Clinical trial NCT02911012: Multiple Algorithms System Of All Scores in Embolism (MOSE)
Official title: Multiple Algorithms System Of All Scores in Embolism - MOSE
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Venous Thromboembolism
Risk Assessment
Risk Management
Lead sponsor: University Magna Graecia
Sponsor class: OTHER
First posted: 2016-09-22
Enrollment: 15208
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study is retrospective and provides analysis of an outpatient population of general practitioner for a total of 15208 patients

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* the patients had to present at the doctor's office for a consultation related to a health disorder;
* age ≥ 18 years;
* cooperative attitude;
* signature of the informed consent form granting permission to use their personal health data;

Exclusion Criteria:

- patients not signing the informed consent

Primary outcomes:
measure: VTE evaluation
timeFrame: 6 months
Secondary outcomes:
measure: BLD evaluation
timeFrame: 6 months
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: University Magna Graecia of Catanzaro
city: Naples
country: Italy
facility: University Federico II of Naples
Study officials:
affiliation: University Magna Graecia of Catanzaro
name: Stefano de Franciscis, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Magna Graecia of Catanzaro
name: Raffaele Serra, M.D., PhD.
role: STUDY_CHAIR
affiliation: Federico II University
name: Matteo Di Minno, M.D., PhD
role: STUDY_CHAIR
References:
citation: Geerts WH, Pineo GF, Heit JA, Bergqvist D, Lassen MR, Colwell CW, Ray JG. Prevention of venous thromboembolism: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest. 2004 Sep;126(3 Suppl):338S-400S. doi: 10.1378/chest.126.3_suppl.338S.
citation: Geerts WH, Bergqvist D, Pineo GF, Heit JA, Samama CM, Lassen MR, Colwell CW. Prevention of venous thromboembolism: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008 Jun;133(6 Suppl):381S-453S. doi: 10.1378/chest.08-0656.
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citation: de Franciscis S, Fregola S, Gallo A, Argiro G, Barbetta A, Buffone G, Calio FG, De Caridi G, Amato B, Serra R. PredyCLU: a prediction system for chronic leg ulcers based on fuzzy logic; part I - exploring the venous side. Int Wound J. 2016 Dec;13(6):1349-1353. doi: 10.1111/iwj.12529. Epub 2015 Nov 6.