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Patient drinks aspirin in Gatorade. for Healthy Subjects (Aspirin-BVT Trial)

Phase 1
Waitlist Available
Led By Jeffrey A Klein, MD
Research Sponsored by Klein, Jeffrey A., M.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult male and female
Ages 18 to 89 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights

Aspirin-BVT Trial 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.

Eligible Conditions
  • Healthy Subjects

Aspirin-BVT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Aspirin-BVT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Sensitivity, Specificity & ROC curve characteristics of the Bleeding Volume Test

Aspirin-BVT Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Patient drinks aspirin in Gatorade.Active Control1 Intervention
Patient drinks Gatorade containing 325 mg aspirin. Bleeding Volume Test is done one hour later.
Group II: Gatorade PlaceboPlacebo Group1 Intervention
Patient ingests Gatorade and one hour later a Bleeding Volume Test is performed

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Klein, Jeffrey A., M.D.Lead Sponsor
4 Previous Clinical Trials
547 Total Patients Enrolled
Jeffrey A Klein, MDPrincipal InvestigatorUniversity of Californiia, Riverside
1 Previous Clinical Trials
14 Total Patients Enrolled

Frequently Asked Questions

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~7 spots leftby Mar 2025