In-Vivo Bleeding Volume Test for Platelet-Aspirin Interaction (Aspirin-BVT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Klein, Jeffrey A., M.D..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Klein, Jeffrey A., M.D.
ClinicalTrials.gov Identifier:
NCT01047722
First received: January 12, 2010
Last updated: June 14, 2011
Last verified: June 2011

January 12, 2010
June 14, 2011
January 2010
December 2011   (final data collection date for primary outcome measure)
Sensitivity, Specificity & ROC curve characteristics of the Bleeding Volume Test [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01047722 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
In-Vivo Bleeding Volume Test for Platelet-Aspirin Interaction
Bleeding Volume Test: A Double-Blind Crossover Randomized Clinical Trial of an In-Vivo On-Line Test for Aspirin Effect and Resistance

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Diagnostic
Healthy
  • Procedure: 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.
  • Active Comparator: Aspirin dissolved in Gatorade
    Patient receives 325 mg aspirin and then Bleeding Volume Test is done one hour later
    Intervention: Procedure: Aspirin ingestion followed by doing a Bleeding Volume Test
  • Placebo Comparator: Gatorade Placebo
    Patient ingests Gatorade and one hour later a Bleeding Volume Test is performed
    Intervention: Procedure: Gatorade Placebo followed by Bleeding Volume Test.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 89 Years
Yes
Contact: Jeffrey A Klein, MD 949-248-2632
United States
 
NCT01047722
3 BVT-ASA
No
Jeffrey A. Klein, MD, Jeffrey A. Klein, MD, Inc
Klein, Jeffrey A., M.D.
Not Provided
Principal Investigator: Jeffrey A Klein, MD University of Californiia, Riverside
Klein, Jeffrey A., M.D.
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP