Study for Validation of In-vitro Turbidometric Platelet Aggregation Assay Using Human Blood in Healthy Volunteers
NCT ID: NCT02071628
Last Updated: 2014-02-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
10 participants
OBSERVATIONAL
2013-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* must be able to consent voluntarily
* consent to keep the study terms of obedience
Exclusion Criteria
* 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
20 Years
50 Years
ALL
Yes
Sponsors
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Asan Medical Center
OTHER
Responsible Party
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Kyun-Seop Bae
Asan Medical Center
Other Identifiers
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TGVT-1301
Identifier Type: -
Identifier Source: org_study_id
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