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
  Purpose

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.


Condition Intervention Phase
Healthy
Procedure: Aspirin ingestion followed by doing a Bleeding Volume Test
Procedure: Gatorade Placebo followed by Bleeding Volume Test.
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Bleeding Volume Test: A Double-Blind Crossover Randomized Clinical Trial of an In-Vivo On-Line Test for Aspirin Effect and Resistance

Resource links provided by NLM:


Further study details as provided by Klein, Jeffrey A., M.D.:

Primary Outcome Measures:
  • Sensitivity, Specificity & ROC curve characteristics of the Bleeding Volume Test [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Aspirin dissolved in Gatorade
Patient receives 325 mg aspirin and then Bleeding Volume Test is done one hour later
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.
Placebo Comparator: Gatorade Placebo
Patient ingests Gatorade and 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01047722

Contacts
Contact: Jeffrey A Klein, MD 949-248-2632

Locations
United States, California
Private practice office Recruiting
Newport Beach, California, United States, 92660
Contact: Jeffrey A Klein, MD    949-248-1632      
Principal Investigator: Jeffrey A Klein, MD         
Capistrano Surgery Center Recruiting
San Juan Capistrano, California, United States, 92675
Contact: Jeffrey A Klein, MD    949-248-1632      
Principal Investigator: Jeffrey A Klein, MD         
Sponsors and Collaborators
Klein, Jeffrey A., M.D.
Investigators
Principal Investigator: Jeffrey A Klein, MD University of Californiia, Riverside
  More Information

No publications provided

Responsible Party: Jeffrey A. Klein, MD, Jeffrey A. Klein, MD, Inc
ClinicalTrials.gov Identifier: NCT01047722     History of Changes
Other Study ID Numbers: 3 BVT-ASA
Study First Received: January 12, 2010
Last Updated: June 14, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Klein, Jeffrey A., M.D.:
platelet function test
platelets
in-vivo test
aspirin
aspirin resistance
aspirin non-responsiveness
in-vivo
To assess the specificity and sensitivity of a novel in-vivo diagnostic test of platelet function
To use this test to define and assess "aspirin resistance"

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 21, 2014