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Thrombolysis in stroke patients: Comparability of point-of-care versus central laboratory international normalized ratio.

ABSTRACT: In acute stroke patients, thrombolysis is one gold standard therapy option within the first four hours after the ischemic event. A contraindication for thrombolysis is an International Normalized Ratio (INR) value >1.7. Since time is brain, rapid and reliable INR results are fundamental. Aim was to compare INR values determined by central laboratory (CL) analyzer and Point-of-Care Testing(POCT)-device and to evaluate the quality of POCT performance in cases of potential therapeutic thrombolysis at a certified stroke unit.In 153 patients INR measurements using POCT-devices (HEMOCHRON Signature Elite®) were compared to INR measurements (BCS®XP) performed at the central laboratory. Outlier evaluation was performed regarding the critical thrombolysis cut-off.Overall, we demonstrated a significant correlation (r = 0.809, p<0.0001) between both measurement methods. Mean value of the absolute difference between CL-INR and POCT-INR measurements was 0.23. In 95.4% of these cases, no differences regarding the critical cut-off (INR 1.7) were observed. POCT-INR values tended to be higher than the CL-INR values (p = 0.01). In 4.6% cases, a different value regarding thrombolysis cut-off was found. All patients were >75 years.POCT-INR measurements based on our POCT concept are suitable to determine INR values in critical stroke patients. Nevertheless, outlier evaluation is mandatory.

SUBMITTER: Dolscheid-Pommerich RC

PROVIDER: S-EPMC5761884 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Thrombolysis in stroke patients: Comparability of point-of-care versus central laboratory international normalized ratio.

Dolscheid-Pommerich Ramona C RC Dolscheid Sarah S Eichhorn Lars L Stoffel-Wagner Birgit B Graeff Ingo I

PloS one 20180110 1

<h4>Background</h4>In acute stroke patients, thrombolysis is one gold standard therapy option within the first four hours after the ischemic event. A contraindication for thrombolysis is an International Normalized Ratio (INR) value >1.7. Since time is brain, rapid and reliable INR results are fundamental. Aim was to compare INR values determined by central laboratory (CL) analyzer and Point-of-Care Testing(POCT)-device and to evaluate the quality of POCT performance in cases of potential therap ...[more]

PMID: 29320558

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Project description:Fulfilling the requirements of point-of-care testing (POCT) training regarding proper execution of measurements and compliance with internal and external quality control specifications is a great challenge. Our aim was to compare the values of the highly critical parameter hemoglobin (Hb) determined with POCT devices and central laboratory analyzer in the highly vulnerable setting of an emergency department in a supra maximal care hospital to assess the quality of POCT performance. In 2548 patients, Hb measurements using POCT devices (POCT-Hb) were compared with Hb measurements performed at the central laboratory (Hb-ZL). Additionally, sub collectives (WHO anemia classification, patients with Hb <8 g/dl and suprageriatric patients (age >85y.) were analyzed. Overall, the correlation between POCT-Hb and Hb-ZL was highly significant (r = 0.96, p<0.001). Mean difference was -0.44g/dl. POCT-Hb values tended to be higher than Hb-ZL values (t(2547) = 36.1, p<0.001). Standard deviation of the differences was 0.62 g/dl. Only in 26 patients (1%), absolute differences >2.5g/dl occurred. McNemar´s test revealed significant differences regarding anemia diagnosis according to WHO definition for male, female and total patients (? p<0.001; ? p<0.001, total p<0.001). Hb-ZL resulted significantly more often in anemia diagnosis. In samples with Hb<8g/dl, McNemar´s test yielded no significant difference (p = 0.169). In suprageriatric patients, McNemar´s test revealed significant differences regarding anemia diagnosis according to WHO definition in male, female and total patients (? p<0.01; ? p = 0.002, total p<0.001). The difference between Hb-ZL and POCT-Hb with Hb<8g/dl was not statistically significant (<8g/dl, p = 1.000). Overall, we found a highly significant correlation between the analyzed hemoglobin concentration measurement methods, i.e. POCT devices and at the central laboratory. The results confirm the successful implementation of the presented POCT concept. Nevertheless some limitations could be identified in anemic patients stressing the importance of carefully examining clinically implausible results.

Project description:BackgroundLife-long vitamin K antagonist (VKA) therapy is recommended as a standard of care in antiphospholipid syndrome (APS) patients with thrombosis. Concerns have been raised about the validity of international normalized ratio (INR) measurements in lupus anticoagulant (LA)-positive APS patients because LA may interfere with phospholipid-dependent coagulation tests and could elevate INR measurements.ObjectivesHere, we aimed to determine the interference of antigen-specific monoclonal and isolated patient antibodies with LA activity on INR measurements.MethodsPooled normal plasma and control plasma from patients on VKA (without LA) were incubated with monoclonal and isolated patient immunoglobulin G antiprothrombin and anti-beta-2-glycoprotein I antibodies that express LA activity. INR was determined before and after addition using 3 laboratory assays (Owren STA-Hepato Prest, Quick STA-NeoPTimal, and Quick STA-Neoplastine R) and 1 point-of-care test device (CoaguChek Pro II).ResultsAntiprothrombin and anti-beta-2-glycoprotein I antibodies with LA activity interfered with recombinant human thromboplastin reagents (Quick STA-Neoplastine R and CoaguChek Pro II), particularly when added to plasma of VKA-treated controls. This effect was most evident on point-of-care test INR measurements, while the recombinant Quick reagent exhibited a lesser degree of interference. In contrast, tissue-derived thromboplastin reagents (Owren STA-Hepato Prest and Quick STA-NeoPTimal) remained largely unaffected by these antibodies, both in pooled normal plasma and VKA anticoagulated control plasma. Among these reagents, the Owren INR reagent exhibited the lowest sensitivity to the influence of LA antibodies. This observed difference in sensitivity is independent of the plasma dilution factor or the presence of factor V or fibrinogen in Owren reagent.ConclusionINR reagents that utilize recombinant human thromboplastin are more sensitive to the presence of monoclonal and patient-derived antibodies with LA activity. Consequently, APS patients positive for LA should be monitored using tissue-derived thromboplastin reagents, given its reduced susceptibility to interference by LA-causing antibodies.

Project description:BackgroundCurrently, there is a lack of sepsis screening tools that can be widely used worldwide. Pulmonary sepsis can be of sufficient concern to physicians due to their noticeable symptoms, which usually rely less on screening tools.AimTo investigate the efficiency of the international normalized ratio (INR) for the early rapid recognition of adult nonpulmonary infectious sepsis.MethodsThis is a prospective observational study. A total of 108 sepsis patients and 106 nonsepsis patients were enrolled according to relevant inclusion and exclusion criteria. Commonly used clinical indicators, such as white blood cell, neutrophil count, lymphocyte count, neutrophil-lymphocyte count ratio (NLCR), platelets (PLT), prothrombin time, INR, activated partial thromboplastin time, and quick Sequential "Sepsis-related" Organ Failure Assessment (qSOFA) scores were recorded within 24 h after admission. The diagnostic performances of these clinical indicators were analyzed and compared through multivariate logistic regression analysis, Spearman correlation, and receiver operating characteristic curve analysis.ResultsThe INR value of the sepsis group was significantly higher than that of the nonsepsis group. INR has superior diagnostic efficacy for sepsis, with an area under the curve value of 0.918, when those preexisting diseases which significantly affect coagulation function were excluded. The diagnostic efficacy of the INR was more significant than that of NLCR, PLT, and qSOFA (P < 0.05). Moreover, INR levels of 1.17, 1.20, and 1.22 could be used to categorize the relative risk of nonpulmonary infections sepsis into three categories: low, medium and high risk, respectively.ConclusionThe INR is a promising and easily available biomarker for diagnosis, and it can be used as one of the indicators for early screening of adult nonpulmonary infectious sepsis. When its value is higher than the optimal cutoff value (1.22), high vigilance is required for adult nonpulmonary infectious sepsis.

Dataset Information

Thrombolysis in stroke patients: Comparability of point-of-care versus central laboratory international normalized ratio.

Publications

Thrombolysis in stroke patients: Comparability of point-of-care versus central laboratory international normalized ratio.

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