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.

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Key information

Conditions

Validation of In-vitro Turbidometric Platelet Aggregation Assay

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Maximal platelet aggregation(MPA) for the TRAP and 5-HT baseline aggregation response and the 5-HT amplification of TRAP-induced aggregation

Time frame: Up to 6months

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.

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Important dates

Study start: 2013
Primary completion: 2013
First posted: Feb 26, 2014
Registry last updated: Feb 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.