An interventional study of HESTIA and sPESI in Pulmonary Embolism, sponsored by University Hospital, Angers. Completed at 28 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-01.
Sponsored by University Hospital, Angers · Not applicable, Interventional, and Other
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 :
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:
739 studies on the registry are indexed under Pulmonary Embolism; 159 are open to participants now.
This study's enrollment of 1,975 is above the median of 150 across 381 interventional studies indexed under Pulmonary Embolism.
Browse Pulmonary Embolism studies →University Hospital, Angers is the lead sponsor of 464 studies on the registry; 116 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other: HESTIA
Other: sPESI
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.
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.
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.
Time frame: 30 days
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.
Time frame: 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.
Time frame: 1 day
Safety endpoints - Rate of cumulative events
The rate of the composite of recurrent VTE, major bleeding and all-cause death,
Time frame: 14 days, 30 days, 90 days
Safety endpoints - Recurrent VTE
The rate of recurrent VTE
Time frame: 14 days, 30 days, 90 days
Safety endpoints - Suspected recurrent VTE
The rate of recurrent VTE suspicion
Time frame: 14 days, 30 days, 90 days
Safety endpoints - Major Bleeding
The rate of major bleeding
Time frame: 14 days, 30 days, 90 days
Safety endpoints - Non major bleeding
The rate of non-major clinically relevant bleeding
Time frame: 14 days, 30 days, 90 days
Safety endpoints - Death
The rate of all-cause death
Time frame: 14 days, 30 days, 90 days
Safety endpoints - Serious adverse event
The rate of serious adverse event as defined in good clinical practice
Time frame: 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
Time frame: 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.
Time frame: Day 90
Patient satisfaction with care
A specific questionnaire will be used at 30 days following inclusion: - Anti-Clot Treatment - Specific Questionnaire (ACTS)
Time frame: 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).
Time frame: 30 days
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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University Hospital, Angers