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

Bleeding Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00772434
• Other study ID #: AMA-0637
• Status: Completed
• Phase: N/A
• First received: October 14, 2008
• Last updated: November 17, 2011
• Start date: September 2008
• Est. completion date: May 2011

Study information

• Verified date: November 2011
• Source: Rockefeller University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 412
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bleeding Disorder
• Blood Coagulation Disorders
• Hemorrhage
• Hemostatic Disorders

Locations

Country	Name	City	State
United States	Rockefeller University Hospital	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Rockefeller University	Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No