Assessment of Bleeding Symptoms in Normal Individuals Using a Comprehensive History Phenotyping Instrument

Sponsor
Rockefeller University (Other)
Overall Status
Completed
CT.gov ID
NCT00772434
Collaborator
Weill Medical College of Cornell University (Other)
412
1
31.9
12.9

Study Details

Study Description

Brief Summary

A wide variety of individuals are at risk for bleeding, but even though bleeding symptoms are common it is difficult to compare different people's symptoms. Recent research has found that carefully designed surveys can be used to calculate a bleeding score that is useful for diagnosing bleeding disorders, but normal individuals have not been specifically studied in large numbers with a comprehensive survey. Whether factors like race, ethnicity, age, sex, aspirin use, and previous trauma and surgery influence bleeding scores is also unknown. The primary goal of this study is to use a comprehensive computerized questionnaire to record the bleeding symptoms of normal individuals and then assess the range and severity of bleeding symptoms in this normal population.

Secondary goals include determining whether race, ethnicity, age, sex, aspirin use, and previous trauma and surgery correlate with bleeding symptoms.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    412 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Assessment of Bleeding Symptoms in Normal Individuals Using a Comprehensive History Phenotyping Instrument
    Study Start Date :
    Sep 1, 2008
    Actual Primary Completion Date :
    May 1, 2011
    Actual Study Completion Date :
    May 1, 2011

    Outcome Measures

    Primary Outcome Measures

    1. Answers to bleeding history questions posed in the questionnaire and cofactors, such as participants' age, sex, history of prior hemostatic challenge, ASA use, ethnicity, and race. [During study visit]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • At least 18 years of age.

    • Self-assessed as being generally healthy.

    • Self-assessed as being able to accurately read and answer questions in English about their past medical histories.

    Exclusion Criteria:
    • A diagnosis of any disorder of hemostasis.

    • A diagnosis of any condition associated with an increased risk of bleeding, namely, any current or previous diagnosis of liver or kidney disease, and malignancy requiring treatment within the past year.

    • Use of heparin, low-molecular weight heparins, warfarin, clopidogrel, or other medications with known anticoagulant or anti-platelet properties in the past 30 days.

    • History, physical, or known laboratory findings suggestive of any other medical or psychological condition that would impair the participant's ability to accurately respond to questions about bleeding symptoms.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rockefeller University Hospital New York New York United States 10065

    Sponsors and Collaborators

    • Rockefeller University
    • Weill Medical College of Cornell University

    Investigators

    • Principal Investigator: Andreas Mauer, MD, Rockfeller University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rockefeller University
    ClinicalTrials.gov Identifier:
    NCT00772434
    Other Study ID Numbers:
    • AMA-0637
    First Posted:
    Oct 15, 2008
    Last Update Posted:
    Nov 18, 2011
    Last Verified:
    Nov 1, 2011

    Study Results

    No Results Posted as of Nov 18, 2011