Impact Analysis of Prognostic Stratification for Pulmonary Embolism (iAPP)
Primary Purpose
Pulmonary Embolism
Status
Terminated
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
PESI score
Sponsored by
About this trial
This is an interventional other trial for Pulmonary Embolism
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Children
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
PESI score
Standard care
Arm Description
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)
standard care (i.e. no formally calculation of PESI on top)
Outcomes
Primary Outcome Measures
Length of hospital stay
Secondary Outcome Measures
Full Information
NCT ID
NCT03002467
First Posted
December 11, 2016
Last Updated
November 13, 2020
Sponsor
Università degli Studi dell'Insubria
1. Study Identification
Unique Protocol Identification Number
NCT03002467
Brief Title
Impact Analysis of Prognostic Stratification for Pulmonary Embolism
Acronym
iAPP
Official Title
Impact Analysis of Prognostic Stratification for Pulmonary Embolism: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Terminated
Why Stopped
Low recruitment rate
Study Start Date
September 2016 (undefined)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
December 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Università degli Studi dell'Insubria
4. Oversight
5. Study Description
Brief Summary
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:
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
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).
to demonstrate that the use of DOACs will reduce the duration of hospital stay of PE patients
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).
Detailed Description
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.
STUDY POPULATION
1.1 Population
Randomised physicians:
Each Local Investigator of participating canters. All participating centres are Internal Medicine Unit.
PE population:
Consecutive adult outpatients of any age, gender and race, with an objectively confirmed diagnosis of a suspected or unsuspected acute PE at the emergency department (ED) and admitted to participating units will be included.
Suspected PE means that diagnosis has been made by an imaging test (computed tomographic pulmonary angiography [CTPA], pulmonary angiography, V/Q lung scan) prescribed by a treating physician who had clinical suspicion of PE.
Unsuspected PE means that diagnosis has been made incidentally by an imaging test performed for other clinical indications (e.g. cancer staging or follow-up).
Objective diagnosis of acute PE means: a positive computed tomographic pulmonary angiography (CTPA), a positive pulmonary angiography, a high-probability V/Q lung scan (or perfusion lung scan with negative chest X-ray), or intermediate probability V/Q or perfusion lung scan with proximal deep-vein thrombosis (DVT) documented by compression ultrasonography.
1.2 Sample size calculation
The Investigators hypothesize that the distribution of hospital stay duration for PE will have a standard deviation of 4 days. The I vestigators also hypothesize that the mean duration of hospital stay will be reduced by at least 15% in PE patients whose treating physician will be randomised to formally use PESI and by 5% in PE patients whose treating physician will not be randomised to formally calculate PESI. Low-risk PE patients are almost 50% of all PE population. Therefore, with an α error of 0.05 and a statistical power (1-β error) of 80%, 200 patients for each group (a total of 400 patients) need to be enrolled to find a statistically significant difference (p<0.05) between the mean hospital stay length. As the variable 'hospital stay length' will have a non-normal distribution and needs to be expressed and reported as median, 10% extra patients need to be enrolled to reach a statistically significant difference with the previous statistical assumptions.
Final total sample size will be, therefore, of 440 patients (220 patients for each group)
OUTCOMES
Main study parameter/endpoint
The primary outcome is the median length of hospital stay
Secondary study parameters/endpoints
The secondary efficacy outcomes will be the following:
health-system measures
proportion of patients undergoing short-hospital stay
proportion of patients undergoing complete home-treatment
post-discharge hospital re-admission
post-discharge outpatient visits to emergency department
patient-related outcomes
quality of life (5-point Likert scale questionnaire)
The safety outcomes will be the following:
overall mortality
PE-related
PE-related mortality
recurrent PE and/or deep vein thrombosis (DVT)
major bleeding
clinically relevant non-major bleeding
minor bleeding
other anticoagulation-related complications (hematoma/infection at heparin or fondaparinux injection sites, heparin-induced thrombocytopenia)
Hospitalization-related
hospital-acquired infections (pneumonia; urinary tract infection; other)
iatrogenic complications
immobilization syndrome
pressure sores
Overall mortality, PE-related safety outcomes, post-discharge hospital re-admission and outpatient visits to emergency department will be measured at 14 days, 30 days, and 90 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
125 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PESI score
Arm Type
Experimental
Arm Description
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 Title
Standard care
Arm Type
No Intervention
Arm Description
standard care (i.e. no formally calculation of PESI on top)
Intervention Type
Other
Intervention Name(s)
PESI score
Primary Outcome Measure Information:
Title
Length of hospital stay
Time Frame
Up to 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Children
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alessandro Squizzato, MD PhD
Organizational Affiliation
Università degli Studi dell'Insubria
Official's Role
Principal Investigator
Facility Information:
City
Cuneo
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Impact Analysis of Prognostic Stratification for Pulmonary Embolism
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