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

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ClinicalTrials.gov Identifier: NCT01047722
Recruitment Status : Unknown
Verified July 2015 by Jeffrey Alan Klein, MD, Klein, Jeffrey A., M.D..
Recruitment status was:  Active, not recruiting
First Posted : January 13, 2010
Last Update Posted : July 21, 2015
Sponsor:
Information provided by (Responsible Party):
Jeffrey Alan Klein, MD, Klein, Jeffrey A., M.D.

Tracking Information
First Submitted Date  ICMJE January 12, 2010
First Posted Date  ICMJE January 13, 2010
Last Update Posted Date July 21, 2015
Study Start Date  ICMJE January 2010
Estimated Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2010)
Sensitivity, Specificity & ROC curve characteristics of the Bleeding Volume Test [ Time Frame: one year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01047722 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE In-Vivo Bleeding Volume Test for Platelet-Aspirin Interaction
Official Title  ICMJE Bleeding Volume Test: A Double-Blind Crossover Randomized Clinical Trial of an In-Vivo On-Line Test for Aspirin Effect and Resistance
Brief 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.

Detailed 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Active Comparator: Patient drinks aspirin in Gatorade.
    Patient drinks Gatorade containing 325 mg aspirin. Bleeding Volume Test is done one hour later.
    Intervention: Drug: 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 12, 2010)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2015
Estimated Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01047722
Other Study ID Numbers  ICMJE 3 BVT-ASA
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jeffrey Alan Klein, MD, Klein, Jeffrey A., M.D.
Study Sponsor  ICMJE Klein, Jeffrey A., M.D.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jeffrey A Klein, MD University of Californiia, Riverside
PRS Account Klein, Jeffrey A., M.D.
Verification Date July 2015

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