This study was purpose to evaluate a new method and instrument for detecting platelet aggregation function, establish the reference intervals for PL-11 platelet analyzer, and evaluate its clinical application. The evaluation was based on the guidelines of Clinical and Laboratory Standards Institute (CLSI or NCCLS) and Clinical Laboratory Improvement Amendment 88. Intravenous blood samples anticoagulated with sodium citrate were detected by PL-11 platelet analyzer. The reference intervals were defined after statistic analysis. The clinical diagnostic significance of the PL-11 platelet analyzer was evaluated by testing the change rate of platelet maximum aggregation rate (MAR) of acute cerebral infarction (ACI) patients in the department of Neurology who took clopidogrel 7 d before and after. The result showed that all the parameters meet the standard of CLIA'88. The platelet MAR of 247 healthy volunteers which was induced by PLR-06, PLR-07, PLR-09 and PLR-10, was detected by the PL-11 platelet analyzer, respectively. The MAR is 58.8 ± 10.1 (%), 61.2 ± 11.8 (%), 51 ± 10.2 (%), 53.1 ± 9.2 (%), respectively. The MAR of ACI patients is significantly lower than that after taking clopidogrel. It is concluded that the PL-11 platelet analyzer is an ideal platelet function detector for early warning and diagnosis of thromboembolic disease, which is worthy to be extended and applied.
Adolescent ; Adult ; Aged ; Aged, 80 and over ; Female ; Humans ; Male ; Middle Aged ; Platelet Aggregation ; Platelet Function Tests ; instrumentation ; methods ; Young Adult

In this article, the blood compatibility of polyurethanes (PUs) made by ourselves for catheters is studied by hemolysis test, platelets adhesion test, kinetic thrombus time test and dynamic clot formation. The results showed that these PUs all have excellent blood compatibility. Among these PUs, H50-100 and H60-100 have best blood compatibility. Additionally, the relationship between the structure and blood compatibility is discussed.
Animals ; Biocompatible Materials ; Blood ; Blood Coagulation Tests ; Catheterization ; instrumentation ; In Vitro Techniques ; Materials Testing ; Platelet Function Tests ; Polyurethanes ; Rabbits

BACKGROUND: Platelet Function Analyzer-100 (PFA-100, Dade-Behring, Germany) is an instrument that simulates in vivo hemostatic plug formation under high shear flow by measuring the time required to occlude aperture. We performed this study to reconfirm preanalytical variables and establish the reference intervals of Korean adults. METHODS: A total of 120 healthy individuals were enrolled. Closure times (CT) with the collagen/ epinephrine (CEPI) and the collagen/ADP (CADP) cartridges were measured. RESULTS: The reference intervals by the central 95th percentile were 82-182 sec for CEPI-CT and 62-109 sec for CADP-CT. Females had significantly longer CEPI- and CADP-CT than males (P=0.034 and 0.022, respectively). Individuals over 40 yr showed shorter CEPI- and CADP-CT compared with younger ones (P=0.002 and 0.003, respectively). CEPI- and CADP-CT values measured in the afternoon were significantly longer than corresponding ones in the morning (P<0.0001 in both conditions). Group O blood groups were related to longer CEPI- and CADP-CT compared with non-O blood groups (P=0.0003 and <0.0001, respectively). CADP-CT was weakly correlated with hematocrit (r=-0.296, P=0.001), but not CEPI-CT. CONCLUSIONS: We reconfirmed the preanalytical variables and established the reference intervals of PFA-100 CT in Korean adults. It is recommended that reference interval of this test should be verified according to age, diurnal variation, and ABO blood groups for optimal utilization.
ABO Blood-Group System ; Adult ; Female ; Humans ; Korea ; Male ; Middle Aged ; Platelet Function Tests/*instrumentation/standards ; Reference Values ; Regression Analysis ; Time Factors

BACKGROUND: An association has been reported between CYP2C19 polymorphism and the altered antiplatelet activity of clopidogrel. We investigated this association using the newly introduced platelet function analyzer (PFA)-200 (INNOVANCE PFA-200 System; Siemens Healthcare, Germany) P2Y test. METHODS: Polymorphisms of CYP2C19*2, *3, *17 and the degree of inhibition of platelet function were determined in 83 patients. Three different platelet function tests were used to evaluate the degree of platelet inhibition and to check the association with genotype. RESULTS: The post-procedure PFA-200 values of extensive metabolizers (EM) patients (285.3+/-38.8) were higher than those of intermediate metabolizers (IM) and poor metabolizers (PM) patients (227.7+/-98.3 and 133.7+/-99.2, respectively; P=0.024). Light transmittance aggregometry (LTA) and the VerifyNow system showed that the post-procedure values for EM patients were lower than those of IM and PM patients (LTA: 24.4+/-15.7, 34.1+/-17.6, and 42.2+/-16.9, respectively, P<0.001; VerifyNow: 133.2+/-60.5, 171.5+/-42.6, and 218.7+/-59.3, respectively, P<0.001). The high residual platelet reactivity (HPR) rates were significantly different among the EM, IM, and PM groups using PFA-200 (PM:IM:EM=82.4:40.6:11.8, P<0.001). CONCLUSIONS: Approximately, 59.0% of Korean patients with cardiovascular disease receiving clopidogrel had CYP2C19 loss-of-function genotypes classified as IM or PM, and the frequency was similar to the data from Asian people. The PFA-200, LTA, and VerifyNow platelet function tests revealed evidence of a significant association between the efficacy of clopidogrel and CYP2C19 genotypes.
Aged ; Cardiovascular Diseases/blood/*drug therapy ; Cytochrome P-450 CYP2C19/*genetics/metabolism ; Female ; Genotype ; Humans ; Male ; Middle Aged ; Phenotype ; Platelet Aggregation Inhibitors/*therapeutic use ; Platelet Function Tests/instrumentation ; Polymorphism, Genetic ; Ticlopidine/*analogs & derivatives/therapeutic use

BACKGROUND/AIMS: Impaired responsiveness to clopidogrel is common in patients with type 2 diabetes mellitus (DM). The aim of this study was to evaluate the clinical application of a point-of-care assay to detect impaired responsiveness to clopidogrel after coronary stent implantation in patients with type 2 DM. METHODS: We measured P2Y12 reaction units (PRU) with the VerifyNow point-of-care assay in 544 consecutive patients undergoing dual or triple (i.e., dual plus cilostazol) anti-platelet therapy after coronary stent implantation. High platelet reactivity (HPR) was defined as a PRU value > or = 240. RESULTS: The mean PRU values were 233.5 +/- 83.2 and 190.3 +/- 85.5 in patients undergoing dual or triple anti-platelet therapy, respectively (p < 0.001). Patients with DM manifested higher post treatment PRU values (238.3 +/- 82.4 vs. 210.8 +/- 86.8, p = 0.001) and a higher frequency of HPR (44.8% vs. 31.0%, p = 0.003) as compared to patients without DM. We also found that higher PRU values and a higher frequency of HPR were present in patients with DM who were undergoing both triple and dual anti-platelet therapy. However, the higher post-treatment PRU values observed in patients with DM decreased with triple anti-platelet therapy (219.4 +/- 82.5 vs. 247.9 +/- 81.1, p = 0.044). CONCLUSIONS: A point-of-care assay can detect elevated platelet reactivity and impaired responsiveness to clopidogrel in patients with type 2 DM. The addition of cilostazol to dual anti-platelet therapy may decrease post-treatment PRU values in patients with type 2 DM.
Aged ; Angioplasty, Balloon, Coronary/adverse effects/*instrumentation ; Aspirin/administration & dosage ; Chi-Square Distribution ; Coronary Disease/blood/*therapy ; Diabetes Mellitus, Type 2/*blood ; Drug Therapy, Combination ; Female ; Humans ; Logistic Models ; Male ; Middle Aged ; Platelet Activation/*drug effects ; Platelet Aggregation Inhibitors/*administration & dosage/adverse effects ; *Platelet Function Tests ; *Point-of-Care Systems ; Predictive Value of Tests ; Purinergic P2Y Receptor Antagonists/*administration & dosage/adverse effects ; Registries ; Republic of Korea ; Risk Assessment ; Risk Factors ; *Stents ; Tetrazoles/*administration & dosage/adverse effects ; Ticlopidine/administration & dosage/adverse effects/*analogs & derivatives ; Treatment Outcome

BACKGROUND/AIMS: Combination single-pill therapy can improve cost-effectiveness in a typical medical therapy. However, there is a little evidence about the efficacy and tolerability of combination single-pill antiplatelet therapy after percutaneous coronary intervention (PCI) with drug-eluting stents (DES). METHODS: From June to November 2012, in total, 142 patients who met the following criteria were enrolled: at least 18 years old; successful PCI with DES at least 3 months earlier; and regular medication of aspirin and clopidogrel with no side effects. After VerifyNow P2Y12 and aspirin assays, the combination single pill of aspirin and clopidogrel was given and laboratory tests were repeated 6 weeks later. RESULTS: At baseline, the incidence of aspirin resistance, defined as aspirin reaction unit (ARU) > or = 550, was 9.2%, that of clopidogrel resistance, defined as P2Y12 reaction unit (PRU) > or = 230, was 46.5%, and that of percent inhibition of PRU < 20% was 32.4%. At follow-up, the incidence of resistance by ARU value was 7.0%, 50.0% by PRU value, and 35.9% by percentage inhibition of PRU, respectively. The mean values of ARU (431.5 +/- 63.6 vs. 439.8 +/- 55.2; p = 0.216) and PRU (227.5 +/- 71.4 vs. 223.3 +/- 76.0; p = 0.350) were not significantly different before versus after antiplatelet-combination single-pill therapy. Five adverse events (3.5%) were observed during the study period. CONCLUSIONS: Combination single-pill antiplatelet therapy, which may reduce daily pill burden for patients after PCI with DES, demonstrated similar efficacy to separate dual-pill antiplatelet therapy.
Aged ; Antiplatyhelmintic Agents/*administration & dosage/adverse effects ; Aspirin/*administration & dosage/adverse effects ; Drug Combinations ; Drug Resistance ; *Drug-Eluting Stents ; Female ; Humans ; Intention to Treat Analysis ; Male ; Middle Aged ; Myocardial Ischemia/blood/diagnosis/*therapy ; Percutaneous Coronary Intervention/adverse effects/*instrumentation ; Platelet Function Tests ; Prospective Studies ; Tablets ; Ticlopidine/administration & dosage/adverse effects/*analogs & derivatives ; Time Factors ; Treatment Outcome