Clinical trial NCT00772434: Assessment of Bleeding Symptoms in Normal Individuals Using a Comprehensive History Phenotyping Instrument
Official title: Assessment of Bleeding Symptoms in Normal Individuals Using a Comprehensive History Phenotyping Instrument
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bleeding Disorder
Lead sponsor: Rockefeller University
Sponsor class: OTHER
Collaborators: name: Weill Medical College of Cornell University
First posted: 2008-10-15
Enrollment: 412
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: During study visit
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Rockefeller University Hospital
state: New York
Study officials:
affiliation: Rockfeller University
name: Andreas Mauer, MD
role: PRINCIPAL_INVESTIGATOR
References: