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.
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
- Conditions the study is for
- Venous Thromboembolism, Risk Assessment, Risk Management
- 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.
Italy2 sites, 2 recruiting
- 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
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).
- Conditions
- Venous Thromboembolism, Risk Assessment, Risk Management
- 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 group | Role | What they receive |
|---|---|---|
| Study Group | The 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.
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)
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.
- First posted22 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionApr 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University Magna Graecia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Stefano de Franciscis, University Magna Graecia
- Investigators
- Stefano de Franciscis, M.D., Principal investigator, University Magna Graecia of CatanzaroRaffaele Serra, M.D., PhD., Study chair, University Magna Graecia of CatanzaroMatteo Di Minno, M.D., PhD, Study chair, Federico II University
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 15383478Geerts 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 18574271Barbar 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 20738765Obi 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 26288124Khorana 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 18216292de 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple Algorithms System Of All Scores in Embolism - MOSE
- ClinicalTrials.gov ID
- NCT02911012
- Acronym / sponsor ID
- MOSE / ER.ALL.2016.01
- Conditions
- Venous Thromboembolism, Risk Assessment, Risk Management
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15,208 participants (estimated)
- Lead sponsor
- University Magna GraeciaUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 22 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | –The identified population will be assessed on VTE risk according to the risk score PADUA, CAPRINI, KHORANA, and IMPROVE for BLD risk. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (1 listed)
- patients not signing the informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
1 secondary outcome
BLD evaluation
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2016.
- Background: PubMed 15383478Geerts 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.
- Background: PubMed 18574271Geerts 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.
- Background: PubMed 20738765Barbar 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.
- Background: PubMed 26288124Obi 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.
- Background: PubMed 18216292Khorana 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.
- Background: PubMed 26542425de 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefano de Franciscis, M.D. principal investigator
University Magna Graecia of Catanzaro
Raffaele Serra, M.D., PhD. study chair
University Magna Graecia of Catanzaro
Matteo Di Minno, M.D., PhD study chair
Federico II University
2 sites in 1 country: see every site and its status.
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.