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Monitoring Trends in Venous Thromboembolism

Primary Purpose

Blood Coagulation Disorders, Venous Thromboembolism, Cardiovascular Diseases

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
University of Massachusetts, Worcester
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Blood Coagulation Disorders

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    June 30, 2003
    Last Updated
    September 9, 2013
    Sponsor
    University of Massachusetts, Worcester
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00063518
    Brief Title
    Monitoring Trends in Venous Thromboembolism
    Official Title
    Incidence Rates, Clinical Profile, and Outcomes of Patients With Venous Thromboembolism
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    September 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2003 (undefined)
    Primary Completion Date
    December 2007 (Actual)
    Study Completion Date
    December 2007 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Massachusetts, Worcester
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To describe time trends in the epidemiology of venous thromboembolism.
    Detailed Description
    BACKGROUND: Venous thromboembolism (VTE) has been estimated to be the third most common cardiovascular disorder. Frequently cited estimates of the incidence of VTE, and its associated outcomes, are based on studies conducted more than a decade ago and only in hospitalized patients. Contemporary data on the magnitude of this disorder, clinical profile of patients affected, acute and long-term outcomes, and use of different treatment strategies are needed given recent advances in diagnostic and therapeutic modalities. DESIGN NARRATIVE: The goals of the study are to collect population based data describing trends over time in the epidemiology of VTE including its incidence, management, short and long-term recurrence rates, and mortality. The study will take place in residents of the Worcester, Massachusetts, metropolitan area, (2000 census = 477,800) and will examine changes over time in these and additional endpoints for patients with validated VTE in 1998, 2000 and 2002 with a minimum follow-up of three years. Complementing the community based surveillance of VTE, newly diagnosed cases of VTE occurring in members of the largest Health Maintenance Organization (HMO) in Central Massachusetts between 1998 and 2002 will be identified. This cohort is tracked by an outpatient computer database allowing for the systematic collection of additional data on treatment practices and outcomes occurring outside of the hospital setting. The project will build on the investigators' clinical and epidemiological experience and on data collection methodologies used in the Worcester Deep Vein Thrombosis (DVT) study (1985-1989) and the ongoing Worcester Heart Attack Study. The medical records of Worcester area residents diagnosed with VTE and related diagnostic rubrics will be reviewed and validated according to pre-established diagnostic criteria. Records for additional hospitalizations and death certificates will be reviewed to examine trends in long-term recurrence and survival rates through 2005. The results of this study will provide much needed current reformation about the epidemiology of VTE and provide important data on current diagnostic and therapeutic strategies used in these patients. Implementation of this registry will set the stage for systematic long-term surveillance of this medically important problem.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Blood Coagulation Disorders, Venous Thromboembolism, Cardiovascular Diseases

    7. Study Design

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    No eligibility criteria
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Frederick Spencer
    Organizational Affiliation
    University of Massachusetts, Worcester
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Monitoring Trends in Venous Thromboembolism

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