Venous Thromboembolism Clinical Trial
— MOSEOfficial 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.
Status | Recruiting |
Enrollment | 15208 |
Est. completion date | October 2017 |
Est. primary completion date | April 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
Italy | University Magna Graecia of Catanzaro | Catanzaro | |
Italy | University Federico II of Naples | Naples |
Lead Sponsor | Collaborator |
---|---|
University Magna Graecia |
Italy,
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. — View Citation
de Franciscis S, Fregola S, Gallo A, Argirò G, Barbetta A, Buffone G, Caliò 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. — View Citation
Geerts WH, Bergqvist D, Pineo GF, Heit JA, Samama CM, Lassen MR, Colwell CW; American College of Chest Physicians.. 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. — View 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. Review. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | 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). | 6 months | No |
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