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

Klein, Jeffrey A., M.D.

Status and phase: Unknown; Phase 1

Conditions: Healthy

Treatments: Drug: Aspirin ingestion followed by doing a Bleeding Volume Test; Procedure: Gatorade Placebo followed by Bleeding Volume Test.

Study type: Interventional

Identifiers

NCT01047722

3 BVT-ASA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

Patient drinks aspirin in Gatorade.

Active Comparator group

Description:

Patient drinks Gatorade containing 325 mg aspirin. Bleeding Volume Test is done one hour later.

Treatment:

Drug: Aspirin ingestion followed by doing a Bleeding Volume Test

Gatorade Placebo

Placebo Comparator group

Description:

Patient ingests Gatorade and one hour later a Bleeding Volume Test is performed

Treatment:

Procedure: Gatorade Placebo followed by Bleeding Volume Test.