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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,975
- 试验地点
- 33
- 主要终点
- The rate of the composite of recurrent VTE, major bleeding and all cause death at 30 days
研究概览
简要总结
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,
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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;
研究组 & 干预措施
HESTIA group
干预措施: HESTIA (Other)
sPESI group
干预措施: sPESI (Other)
结局指标
主要结局
The rate of the composite of recurrent VTE, major bleeding and all cause death at 30 days
时间窗: 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.
次要结局
- The rate of "low-risk" patients in theory eligible for outpatient care (second major secondary objective)(1 day)
- Safety endpoints - Death(14 days, 30 days, 90 days)
- Applicability of management strategies(1 day)
- Resources utilization(Day 90)
- 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)
- Safety endpoints - Rate of cumulative events(14 days, 30 days, 90 days)
- Safety endpoints - Recurrent VTE(14 days, 30 days, 90 days)
- Safety endpoints - Suspected recurrent VTE(14 days, 30 days, 90 days)
- Safety endpoints - Major Bleeding(14 days, 30 days, 90 days)
- Safety endpoints - Non major bleeding(14 days, 30 days, 90 days)
- Safety endpoints - Serious adverse event(14 days, 30 days, 90 days)
- Patient satisfaction with care(30 days)
- Patient quality of life(30 days)