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In-Vivo Bleeding Volume Test for Platelet-Aspirin Interaction

NCT01047722 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2015-07-21

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

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.

Sponsors & Collaborators

  • Klein, Jeffrey A., M.D.

    lead INDIV

Principal Investigators

  • Jeffrey A Klein, MD · University of Californiia, Riverside

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01047722 on ClinicalTrials.gov