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临床试验/NCT03002467
NCT03002467终止不适用

Impact Analysis of Prognostic Stratification for Pulmonary Embolism: A Randomized Controlled Trial

Università degli Studi dell'Insubria1 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2016年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
125
试验地点
1
主要终点
Length of hospital stay

研究概览

简要总结

The Investigator postulate that the use of PESI in addition to routine clinical practice, as opposed to routine clinical practice based on clinical judgment alone, will help physicians to correctly identify PE patients at low-risk of adverse outcomes. Considered that low-risk patients could benefit from a short hospital stay, aim of this study is to demonstrate that the use of PESI will lead physicians to discharge these patients earlier, thus reducing the duration of hospital stay of PE patients (primary outcome).

Outpatients diagnosed with PE at the emergency department (ED) and admitted to participating units represent the target population

As the availability of DOACs may influence the duration of hospital stay, the secondary objectives of the present study are:

  1. to demonstrate that a shorter hospital stay for low-risk PE patients (independently on the method used to identify them) will reduce the incidence of hospital-associated complications and improve patients satisfaction and quality of life, without increasing the incidence of PE-related complications
  2. to demonstrate that the use of PESI, as opposed to clinical judgment alone, will be associated with a greater proportion of patients discharged early (< 72 hours from ED admission) or treated entirely at home (< 24 hours from ED admission).
  3. to demonstrate that the use of DOACs will reduce the duration of hospital stay of PE patients
  4. to demonstrate that the use of DOACs, as opposed to standard treatment, will be associated with a greater proportion of patients discharged early (< 72 hours from ED admission) or treated entirely at home (< 24 hours from ED admission).

详细描述

STUDY DESIGN

Within 24 hours from acute PE diagnosis, each treating physician (local Investigator) will be centrally randomized. Treating physicians (local Investigator) of the participating Units will call the coordinating centres by phone for randomization. Before randomization, in order to avoid any influence on treatment choice, each treating physician (local Investigator) should declare in advance which treatment strategy will use for his patient (intention-to-treat), i.e. standard treatment with heparin plus vitamin K antagonist (standard group) or DOACs (DOACs group) Randomization will be stratified by treatment choice of the local Investigator. Each of two 'intention-to-treat' approaches will be therefore randomized to two arms, i.e. arm 1 or arm 2.

Arm 1: treating physicians must formally calculate PESI and report in the clinical record form* each day of hospitalization on top of routine clinical practice (standard care)

Arm 2: standard care (i.e. no formally calculation of PESI on top)

Randomization will be performed centrally with a 1:1 ratio, following a computer-generated list of randomization.

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

入选标准

  • Outpatients with objectively diagnosed PE, both suspected or unsuspected (e.g. during CT for cancer staging and/or follow-up)
  • Age > 18 years
  • Signature of written informed consent

排除标准

  • 未提供

结局指标

主要结局

Length of hospital stay

时间窗: Up to 3 months

次要结局

未报告次要终点

研究者

发起方
Università degli Studi dell'Insubria
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alessandro Squizzato

Associate Professor

Università degli Studi dell'Insubria

研究点 (1)

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