Hospitalization or Out-treatment ManagEment of Patients With Pulmonary Embolism: a Randomized Controlled Trial
- Conditions
- Pulmonary Embolism
- Interventions
- Other: HESTIAOther: sPESI
- Registration Number
- NCT02811237
- Lead Sponsor
- University Hospital, Angers
- Brief 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.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1975
- 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
- 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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HESTIA group HESTIA - sPESI group sPESI -
- Primary Outcome Measures
Name Time Method The rate of the composite of recurrent VTE, major bleeding and all cause death at 30 days 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.
- Secondary Outcome Measures
Name Time Method The rate of "low-risk" patients in theory eligible for outpatient care (second major secondary objective) 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 - Death 14 days, 30 days, 90 days The rate of all-cause death
Applicability of management strategies 1 day The rate of patients actually managed as outpatients among number of patientpatients eligible for outpatient management
Resources utilization 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.
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)) 1 day The rate of patients managed as outpatients defined by patients discharged home within 24 hours after the inclusion in the study.
Safety endpoints - Rate of cumulative events 14 days, 30 days, 90 days The rate of the composite of recurrent VTE, major bleeding and all-cause death,
Safety endpoints - Recurrent VTE 14 days, 30 days, 90 days The rate of recurrent VTE
Safety endpoints - Suspected recurrent VTE 14 days, 30 days, 90 days The rate of recurrent VTE suspicion
Safety endpoints - Major Bleeding 14 days, 30 days, 90 days The rate of major bleeding
Safety endpoints - Non major bleeding 14 days, 30 days, 90 days The rate of non-major clinically relevant bleeding
Safety endpoints - Serious adverse event 14 days, 30 days, 90 days The rate of serious adverse event as defined in good clinical practice
Patient satisfaction with care 30 days A specific questionnaire will be used at 30 days following inclusion:
- Anti-Clot Treatment - Specific Questionnaire (ACTS)Patient quality of life 30 days A specific questionnaire will be used at 30 days following inclusion:
- Patient-reported Pulmonary Embolism Quality of Life Questionnaire (PEmb-QoL).
Trial Locations
- Locations (28)
Hôpital de Namur
🇧🇪Namur, Belgium
Red Cross Hospital
🇳🇱Beverwijk, Netherlands
Leiden University Medical Center Leiden,
🇳🇱Leiden, Netherlands
Cliniques Universitaires Saint-Luc
🇧🇪Brussels, Belgium
Hôpital Erasme
🇧🇪Bruxelles, Belgium
Hôpital Saint-Pierre
🇧🇪Bruxelles, Belgium
CHU Brest
🇫🇷Brest, France
CHU de Liège
🇧🇪Liege, Belgium
Hôpital de Lausanne
🇨🇭Lausanne, Switzerland
Hia Brest
🇫🇷Brest, France
CHU Clermont-Ferrand
🇫🇷Clermont-Ferrand, France
Thibault Schotté
🇫🇷Le Mans, France
Hôpital de Genève
🇨🇭Geneve, Switzerland
CHU de Rouen
🇫🇷Rouen, France
CHU Saint Etienne
🇫🇷Saint Etienne, France
CH Toulon
🇫🇷Toulon, France
CHU Toulouse
🇫🇷Toulouse, France
TERGOOI
🇳🇱Hilversum, Netherlands
APHP Lariboisière
🇫🇷Paris, France
APHP Louis Mourier
🇫🇷Colombes, France
Angers University Hospital
🇫🇷Angers, France
CHU Dijon
🇫🇷Dijon, France
CHU de Montpellier
🇫🇷Montpellier, France
APHP Hôpital Européen Georges Pompidou
🇫🇷Paris, France
CHU Grenoble
🇫🇷Grenoble, France
APHP Cochin
🇫🇷Paris, France
Ramon y Cajal Hospital
🇪🇸Madrid, Spain
University Medical Center Utrecht
🇳🇱Utrecht, Netherlands