Multiple Algorithms System Of All Scores in Embolism (MOSE)

NCT02911012 | Unknown

• 1 other identifier: ER.ALL.2016.01
• Study Type: observational
• Target: 15,208
• Locations: 1 country
• Sites: 2

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.

Conditions

Venous Thromboembolism; Risk Assessment; Risk Management

Outcome Measures

Primary Outcomes (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)

  6 months

Secondary Outcomes (1)

• BLD evaluation

  6 months

Study Arms (1)

Study Group

The identified population will be assessed on VTE risk according to the risk score PADUA, CAPRINI, KHORANA, and IMPROVE for BLD risk.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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;

You may not qualify if:

• \- patients not signing the informed consent

Sponsors & Collaborators

• University Magna Graecia: lead

Study Sites (2)

University Magna Graecia of Catanzaro

Catanzaro, 88100, Italy

RECRUITING

University Federico II of Naples

Naples, 80100, Italy

RECRUITING

Related Publications (6)

• 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.

  PMID: 15383478 BACKGROUND

• 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.

  PMID: 18574271 BACKGROUND

• 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.

  PMID: 20738765 BACKGROUND

• 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.

  PMID: 26288124 BACKGROUND

• 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.

  PMID: 18216292 BACKGROUND

• 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.

  PMID: 26542425 BACKGROUND

MeSH Terms

Conditions

Venous Thromboembolism

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Stefano de Franciscis, M.D.

  University Magna Graecia of Catanzaro

  PRINCIPAL INVESTIGATOR

• Raffaele Serra, M.D., PhD.

  University Magna Graecia of Catanzaro

  STUDY CHAIR

• Matteo Di Minno, M.D., PhD

  Federico II University

  STUDY CHAIR

Central Study Contacts

Stefano de Franciscis, M.D.

CONTACT

+39337855466; defranci@unicz.it

Alessandro Gallo, Ph.D.

CONTACT

+393335823511; ales.gallo@unicz.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Surgery

Study Record Dates

• First Submitted: September 20, 2016
• First Posted: September 22, 2016
• Study Start: October 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: October 1, 2017
• Last Updated: November 28, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)