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

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ClinicalTrials.gov Identifier: NCT00772434
Recruitment Status : Completed
First Posted : October 15, 2008
Last Update Posted : November 18, 2011
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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
Bleeding Disorder

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 : September 2008
Primary Completion Date : May 2011
Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


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. [ Time Frame: During study visit ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants will be recruited from a variety of community venues including the existing Rockefeller healthy volunteer database, the Tri-Institutional campus, area universities and medical centers, local colleges, and local business bulletin boards.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00772434


Locations
United States, New York
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
More Information

Responsible Party: Rockefeller University
ClinicalTrials.gov Identifier: NCT00772434     History of Changes
Other Study ID Numbers: AMA-0637
First Posted: October 15, 2008    Key Record Dates
Last Update Posted: November 18, 2011
Last Verified: November 2011

Additional relevant MeSH terms:
Hemorrhage
Blood Coagulation Disorders
Hemostatic Disorders
Pathologic Processes
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders