In-Vivo Bleeding Volume Test for Platelet-Aspirin Interaction

NCT01047722 | Unknown Phase 1

• 1 other identifier: 3 BVT-ASA
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

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"

Outcome Measures

Primary Outcomes (1)

• Sensitivity, Specificity & ROC curve characteristics of the Bleeding Volume Test

  one year

Study Arms (2)

Patient drinks aspirin in Gatorade.

ACTIVE COMPARATOR

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

Gatorade Placebo

PLACEBO COMPARATOR

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

Procedure: Gatorade Placebo followed by Bleeding Volume Test.

Interventions

Aspirin ingestion followed by doing a Bleeding Volume Test DRUG

Patient drinks a glass of Gatorade containing 325 mg of aspirin, then one hour later a bleeding volume test is performed.

Patient drinks aspirin in Gatorade.

Gatorade Placebo followed by Bleeding Volume Test. PROCEDURE

Patient drinks a glass of Gatorade, then one hour later a bleeding volume test is performed.

Gatorade Placebo

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult male and female
• Ages 18 to 89 years old

You may not qualify if:

• Any history of HIV, Hepatitis C or presence of a blood-borne infectious disease

Sponsors & Collaborators

• Klein, Jeffrey A., M.D.: lead

Study Sites (2)

Private practice office

Newport Beach, California, 92660, United States

Location

Capistrano Surgery Center

San Juan Capistrano, California, 92675, United States

Location

Study Officials

• Jeffrey A Klein, MD

  University of Californiia, Riverside

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDIV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 12, 2010
• First Posted: January 13, 2010
• Study Start: January 1, 2010
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: July 21, 2015

Record last verified: 2015-07

Locations

US (2)