guidelines on acute PE of the European Society of Cardiology, refers to an all-cause mortality risk assessment using the Pulmonary Embolism Severity Index (PESI) score or the simplified PESI score (sPESI). The sPESI takes into account demographics (age), patient history (cancer, cardiac or respiratory disease), and clinical data (systolic blood pressure, heart rate, oxygen saturation). Outpatient care is offered to low-risk patients, providing that all the conditions pertaining to start anticoagulant treatment and follow-up at home are met.
An alternative approach based on a list of simple criteria has been developed as the one used in HESTIA study. The main criteria included in the HESTIA rule consist of absence of the following: hemodynamic instability, need for oxygen therapy, high-risk of hemorrhage, renal or liver failure, or other medical or social conditions requiring hospitalization.
The investigators hereby propose comparing these two approaches in an open-label, controlled randomized international trial with blinded adjudication of endpoints.
The main objective is to demonstrate, in normotensive PE patients, that a strategy based on the HESTIA rule compared to a strategy based on the simplified PESI score is at least as safe as regards the 30-day-rate of adverse events (recurrent VTE, major bleeding or death).
The major secondary objectives are to demonstrate, in normotensive PE patients, that a strategy based on the HESTIA rule compared to a strategy based on the simplified PESI score is more effective :
- As regards the rate of patients eventually managed as outpatients.
- As regards the rate of patients, in theory, eligible for outpatient care,
Detailed description
All patients admitted in the Emergency Department of the participating centres and diagnosed with PE will be eligible and assessed for potential inclusion.
Included patients will be randomized into two groups (1:1) and stratified by centre. Data will be recorded in a computerized case report form (e-CRF) enabling the randomization.
The HESTIA group will receive outpatient care proposal based on HESTIA criteria. The sPESI group will receive outpatient care proposal based on the simplified PESI score. Any reason for management (hospitalization or outpatient treatment) not based on the recommendation will be explained and documented in the e-CRF.
Follow-up will occur within 72 hours after inclusion, at 14 days, 1 month, and 3 months in both groups to gather clinical event data (recurrent VTE, major bleeding, death), treatment data, unscheduled hospitalizations and patient satisfaction assessment results.
The major objectives will test HESTIA based strategy versus sPESI based strategy in a hierarchical approach:
- step 1: non-inferiority analysis on the rate of adverse events,
- if yes, step 2: superiority analysis on the rate of patients managed as outpatients,
- if yes, step3: superiority analysis on the rate of patients, in theory, eligible for outpatient care.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HESTIA group | Other | Other: HESTIA |
| sPESI group | Other | Other: sPESI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Admission to Emergency Department or unscheduled consultation in one of the participating centres;
- Symptomatic pulmonary embolism objectively confirmed according to the European Society of Cardiology criteria
- Insurance cover according to local legislation;
- Age ≥18 years;
- Free informed consent according to local legislation
Key exclusion criteria (3 listed)
- 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;
- Diagnosis of pulmonary embolism established more than 24H before inclusion;
- More than 48h between first presentation to the Emergency unit and inclusion - - Factors rendering 30-day follow-up impossible;
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 |
|---|---|---|
| HESTIAManagement based on the HESTIA rule: * If the rule is negative, meaning that patient meet none of the exclusion criteria of the rule, the proposed management will be outpatient care. * In the other cases, the patient will receive in-hospital care. Any reason for management (hospitalization or outpatient treatment) not based on the recommendation will be explained and documented in the e-CRF. | Other | HESTIA group |
| sPESIManagement based on the simplified PESI score: * If the sPESI score =0, the proposed management will be outpatient care. * In the other cases, the patient will receive in-hospital care. Any reason for management (hospitalization or outpatient treatment) not based on the recommendation will be explained and documented in the e-CRF. | Other | sPESI group |
Primary outcome
The rate of the composite of recurrent VTE, major bleeding and all cause death at 30 days
Time frame: 30 days
* Recurrent VTE: objectively confirmed pulmonary embolism or deep venous thrombosis objectively confirmed. * Major bleeding: according to the International Society on Thrombosis and Haemostasis' criteria. * Death: all-cause mortality.
13 secondary outcomes
The rate of patients actually managed as outpatients (meaning patients discharged home within 24 hours after the inclusion in the study (first major secondary objective))
Time frame: 1 day
The rate of "low-risk" patients in theory eligible for outpatient care (second major secondary objective)
Time frame: 1 day
Safety endpoints - Rate of cumulative events
Time frame: 14 days, 30 days, 90 days
Safety endpoints - Recurrent VTE
Time frame: 14 days, 30 days, 90 days
Safety endpoints - Suspected recurrent VTE
Time frame: 14 days, 30 days, 90 days
Safety endpoints - Major Bleeding
Time frame: 14 days, 30 days, 90 days
Safety endpoints - Non major bleeding
Time frame: 14 days, 30 days, 90 days
Safety endpoints - Death
Time frame: 14 days, 30 days, 90 days
Safety endpoints - Serious adverse event
Time frame: 14 days, 30 days, 90 days
Applicability of management strategies
Time frame: 1 day
Resources utilization
Time frame: Day 90
Patient satisfaction with care
Time frame: 30 days
Patient quality of life
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
- Background: PubMed 24035045Piran S, Le Gal G, Wells PS, Gandara E, Righini M, Rodger MA, Carrier M. Outpatient treatment of symptomatic pulmonary embolism: a systematic review and meta-analysis. Thromb Res. 2013 Nov;132(5):515-9. doi: 10.1016/j.thromres.2013.08.012. Epub 2013 Aug 28.
- Background: PubMed 23100493Zondag W, Kooiman J, Klok FA, Dekkers OM, Huisman MV. Outpatient versus inpatient treatment in patients with pulmonary embolism: a meta-analysis. Eur Respir J. 2013 Jul;42(1):134-44. doi: 10.1183/09031936.00093712. Epub 2012 Oct 25.
- Background: PubMed 25173341Konstantinides SV, Torbicki A, Agnelli G, Danchin N, Fitzmaurice D, Galie N, Gibbs JS, Huisman MV, Humbert M, Kucher N, Lang I, Lankeit M, Lekakis J, Maack C, Mayer E, Meneveau N, Perrier A, Pruszczyk P, Rasmussen LH, Schindler TH, Svitil P, Vonk Noordegraaf A, Zamorano JL, Zompatori M; Task Force for the Diagnosis and Management of Acute Pulmonary Embolism of the European Society of Cardiology (ESC). 2014 ESC guidelines on the diagnosis and management of acute pulmonary embolism. Eur Heart J. 2014 Nov 14;35(43):3033-69, 3069a-3069k. doi: 10.1093/eurheartj/ehu283. Epub 2014 Aug 29. No abstract available.
- Background: PubMed 21703676Aujesky D, Roy PM, Verschuren F, Righini M, Osterwalder J, Egloff M, Renaud B, Verhamme P, Stone RA, Legall C, Sanchez O, Pugh NA, N'gako A, Cornuz J, Hugli O, Beer HJ, Perrier A, Fine MJ, Yealy DM. Outpatient versus inpatient treatment for patients with acute pulmonary embolism: an international, open-label, randomised, non-inferiority trial. Lancet. 2011 Jul 2;378(9785):41-8. doi: 10.1016/S0140-6736(11)60824-6. Epub 2011 Jun 22.
- Background: PubMed 21645235Zondag W, Mos IC, Creemers-Schild D, Hoogerbrugge AD, Dekkers OM, Dolsma J, Eijsvogel M, Faber LM, Hofstee HM, Hovens MM, Jonkers GJ, van Kralingen KW, Kruip MJ, Vlasveld T, de Vreede MJ, Huisman MV; Hestia Study Investigators. Outpatient treatment in patients with acute pulmonary embolism: the Hestia Study. J Thromb Haemost. 2011 Aug;9(8):1500-7. doi: 10.1111/j.1538-7836.2011.04388.x.
- Derived from this study: PubMed 34363386Roy PM, Penaloza A, Hugli O, Klok FA, Arnoux A, Elias A, Couturaud F, Joly LM, Lopez R, Faber LM, Daoud-Elias M, Planquette B, Bokobza J, Viglino D, Schmidt J, Juchet H, Mahe I, Mulder F, Bartiaux M, Cren R, Moumneh T, Quere I, Falvo N, Montaclair K, Douillet D, Steinier C, Hendriks SV, Benhamou Y, Szwebel TA, Pernod G, Dublanchet N, Lapebie FX, Javaud N, Ghuysen A, Sebbane M, Chatellier G, Meyer G, Jimenez D, Huisman MV, Sanchez O; HOME-PE Study Group. Triaging acute pulmonary embolism for home treatment by Hestia or simplified PESI criteria: the HOME-PE randomized trial. Eur Heart J. 2021 Aug 31;42(33):3146-3157. doi: 10.1093/eurheartj/ehab373.
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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. This study is not recruiting at the moment.
Pierre-Marie ROY, MD.PhD principal investigator
CHU d'Angers, France
Olivier SANCHEZ, MD.PhD principal investigator
APHP Hôpital Européen Georges Pompidou, Paris, France
Menno HUISMAN, MD.PhD principal investigator
Leiden University Medical Center, Leiden, The Netherlands
28 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HESTIA and sPESI in people with Pulmonary Embolism, run by University Hospital, Angers at 28 sites in 5 countries.
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 1 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in France, Belgium, Netherlands, Switzerland, Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of the composite of recurrent VTE, major bleeding and all cause death at 30 days (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02811237, which also lists 6 linked publications.
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 1 Nov 2019.