Hospitalization or Out-treatment ManagEment of Patients With Pulmonary Embolism: a Randomized Controlled Trial (HOME-PE)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02811237 |
|
Recruitment Status :
Completed
First Posted : June 23, 2016
Last Update Posted : November 1, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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,
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pulmonary Embolism | Other: HESTIA Other: sPESI | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1975 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Other |
| 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) |
| Actual Study Start Date : | January 2017 |
| Actual Primary Completion Date : | July 2019 |
| Actual Study Completion Date : | October 30, 2019 |
| Arm | Intervention/treatment |
|---|---|
| HESTIA group |
Other: HESTIA
Management based on the HESTIA rule:
Any reason for management (hospitalization or outpatient treatment) not based on the recommendation will be explained and documented in the e-CRF. |
| sPESI group |
Other: sPESI
Management 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. |
- 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.
- 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 patients managed as outpatients defined by patients discharged home within 24 hours after the inclusion in the study.
- The rate of "low-risk" patients in theory eligible for outpatient care (second major secondary objective) [ Time Frame: 1 day ]
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.
- Safety endpoints - Rate of cumulative events [ Time Frame: 14 days, 30 days, 90 days ]The rate of the composite of recurrent VTE, major bleeding and all-cause death,
- Safety endpoints - Recurrent VTE [ Time Frame: 14 days, 30 days, 90 days ]The rate of recurrent VTE
- Safety endpoints - Suspected recurrent VTE [ Time Frame: 14 days, 30 days, 90 days ]The rate of recurrent VTE suspicion
- Safety endpoints - Major Bleeding [ Time Frame: 14 days, 30 days, 90 days ]The rate of major bleeding
- Safety endpoints - Non major bleeding [ Time Frame: 14 days, 30 days, 90 days ]The rate of non-major clinically relevant bleeding
- Safety endpoints - Death [ Time Frame: 14 days, 30 days, 90 days ]The rate of all-cause death
- Safety endpoints - Serious adverse event [ Time Frame: 14 days, 30 days, 90 days ]The rate of serious adverse event as defined in good clinical practice
- Applicability of management strategies [ Time Frame: 1 day ]The rate of patients actually managed as outpatients among number of patientpatients eligible for outpatient management
- Resources utilization [ Time Frame: Day 90 ]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.
- Patient satisfaction with care [ Time Frame: 30 days ]
A specific questionnaire will be used at 30 days following inclusion:
- Anti-Clot Treatment - Specific Questionnaire (ACTS)
- Patient quality of life [ Time Frame: 30 days ]
A specific questionnaire will be used at 30 days following inclusion:
- Patient-reported Pulmonary Embolism Quality of Life Questionnaire (PEmb-QoL).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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;
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02811237
Show 28 study locations
| Principal Investigator: | Pierre-Marie ROY, MD.PhD | CHU d'Angers, France | |
| Principal Investigator: | Olivier SANCHEZ, MD.PhD | APHP Hôpital Européen Georges Pompidou, Paris, France | |
| Principal Investigator: | Menno HUISMAN, MD.PhD | Leiden University Medical Center, Leiden, The Netherlands | |
| Principal Investigator: | David JIMENEZ, MD.PhD | Hospital Universitario Ramon y Cajal, Madrid, Spain | |
| Principal Investigator: | Andréa PENALOZA, MD.PhD | Clinique Unisersitaire Saint Luc, Brussels, Belgium | |
| Study Chair: | Guy MEYER, MD.PhD | APHP Hôpital Européen Georges Pompidou, Paris, France | |
| Principal Investigator: | EriK KLOK, MD | Leiden University Medical Center Leiden, the Netherlands | |
| Principal Investigator: | Olivier HUGLI | Centre Hospitalier Universitaire Vaudois |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University Hospital, Angers |
| ClinicalTrials.gov Identifier: | NCT02811237 |
| Other Study ID Numbers: |
PHRC 2015-04 |
| First Posted: | June 23, 2016 Key Record Dates |
| Last Update Posted: | November 1, 2019 |
| Last Verified: | October 2019 |
|
Pulmonary Embolism Embolism Embolism and Thrombosis Vascular Diseases |
Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases |