Venous Thromboembolism Clinical Trial
Official title:
Multiple Algorithms System Of All Scores in Embolism - MOSE
The aim of this study is to overcome the current limits of the scoring systems used to
predict both the thrombotic (VTE) and hemorrhagic (BLD) risk for the patient. The main
problem of these scoring systems is due to the high rigidity related to the score assigned
at each risk item. The presence of an item assigns the full score for that item, without the
possibility to moderate that item's score. The final class of risk, for the patient, is the
sum of the scores of the selected items. The approach used for the assessment is based on
the presence or absence of certain items that will be summed.
Starting from scoring system currently used for VTE (PADUA, CAPRINI, KHORANA) and also for
BLD (IMPROVE), we will integrate all common items in a single scoring system managed by risk
management algorithms that can identify the different classes of risk.
The term venous thromboembolism is used to define any thrombotic event within the venous
system with or without pulmonary embolism (PE). Deep vein thrombosis (DVT) is still,
together with PE, possibly resulting therefrom, one of the most common and serious
complications that may occur in specific risk patients.
The current diagnostic systems allow to verify the presence, more quickly and frequently of
DVT; moreover, DVT and PE if not promptly diagnosed determine the underestimation of their
true incidence with negative consequences on morbidity and mortality.
The proposed systems also can be particularly incisive in monitoring the recurrence risk of
thromboembolic disease, that currently is entrusted exclusively to biological predictive
diagnostics (d-dimer, etc.) or diagnostic imaging (ultrasound, angio-ct etc.). These
monitoring methodologies were often burdened by an excess of false positives and, in any
case, present not always affordable cost for the health system.
The innovative system is proposed as monitoring and risk management tool through simple
repetition of the assessment.
VTE is the third leading cause of cardiovascular death after heart attack and stroke and in
Italy the estimate is 100 new cases per year per 100,000 inhabitants. The VTE risk criteria
are currently shared in the scientific community through the use of thrombotic risk tables
generally accepted and validated like PADUA, CAPRINI, KHORANA, etc.
The score calculated puts the patient in a band of risk (low / medium / high) indicated by a
number obtained by the sum of the detected risk factors. The identification of the risk
level VTE (low / medium / high) involves the administration of therapy (antiplatelet and /
or anticoagulant) according to the ACCP (American College of Chest Physicians' 2016).
Over the past years several scoring systems have been proposed. These systems are designed
to stratify the risk of thrombosis in patients characterized by significant differences. In
particular, some score systems consider risk factors not taken into account by others and
some are applied to patient populations that present a high risk of VTE already known.
The risk score assessment in a patient cannot be based only on measurements of the binary
questions (e.g. true or false) or using strict criteria in the analysis of physiological
variables; this involves the possibility of incurring errors of evaluation, especially in
those cases in which the patient manifests a borderline situation between a real risk and a
situation of relative normality.
MOSE proposes an innovative approach to identify a multi-risk, both VTE and BLD, that take
into account a series of variables, and situation, that the current score systems can't
describe.
The proposed study want to test a system that supports the physician like a DSS (Decision
Support System) in choosing the best therapy, to prevent VTE event, for the patient. Also,
the study want to evaluate the actual role of risk factors in determining the VTE.
The system is suitable for further developments in the study of bleeding risk in patients
with VTE risk and in the study of both risks (VTE vs BLD) as a function of time and
therapies.
The study is retrospective and provides analysis of an outpatient population of general
practitioner for a total of 15208 patients. To be eligible, the patients had to present at
the doctor's office for a consultation related to a health disorder and to meet the
following inclusion criteria: age ≥ 18 years, cooperative attitude, and signature of the
informed consent form granting permission to use their personal health data.
The identified population will be assessed on VTE risk according to the risk score PADUA,
CAPRINI, KHORANA, and IMPROVE for BLD risk.
The aim of this study is to implement a predictive system, based on fuzzy logic, capable to
identify patients with the risk to develop a VTE event.
In the first part of the study the presence or absence of VTE events will be hidden at the
researchers.
After calculating the MOSE risk score, results will be crossed with patients who actually
had a VTE event, and then the results will be compared with the scores systems used in the
study (PADUA, CAPRINI, KHORANA).
;
Observational Model: Cohort, Time Perspective: Retrospective
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