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CompletedNCT02071628Updated Feb 26, 2014

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

An observational study in Validation of In-vitro Turbidometric Platelet Aggregation Assay, sponsored by Asan Medical Center. Completed. Open to participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-02-26.

Sponsored by Asan Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10
Ages
20 Years to 50 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Validation of In-vitro Turbidometric Platelet Aggregation Assay
03

In context

Lead sponsor

Asan Medical Center is the lead sponsor of 578 studies on the registry; 74 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Healthy adult voulteers

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 6months

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 2013 and a primary completion of Dec 2013. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 13, 2014
First posted
Feb 26, 2014
Start
Dec 2013
Primary completionActual
Dec 2013
Last update
Feb 26, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 26, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02071628
Lead sponsor
Asan Medical Center
Responsible party
Kyun-Seop Bae (Asan Medical Center, Asan Medical Center) — Principal investigator
First posted
Feb 26, 2014
Start date
Dec 2013
Primary completion
Dec 2013
Last update
Feb 26, 2014
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.

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