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

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.

Study Overview

• Status: Completed
• Conditions: Bleeding Disorder

• Study Type: Observational
• Enrollment (Actual): 412

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Rockefeller University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Rockefeller University
• Collaborators: Weill Medical College of Cornell University
• Investigators: Principal Investigator: Andreas Mauer, MD, Rockfeller University

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: October 14, 2008
• First Submitted That Met QC Criteria: October 14, 2008
• First Posted (Estimate): October 15, 2008

Study Record Updates

• Last Update Posted (Estimate): November 18, 2011
• Last Update Submitted That Met QC Criteria: November 17, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Blood Coagulation Disorders; Hemorrhage
• Other Study ID Numbers: AMA-0637