Multiple Algorithms System Of All Scores in Embolism - MOSE
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 15,208
- Locations
- 2
- Primary Endpoint
- VTE evaluation
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
VTE evaluation
Time Frame: 6 months
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)
Secondary Outcomes
- BLD evaluation(6 months)
Investigators
Prof. Stefano de Franciscis
Full Professor of Surgery
University Magna Graecia