Pulmonary Embolism Clinical Trial
— HOME-PEOfficial 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)
Verified date | October 2019 |
Source | University Hospital, Angers |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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,
Status | Completed |
Enrollment | 1975 |
Est. completion date | October 30, 2019 |
Est. primary completion date | July 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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; |
Country | Name | City | State |
---|---|---|---|
Belgium | Cliniques Universitaires Saint-Luc | Brussels | |
Belgium | Hôpital Erasme | Bruxelles | |
Belgium | Hôpital Saint-Pierre | Bruxelles | |
Belgium | CHU de Liège | Liege | |
Belgium | Hôpital de Namur | Namur | |
France | Angers University Hospital | Angers | |
France | CHU Brest | Brest | |
France | Hia Brest | Brest | |
France | CHU Clermont-Ferrand | Clermont-Ferrand | |
France | APHP Louis Mourier | Colombes | |
France | CHU Dijon | Dijon | |
France | CHU Grenoble | Grenoble | |
France | Thibault Schotté | Le Mans | |
France | CHU de Montpellier | Montpellier | |
France | APHP Cochin | Paris | |
France | APHP Hôpital Européen Georges Pompidou | Paris | |
France | APHP Lariboisière | Paris | |
France | CHU de Rouen | Rouen | |
France | CHU Saint Etienne | Saint Etienne | |
France | CH Toulon | Toulon | |
France | CHU Toulouse | Toulouse | |
Netherlands | Red Cross Hospital | Beverwijk | |
Netherlands | TERGOOI | Hilversum | |
Netherlands | Leiden University Medical Center Leiden, | Leiden | |
Netherlands | University Medical Center Utrecht | Utrecht | |
Spain | Ramon y Cajal Hospital | Madrid | |
Switzerland | Hôpital de Genève | Geneve | |
Switzerland | Hôpital de Lausanne | Lausanne |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Angers | Cliniques universitaires Saint-Luc- Université Catholique de Louvain, European Georges Pompidou Hospital, Hospital Universitario Ramon y Cajal, Leiden University Medical Center, University of Lausanne Hospitals |
Belgium, France, Netherlands, Spain, Switzerland,
Aujesky 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. — View Citation
Konstantinides SV, Torbicki A, Agnelli G, Danchin N, Fitzmaurice D, Galiè 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. Erratum in: Eur Heart J. 2015 Oct 14;36(39):2666. Eur Heart J. 2015 Oct 14;36(39):2642. — View Citation
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. Review. — View Citation
Zondag 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. — View Citation
Zondag 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
30 days | |
Secondary | 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. | 1 day | |
Secondary | 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. |
1 day | |
Secondary | Safety endpoints - Rate of cumulative events | The rate of the composite of recurrent VTE, major bleeding and all-cause death, | 14 days, 30 days, 90 days | |
Secondary | Safety endpoints - Recurrent VTE | The rate of recurrent VTE | 14 days, 30 days, 90 days | |
Secondary | Safety endpoints - Suspected recurrent VTE | The rate of recurrent VTE suspicion | 14 days, 30 days, 90 days | |
Secondary | Safety endpoints - Major Bleeding | The rate of major bleeding | 14 days, 30 days, 90 days | |
Secondary | Safety endpoints - Non major bleeding | The rate of non-major clinically relevant bleeding | 14 days, 30 days, 90 days | |
Secondary | Safety endpoints - Death | The rate of all-cause death | 14 days, 30 days, 90 days | |
Secondary | Safety endpoints - Serious adverse event | The rate of serious adverse event as defined in good clinical practice | 14 days, 30 days, 90 days | |
Secondary | Applicability of management strategies | The rate of patients actually managed as outpatients among number of patientpatients eligible for outpatient management | 1 day | |
Secondary | 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. | Day 90 | |
Secondary | Patient satisfaction with care | A specific questionnaire will be used at 30 days following inclusion: - Anti-Clot Treatment - Specific Questionnaire (ACTS) |
30 days | |
Secondary | 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). |
30 days |
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