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Venous ThromboembolismMOSENCT02911012

Multiple Algorithms System Of All Scores in Embolism (MOSE)

An observational study of Venous Thromboembolism and Risk Assessment, run by University Magna Graecia at 2 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
How many people
15,208 participants
Where
2 sitesItaly
Study dates
Oct 2016to Oct 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: The study is retrospective and provides analysis of an outpatient population of general practitioner for a total of 15208 patients

Who may be able to join

  • 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;

Who cannot join

  • patients not signing the informed consent

Trial locations and contacts

2 sites in 1 country.

Stefano de Franciscis, M.D. contact

+39337855466

defranci@unicz.it

Alessandro Gallo, Ph.D. contact

+393335823511

ales.gallo@unicz.it

Italy2 sites, 2 recruiting
  • University Magna Graecia of Catanzaro

    Catanzaro, 88100

    Raffaele Serra, M.D., Ph.D., +3909613697380, rserra@unicz.it

    Recruiting
  • University Federico II of Naples

    Naples, 80100

    Matteo Di Minno, M.D., matteo.diminno@unina.it

    Recruiting

Other trials in Italy

About this study

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.

Read the 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).

Medical subject headings
Venous Thromboembolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02911012
Study groupRoleWhat they receive
Study GroupThe identified population will be assessed on VTE risk according to the risk score PADUA, CAPRINI, KHORANA, and IMPROVE for BLD risk.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. VTE evaluation

    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)

    Measured: 6 months

Secondary outcomes (1)
  1. BLD evaluation

    After calculating the MOSE risk score for BLD, results will be crossed with patients who actually had a bleeding risk, and then the results will be compared with the scores systems used in the study (IMPROVE).

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2016 (estimated)
  2. Study startOct 2016
  3. Primary completionApr 2017 (estimated)
  4. Study completionOct 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
15,208 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02911012
Sponsor's protocol ID
ER.ALL.2016.01
Acronym
MOSE
Status last verified
Nov 2016
First submitted
20 Sep 2016
Last updated
28 Nov 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 15383478
  • 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.

    PubMed 18574271
  • Barbar S, Noventa F, Rossetto V, Ferrari A, Brandolin B, Perlati M, De Bon E, Tormene D, Pagnan A, Prandoni P. A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism: the Padua Prediction Score. J Thromb Haemost. 2010 Nov;8(11):2450-7. doi: 10.1111/j.1538-7836.2010.04044.x.

    PubMed 20738765
  • Obi AT, Pannucci CJ, Nackashi A, Abdullah N, Alvarez R, Bahl V, Wakefield TW, Henke PK. Validation of the Caprini Venous Thromboembolism Risk Assessment Model in Critically Ill Surgical Patients. JAMA Surg. 2015 Oct;150(10):941-8. doi: 10.1001/jamasurg.2015.1841.

    PubMed 26288124
  • Khorana AA, Kuderer NM, Culakova E, Lyman GH, Francis CW. Development and validation of a predictive model for chemotherapy-associated thrombosis. Blood. 2008 May 15;111(10):4902-7. doi: 10.1182/blood-2007-10-116327. Epub 2008 Jan 23.

    PubMed 18216292
  • 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.

    PubMed 26542425

Questions about this trial

What is this clinical trial studying?

An observational study of Venous Thromboembolism and Risk Assessment, run by University Magna Graecia at 2 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Stefano de Franciscis, M.D. (+39337855466, defranci@unicz.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

VTE evaluation (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02911012, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2016.

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