Study for Validation of In-vitro Turbidometric Platelet Aggregation Assay Using Human Blood in Healthy Volunteers

This study is designed for validation of in-vitro platelet aggregation assay using human blood in healthy volunteers. 32ml blood, 2ml for complete blood count test and 30ml for platelet aggregation assay, was collected from ten subjects, respectively.

Preparation of Platelet Rich Plasma (PRP):

1. Collect human blood using 21g butterfly syringe and dilute 9:1 into 3.8% sodium citrate vacutainer vials.
2. Prepare platelet rich plasma (PRP) by centrifuging blood at 100 x g for 15 minutes at room temperature. Using a plastic transfer pipette, carefully transfer and combine PRP from multiple vacutainer tubes (if required) into a 15 mL conical tube.
3. PRP is removed re-centrifuge remaining blood in vacutainer tubes at 2000 x g for 15 minutes at room temp. to obtain platelet poor plasma (PPP). Transfer PPP to 15 mL conical tube.
4. Measure platelet count in combined PRP using Z1 Coulter Particle Counter or similar product. Adjust platelet count to a final concentration of 300,000 +- 10,000 platelets in PRP using PPP.

Aggregation Measurement:

Aggregation is measured using a model 490-X Chrono-Log Aggregometer or similar product. PPP is used as a reference to establish 100% optical transmission.

Study Overview

• Status: Completed
• Conditions: Validation of In-vitro Turbidometric Platelet Aggregation Assay

• Study Type: Observational
• Enrollment (Actual): 10

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy adult voulteers

Description

Inclusion Criteria:

• 20-50years old
• must be able to consent voluntarily
• consent to keep the study terms of obedience

Exclusion Criteria:

• blood coagulation disorder or bleeding disorder
• blood donation within 60 days or blood transfusion within 30 days before screening
• smoker or who stopped smoking within 1month before screening
• administration of drugs such as anticoagulants or antiplatelets or alcohol within 14 days before screening
• eligibility failure under investigator's judgements

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximal platelet aggregation(MPA) for the TRAP and 5-HT baseline aggregation response and the 5-HT amplification of TRAP-induced aggregation	Calculate each maximal platelet aggregation(MPA) for the TRAP and 5-HT baseline aggregation response and the 5-HT amplification of TRAP-induced aggregation, respectively. Compare the results with previous datas to evaluate the analysis machine and the assay methods.	Up to 6months

Collaborators and Investigators

• Sponsor: Asan Medical Center

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: January 13, 2014
• First Submitted That Met QC Criteria: February 22, 2014
• First Posted (Estimate): February 26, 2014

Study Record Updates

• Last Update Posted (Estimate): February 26, 2014
• Last Update Submitted That Met QC Criteria: February 22, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: TGVT-1301