In-Vivo Bleeding Volume Test for Platelet-Aspirin Interaction

Healthy Clinical Trial

— Aspirin-BVT  

Official title:

Bleeding Volume Test: A Double-Blind Crossover Randomized Clinical Trial of an In-Vivo On-Line Test for Aspirin Effect and Resistance

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01047722
• Other study ID #: 3 BVT-ASA
• Status: Active, not recruiting
• Phase: Phase 1
• First received: January 12, 2010
• Last updated: July 18, 2015
• Start date: January 2010
• Est. completion date: October 2015

Study information

• Verified date: July 2015
• Source: Klein, Jeffrey A., M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Purpose of the present research project is to study a new in-vivo test for abnormal platelet function and to study the effect of certain drugs on clinical bleeding. This is a randomized clinical trial of a new in-vivo test of platelet function known as the bleeding volume test(BVT)which relies on an on-line measurement system. This trial will assess the sensitivity and specificity of the new BVT by studying the effects of aspirin which is known to affect platelet function in-vivo. This is not a clinical trial of drugs. This is a clinical trial of a novel in-vivo on-line laboratory test.

The BVT measures the total volume of blood in the discrete blotches of blood on the blotter paper during the BT test and thus the BVT gleans valuable additional information from the bleeding time test (BTT)procedure. We hypothesize that the BV test will be a more accurate, specific and sensitive test for diagnosing platelet function abnormalities and for detecting a person's bleeding tendency compared to the BTT, and commercially available in-vitro platelet function tests.

Description:

Purpose of the present research project is to study a new in-vivo test for abnormal platelet function and to study the effect of certain drugs on clinical bleeding. This is a randomized clinical trial of a new in-vivo test of platelet function known as the bleeding volume (BV) test which relies on an on-line measurement system. This trial will assess the sensitivity and specificity of the new BV test by studying the effects of aspirin which is known to affect platelet function in-vivo. This is not a clinical trial of drugs. This is a clinical trial of a novel laboratory test. The BV test results will be compared to the results of two commercially available platelet function tests (the VerifyNow test and the PFA-100 test) which requires 10 ml of blood taken from a peripheral vein.

The bleeding volume test is an extension of the classic Ivy Bleeding Time Test (BTT). The BTT, an in-vivo test for an abnormal bleeding tendency, involves making a small standardized cut in the skin and measuring the duration of bleeding. We hypothesize that measuring both the volume of blood lost (BV) and the BT will to provide a more useful test. The BV test is expected to provide an improved in-vivo technique for 1) investigating the effects of drugs on platelet function and 2) diagnosing diseases of abnormal platelet function such as von Willebrand disease (vWD), 3) identifying patients who are aspirin-resistant in the sense that they do not benefit from the beneficial effects of aspirin in preventing thromboembolic disease (heart attack and stroke), 4) providing insight into the effects of antithrombotic drugs such as clopidogrel, lidocaine and statins (HMG-CoA reductase inhibitors). The BV test will provide an inexpensive diagnostic test and improve patient care.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

• Adult male and female

• Ages 18 to 89 years old

Exclusion Criteria:

• Any history of HIV, Hepatitis C or presence of a blood-borne infectious disease

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Aspirin ingestion followed by doing a Bleeding Volume Test
Patient drinks a glass of Gatorade containing 325 mg of aspirin, then one hour later a bleeding volume test is performed.

Procedure:
• Gatorade Placebo followed by Bleeding Volume Test.
Patient drinks a glass of Gatorade, then one hour later a bleeding volume test is performed.

Locations

Country	Name	City	State
United States	Private practice office	Newport Beach	California
United States	Capistrano Surgery Center	San Juan Capistrano	California

Sponsors (1)

Lead Sponsor	Collaborator
Klein, Jeffrey A., M.D.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity, Specificity & ROC curve characteristics of the Bleeding Volume Test		one year	No