In-Vivo Bleeding Volume Test for Platelet-Aspirin Interaction (Aspirin-BVT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
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 or disease||Intervention/treatment||Phase|
|Healthy||Drug: Aspirin ingestion followed by doing a Bleeding Volume Test Procedure: Gatorade Placebo followed by Bleeding Volume Test.||Phase 1|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Bleeding Volume Test: A Double-Blind Crossover Randomized Clinical Trial of an In-Vivo On-Line Test for Aspirin Effect and Resistance|
|Study Start Date :||January 2010|
|Estimated Primary Completion Date :||October 2015|
|Estimated Study Completion Date :||October 2015|
Active Comparator: Patient drinks aspirin in Gatorade.
Patient drinks Gatorade containing 325 mg aspirin. Bleeding Volume Test is done one hour later.
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.
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.
- Sensitivity, Specificity & ROC curve characteristics of the Bleeding Volume Test [ Time Frame: one year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01047722
|United States, California|
|Private practice office|
|Newport Beach, California, United States, 92660|
|Capistrano Surgery Center|
|San Juan Capistrano, California, United States, 92675|
|Principal Investigator:||Jeffrey A Klein, MD||University of Californiia, Riverside|