Blasting the myth of predictive INR changes related to plasma transfusion: an academic institution's experience

Abstract Introduction Plasma transfusion is a common therapeutic strategy used to lower international normalized ratio (INR) values in the non-emergent setting. However, due to lack of evidence of its efficacy, standardized guidelines for this practice have not been well established. Methods This retrospective observational cohort study analyzed 276 inpatient encounters that involved plasma transfusions focusing on change in INR values from pre- to post-transfusion, with respect to the following predictor variables: vitamin K co-administration, number of plasma units transfused, order indication and body mass index (BMI). Results The overall average change in the INR was 1.35. Patients who received vitamin K showed an average change of 2.51, while patients that did not receive vitamin K demonstrated an average change of 0.70. Increased numbers of plasma units transfused showed benefit up to three-unit orders. Greater decreases in the INR were observed for patients requiring plasma for anticoagulation reversal or active bleeding. There was no significant difference in the change in INR based on the BMI. By multivariate and regression analyses, the stepwise addition of each successive predictor variable demonstrated an increase in the shared variance in the outcome of the post-transfusion INR: the pre-transfusion INR and vitamin K co-administration alone was not significant (p= 0.45); the additional number of plasma units transfused was significant (R² = 0.13, p < 0.001), and; the subsequent additional plasma order indications (R² = 0.19, p < 0.001) and BMI (R² = 0.18, p < 0.001) were increasingly significant. Conclusion Taking into consideration the combination of multiple predictive factors may aid in a more efficient use of plasma products.

Development and validation of a mobile application based on a machine learning model to aid in predicting dosage of vitamin K antagonists among Indian patients post mechanical heart valve replacement

Patients who undergo heart valve replacements with mechanical valves need to take Vitamin K Antagonists (VKA) drugs (Warfarin, Nicoumalone) which has got a very narrow therapeutic range and needs very close monitoring using PT-INR. Accessibility to physicians to titrate drugs doses is a major problem in low-middle income countries (LMIC) like India. Our work was aimed at predicting the maintenance dosage of these drugs, using the de-identified medical data collected from patients attending an INR Clinic in South India. We used artificial intelligence (AI) - machine learning to develop the algorithm. A Support Vector Machine (SVM) regression model was built to predict the maintenance dosage of warfarin, who have stable INR values between 2.0 and 4.0. We developed a simple user friendly android mobile application for patients to use the algorithm to predict the doses. The algorithm generated drug doses in 1100 patients were compared to cardiologist prescribed doses and found to have an excellent correlation.

Development of an interview-based warfarin nomogram predicting the time spent in the therapeutic INR range: A cost-effective, and non-invasive strategy building from a cross sectional study in a low resource setting

A cross-sectional study was conducted to predict time in therapeutic range (TTR) using clinical history, examination, and socioeconomic data. Study included warfarin-receiving patients from outpatient-clinic. In 203 patients studied, mean warfarin start-dose was 2.55 mg/day and maintenance-dose/week was 30.79 mg. Body mass index (BMI) (p ¼ 0.03), warfarin maintenance dose/day (p ¼ 0.02), and comorbidity presence (p ¼ 0.04) were significantly associated with TTR. Occupation (p ¼ 0.53), income (p ¼ 0.83), education (p ¼ 0.55), and socioeconomic score (p ¼ 0.73) showed non-significant association with TTR. A TTR predicting nomogram was built from clinical history and examination findings.

Epidural Analgesia and Abnormal Coagulation in Patients Undergoing Minimal Invasive Repair of Pectus Excavatum

Background:Epidural analgesia (EA) is effective in patients undergoing minimal invasive repair of pectus excavatum(MIRPE) but is associated with major complications such as epidural hematomas. It is recommended to assess coagulation status in patients receiving anticoagulant therapy prior to EA, although no consensus exists in patients without a history of bleeding tendency or anticoagulant therapy. Thus, the aim of this paper was to assess 1) the prevalence of abnormal routine coagulation parameters, i.e., international normalized ratio (INR) and platelet count, and 2) the safety of EA in patients undergoing MIRPE. Methods: In this retrospective study, we identified 1,973 patients undergoing MIRPE at our center between 2001 and 2019. Complications related to EA were registered for all patients. Information on coagulation parameters was present in 929 patients. Patients with spontaneously elevated INR ?1.5 were referred for assessment of coagulation factor VII in order to assess the cause of the elevated INR. Results: Of 929 patients with coagulation information available, 18 patients had spontaneously elevated INR ?1.5 (1.9%). In patients with INR ?1.5, 12 patients underwent further assessment of factor VII, with all patients having a slightly reduced factor VII close to the lower reference range. The majority of the 1,973 patients undergoing MIRPE received EA (99.6%) with very low complication rates (0.2%) and no incidence of epidural hematomas. Conclusion: In patients undergoing MIRPE, coagulation screening prior to EA should not be mandatory as it revealed no clinically relevant consequences. EA is safe with very low complication rates

Estandarización del índice internacional normalizado en pacientes pre-quirúrgicos del Hospital San Juan de Dios de Cuenca / Standarization of the Internacional Normalized Index in pre-surgical patients at Hospital San Juan de Dios of Cuenca / Padronização do Índice Normalizado Internacional em pacientes pré-cirúrgicos do Hospital San Juan de Dios em Cuenca

El índice internacional normalizado (INR, por sus siglas en inglés), es un tipo de cálculo matemático que se basa en las pruebas de tiempo de protrombina. La seguridad y eficacia de la terapia dependen del efecto anticoagulante que reciban dentro del margen terapéutico fijado por el médico en base al estudio de sus tiempos de coagulación, específicamente expresado como el intervalo de INR. Establecer los rangos de referencia del INR aplicado en resultados obtenidos en pacientes del sexo masculino y femenino en edades entre los 18 hasta 60 años de edad en el Hospital San Juan de Dios de Cuenca, durante los meses de enero a junio del año 2021. Los datos fueron recopilados de 699 pacientes que acudieron a consulta externa del Hospital San Juan de Dios de Cuenca del área de hematología, que incluyen valores de tiempo de tromboplastina y su referente INR en base al ISI establecido en el reactivo emitido por el fabricante. Se establecieron los valores normales de INR los cuales varían en referencia al sexo del paciente. Para el sexo masculino valores con límite inferior 0,82 y límite superior 1,16; para el sexo femenino con límite inferior de 0,51 y el límite superior de 1,51. Los valores de INR tienen variaciones de acuerdo al sexo siendo los valores de hombres mas altos en relación al de las mujeres en el rango inferiores, Evidentemente los factores influyentes van en relación del sexo, edad, dieta y sobretodo la genética del paciente.

The International Normalized Ratio (INR) is a type of mathematical calculation based on prothrombin time testing. The safety and efficacy of therapy depend on the anticoagulant effect they receive within the therapeutic range set by the physician based on the study of their clotting times, specifically expressed as the INR range. To establish the reference ranges of the INR applied in results obtained in male and female patients between 18 and 60 years of age at the San Juan de Dios Hospital in Cuenca, during the months of January to June 2021. The data were collected from 699 patients who attended the outpatient clinic of the Hospital San Juan de Dios de Cuenca in the hematology area, including thromboplastin time values and their INR referent based on the ISI established in the reagent issued by the manufacturer. Normal INR values were established, which vary according to the patient's sex. For the male sex values with a lower limit of 0.82 and an upper limit of 1.16; for the female sex with a lower limit of 0.51 and an upper limit of 1.51. The INR values vary according to sex, with the values for men being higher in relation to those for women in the lower range. Evidently, the influencing factors are related to sex, age, diet and above all the patient's genetics.

A Relação Internacional Normalizada (INR) é um tipo de cálculo matemático baseado em testes de tempo de protrombina. A segurança e eficácia da terapia depende do efeito anticoagulante que recebem dentro da faixa terapêutica estabelecida pelo médico com base no estudo de seus tempos de coagulação, expressa especificamente como a faixa INR. Estabelecer as faixas de referência do INR aplicadas em resultados obtidos em pacientes do sexo masculino e feminino com idade entre 18 e 60 anos no Hospital San Juan de Dios em Cuenca, durante os meses de janeiro a junho de 2021. Os dados foram coletados de 699 pacientes que compareceram ao ambulatório do Hospital San Juan de Dios de Cuenca na área de hematologia, incluindo os valores de tempo de tromboplastina e sua referência INR baseada no ISI estabelecido no reagente emitido pelo fabricante. Foram estabelecidos valores normais de INR, que variam de acordo com o sexo do paciente. Para o sexo masculino, com um limite inferior de 0,82 e um limite superior de 1,16; para o sexo feminino, com um limite inferior de 0,51 e um limite superior de 1,51. Os valores de INR variam de acordo com o sexo, sendo os valores para os homens maiores em relação àqueles para as mulheres na faixa inferior. Evidentemente, os fatores de influência estão relacionados ao sexo, idade, dieta e, acima de tudo, à genética do paciente.

Analysis of Anticoagulation Therapy Related Complications in Patients With Prosthetic Valves: Our Experience

Purpose:The aim of this study is to analyze anticoagulation?related complications in patients following mechanical valve replacement and factors influencing the outcome. Materials and Methods: A total of 250 patients were analyzed during OPD follow?up for anticoagulation?related complications and various factors influencing outcome. Patients received prosthetic valve at mitral and/or aortic or both. Results: Out of 250 patients, 48% were male and 52% were female. The mean age was 41.9 ± 14.4. A total of 139 had mitral valve replacement (MVR), 70 had aortic valve replacement (AVR), 40 had double valve replacement (DVR), and 1 patient had triple valve replacement. Valves implanted were mechanical bileaflet valve. The mean international normalization ratio (INR) in the study was 2.4 ± 0.56. A total of 49 events occurred during follow?up, of which 4.5% per patient years were anticoagulation?related hemorrhagic events and 4.8% per patient years were thromboembolic events. Among thromboembolic events, valve thrombosis occurred in 10 patients and cerebrovascular accidents occurred in 11 patients. Mean INR for thromboembolic events was 1.46 ± 0.25 and anticoagulation?related hemorrhagic events was 4.4 ± 1.03. Mortality rate was 1.6% in AVR, 4% in MVR, and 0.4% in DVR? groups; about 34% of patients needed dose modification of Acenocoumarol and reason for derangement of INR was associated with infectious process and poor compliance; 85% of cases showed good compliance for daily anticoagulation therapy. Conclusion: Anticoagulation for mechanical valve replacement can be managed with INR range of 2.0 to 2.5 in MVR and 1.5 to 2.0 in AVR with acceptable hemorrhagic and thromboembolic events. We must educate and counsel the patients during follow?up for better compliance to optimal anticoagulation.

Evolución del grado de control de una cohorte de pacientes anticoagulados de Atención Primaria / Evolution of the degree of control in a cohort of anticoagulated patients in Primary Care

Introducción: Solo el 60 por ciento de los pacientes en tratamiento con antagonistas de la vitamina K (AVK) están controlados. Objetivos: A nalizar una cohorte de pacientes anticoagulados para valorar su grado de control y su evolución a los 2 años, tras una intervención formativa breve. Métodos: Estudio longitudinal, observacional, retrospectivo de 157 anticoagulados con AVK. Se recogieron datos sociodemográficos, comorbilidades, motivo de prescripción del AVK y grado de control basal y tras 2 años de seguimiento. Utilizamos 2 métodos de valoración diferentes: Rosendaal y método directo (porcentaje de INR-Razón Normalizada Internacional- en rango). Asimismo, establecimos correlaciones temporales intramétodo. Resultados: El grado de control pasó del 47,3 por ciento al 53,5 por ciento a los 2 años, según Rosendaal (p= 0,52), y del 39,5 por ciento al 53,5 por ciento según el método directo (p< 0,05). El tiempo en rango terapéutico fue del 63,1 ±19,9 por ciento al inicio y 65 ±19,2 por ciento al final del seguimiento. La correlación entre los 2 controles fue positiva para ambos métodos (Rosendaal: 0,23; método directo: 0,33). El análisis multivariante fue significativo para el sexo masculino y para un objetivo diferente de 2,5-3,5 (odds ratio: 2,22 y 2,73, respectivamente). Conclusiones: El control del INR mejoró a los 2 años de seguimiento tras la actividad formativa. La evolución del grado de control de cada paciente es parcialmente predecible. El peor control se asoció al sexo femenino y al objetivo de INR de 2,5-3,5. El control mejora 2,22 veces en los varones y 2,73 veces en quienes no tienen un INR objetivo de 2,5-3,5(AU)

Introduction: Only 60 percent of patients on treatment with vitamin K antagonists (AVK) are controlled. Objectives: We proposed to analyze a cohort of anticoagulated patients to assess their degree of control and their evolution at 2 years, after a brief training intervention. Methods: Longitudinal, observational, retrospective study of 157 anticoagulated with AVK. Sociodemographic data, comorbidities, reason for VKA prescription and degree of baseline control were collected and after 2 years of follow-up. We use 2 different valuation methods: Rosendaal and direct method (INR percentage -International Normalized Ratio- in range). Likewise, we established intra-method temporal correlations. Results: The degree of control went from 47.3 percent to 53.5 percent at 2 years, according to Rosendaal (p = 0.52), and from 39.5 percent to 53.5 percent according to the direct method (p<0.05). The time in the therapeutic range was 63.1±19.9 percent at the start and 65±19.2 percent at the end of the follow-up. The correlation between the 2 controls was positive for both methods (Rosendaal: 0.23; direct method:0.33). The multivariate analysis was significant for males and for a target other than 2.5-3.5(odds ratio: 2.22 and 2.73, respectively). Conclusions: INR control improved after 2 years of follow-up after training activity. The evolution of the degree of control of each patient is partially predictable. The worst control was associated with female sex and the INR goal of 2.5-3.5. Control improves 2.22 times in males and 2.73 times in those without a target INR of 2.5-3.5(AU)

Intoxicación por rodenticidas (raticidas) con superwarfarinas efecto anticoagulante altamente prolongado

Joven de 19 años que realiza intento de suicido en febrero de 2019, ingiriendo 04 bolsas de raticida "Klerat". Llevado a Emergencia en la ciudad de Tarapoto (Región San Martín); le realizan lavado gástrico; recibe Fitomenadiona 2 dosis y lo envían a su casa. A los 11 días post- intoxicación presenta dolores osteomusculares, orina de color rojizo, se añade sangrado por las encías, epistaxis, hematomas, aumenta la gingivorragia y sensación de desvanecimiento; es llevado al Hospital de Yurimaguas. En los exámenes de laboratorio se encuentra: INR:9.7 y alteraciones en el Tiempo de Protrombina (TP):45 y Tiempo de Tromboplastina Parcial activada (TTPA): 60. Recibe tratamiento con Fitomenadiona y Ácido tranexámico. Por persistir gingivorragia escasa y alteraciones en la coagulación se hace la referencia al hospital Nacional Dos de Mayo de la ciudad de Lima. Donde se encuentra: INR: 11.5, TP:120 seg. TTPA: 86.5, Hb:12.2 Leucocitos:10.090 Plaquetas: 320.000, Orina: hematíes 5xc. Leucocitos:0-1 x c. Perfil hepático: Normal, Perfil lipídico: Normal, Rx. de Tórax. Normal, Dímero D: 0.14. Se realizan Pruebas de autoinmunidad, encontrando el Anticoagulante Lúpico: Positivo, siendo el resto de pruebas negativas. Se dio Tto. con Plasma Fresco congelado, crioprecipitados y Fitomenadiona. El examen de orina en CICOTOX encontró metabolitos de hidroxicumarinas POSITIVO. Estuvo hospitalizado por 2 meses, se logra la estabilización en el perfil de coagulación y el INR; dependientes del Tto. con Fitomenadiona. El control de orina en CICOTOX dio negativo a los 2 meses. El control del anticoagulante Lúpico a los 3 meses dio Positivo; a los 6 meses dio Negativo. Tuvo que continuar con Tto. de Fitomenadiona por 10 meses más (dic. 2019), hasta lograr la estabilización total del perfil de coagulación y el INR. Para darle el Alta.

Consenso argentino en gestión efectiva de clínicas de anticoagulación para uso de antagonistas de la vitamina K / Argentine consensus in effective management of anticoagulation clinics for the use of vitamin K antagonists

Resumen El tratamiento de un paciente anticoagulado con antagonistas de la vitamina K (AVK) sigue siendo un desafío, especialmente en regiones donde, por el costo, los dicumarínicos son todavía la alternativa más buscada a la hora de elegir un anticoagulante oral. Las clínicas de anticoagulación han demostrado ser la forma más eficiente y segura de evitar complicaciones trombóticas y hemorrágicas y de mantener al paciente en rango óptimo de tratamiento. Sin embargo, requieren de una adecuada infraestructura y personal capacitado para que funcionen eficientemente. En este consenso argentino se propone una serie de parámetros para la gestión efectiva de una clínica de anticoagulación. El objetivo es lograr una elevada calidad desde el punto de vista clínico-asistencial a través de un laboratorio de hemostasia de excelencia. Los criterios desarrollados en el documento fueron consensuados por un amplio grupo de expertos especialistas en hematología y en bioquímica de todo el país. Estos criterios deben adaptarse a la irregular disponibilidad de recursos de cada centro, pero siempre se los debe tener en cuenta a la hora de indicar el tratamiento anticoagulante con estas drogas. Tener en consideración estas premisas nos permitirá optimizar la atención del enfermo anticoagulado con AVK y de esta forma minimizar las intercurrencias trombóticas y hemorrágicas a las que está expuesto, para así honrar nuestra promesa de no dañar al paciente.

Abstract Treating an anticoagulated patient with vitamin K antagonists (VKA) remains a challenge, especially in areas where dicoumarins are still the first drug of choice due to the cost of other oral anticoagulants. Anticoagulation clinics have proven to be the most efficient and safe way to avoid thrombotic and hemorrhagic complications and to keep patients in optimal treatment range. However, they require adequate infrastructure and trained personnel to work properly. In this Argentine consensus we propose a series of guidelines for the effective management of the anticoagulation clinics. The goal is to achieve the excellence in both the clinical healthcare and the hemostasis laboratory for the anticoagulated patient. The criteria developed in the document were agreed upon by a large group of expert specialists in hematology and biochemistry from all over the country. The criteria presented here must always be considered when indicating VKA although they had to be adapted to the unequal reality of each center. Taking these premises into consideration will allow us to optimize the management of the anticoagulated patient with VKA and thus minimize thrombotic and hemorrhagic intercurrences, in order to honor our promise not to harm the patient.

Correlation Study of Coagulation Profile in Spectrum of Liver Diseases.

Liver plays a central role in the maintenance of haemostasis. Impairment of liver parenchymal cell function disturbs haemostasis resulting in the development of multiple coagulation abnormalities. We wanted to study the coagulation profile and haemostatic dysfunction in liver disease patients so as to prevent bleeding related complications and evaluate the relationship between bleeding tendencies and coagulation profile abnormalities in such patients.METHODSThis was a cross sectional study conducted in the Department of Pathology, JNMC, A.V.B.R.H, Sawangi, Wardha, from August, 2017 to July 2019 among 102 patients of liver diseases. PT, D-dimer, and platelet count were assessed in different liver diseases. Data was entered in MS Excel spreadsheet and analysis was done using Statistical Package for Social Sciences (SPSS) version 21.0. A p value of <0.05 was considered statistically significant.RESULTSA total of 102 patients were included in the study. Mean age of the patients was 40.07 ± 15.21 years. 69.61% patients were males. Fever with abdominal distension was the most common complaint. Mean with SD of Child Pugh score was 8.31±2.3 and Mean with SD of MELD score was 13.1±8.24. For predicting cirrhosis and other chronic liver disorders, out of all coagulation parameters, D-Dimer showed the best diagnostic accuracy.CONCLUSIONSPresent study showed an overall good diagnostic power of coagulation parameters in assessing different liver diseases and also showed that D-dimer may be regarded as a stable and good predictor for chronic liver diseases.

Relação entre parâmetros hemostáticos, evolução clínica e desfecho de pacientes diagnosticados com sepse / Relationship between hemostatic parameters, clinical evolution and outcome of patients diagnosed with sepsis

Sepse é definida como uma resposta inflamatória sistêmica frente a um microrganismo, sendo uma das principais causas de morte em pacientes internados em unidades de terapia intensiva (UTI). Na sepse, a cascata de coagulação é ativada, contribuindo na formação de tromboembolismo venoso localizado e coagulação intravascular disseminada, uma das responsáveis pela síndrome da disfunção orgânica múltipla; além disso, o consumo de plaquetas e de proteínas de coagulação pode resultar em hemorragias graves. Pacientes com sepse internados em UTI têm como principais prestadores de assistência a equipe de enfermagem que pode ter suas atividades organizadas pela Sistematização da Assistência de Enfermagem (SAE). A SAE possibilita perspectivas em relação ao cuidado, guia e normatiza mais precisamente a assistência de enfermagem direcionando a resolução dos problemas dos pacientes, pois mobiliza competências profissionais específicas no cuidado, resultando na qualidade da assistência. Esse estudo objetivou avaliar a relação de dois componentes do sistema hemostático (contagem de plaquetas e International Normalized Ratio - INR) com a gravidade clínica e com o desfecho em pacientes diagnosticados com sepse internados na UTI. Trata-se de um estudo quantitativo, exploratório e correlacional no qual os dados foram coletados de maneira pregressa. O estudo desenvolveu-se num hospital público de cuidados de alta complexidade em nível ambulatorial e hospitalar, por meio da análise de prontuários de pacientes diagnosticados com sepse internados na UTI no período de janeiro a dezembro de 2017. As variáveis relacionadas às características sócio- demográficas, clínicas e o tempo de assistência de enfermagem foram coletadas do prontuário eletrônico dos pacientes utilizando-se formulário específico. Foram incluídos 176 prontuários. Não foram observadas diferenças estatisticamente significantes em relação ao sexo, idade ou raça dos pacientes, contudo, os resultados mostram que pacientes com desfecho óbito apresentaram piores valores dos parâmetros clínicos e laboratoriais, demandaram mais cuidados de enfermagem e apresentaram contagem de plaquetas menor e INR maior do que os pacientes que tiveram alta; além disso, observou-se que a contagem de plaquetas <100.000 mm3 e o INR>1,5 estão associados à maior frequência do desfecho óbito. Foi analisada a capacidade da contagem de plaquetas e do INR para predizerem o óbito por meio de uma curva ROC que indicaram a contagem de plaquetas como um preditor não adequado e o INR um preditor fraco para o desfecho óbito. Assim, este estudo mostrou que os pacientes diagnosticados com sepse que foram a óbito apresentaram maior comprometimento orgânico e demandaram mais cuidados de enfermagem do que aqueles que tiveram como desfecho a alta hospitalar, além disso, a contagem de plaquetas e o INR indicam um comprometimento do sistema hemostático, sinalizando um quadro fibrinolítico. Tanto a contagem de plaquetas quanto o INR foram associados ao óbito, no entanto, não se mostraram bons preditores para tal. O dimensionamento do trabalho de enfermagem utilizando o NAS, a avaliação dos exames laboratoriais e da gravidade através dos SAPS 3, realizados pelo enfermeiro com conhecimento específico, facilita a elaboração e evolução da SAE. Quanto mais dados, mais acurada a análise, levando a modificações do planejamento da assistência de enfermagem

Sepsis is defined as a systemic inflammatory response to a microorganism, being a major cause of death in intensive care unit (ICU) patients. In sepsis, the coagulation cascade is activated, contributing to the formation of localized venous thromboembolism and disseminated intravascular coagulation, one of the causes of multiple organ dysfunction syndrome. In addition, the consumption of platelets and coagulation proteins may result in serious bleeding. Patients with sepsis admitted to the ICU have, as their main care providers, the nursing staff that may have their activities organized by the Nursing Care Systematization (NCS). NCS provides perspectives regarding care, guides and regulates more precisely nursing care, directing the resolution of patients' problems, as it mobilizes specific professional skills in care, resulting in the quality of care. This study aimed to evaluate the relationship of two components of the hemostatic system (platelet count and International Normalized Ratio - INR) with clinical severity and outcome in patients diagnosed with ICU sepsis. This is a quantitative, exploratory and correlational study in which data were previously collected. The study was developed in a public hospital of high complexity care at the outpatient and inpatient level through the analysis of medical records of patients diagnosed with sepsis admitted to the ICU from January to December 2017. The variables related to socio-demographic, clinical characteristics and length of nursing care were collected from the patients' electronic medical records using a specific form. We included 176 medical records. No statistically significant differences were observed regarding gender, age or race of patients; however, the results show that patients with death outcome had worse clinical and laboratory parameter values, required more nursing care and had lower platelet count and higher INR than patients who were discharged; in addition, platelet counts <100,000 mm3 and INR> 1.5 were associated with a higher frequency of death outcome. We analyzed the ability of platelet count and INR to predict death by means of a ROC curve that indicated platelet count as an inadequate predictor and INR as a weak predictor of death outcome. Thus, this study showed that patients diagnosed with sepsis who died had greater organic impairment and demanded more nursing care than those who were discharged from the hospital. In addition, the platelet counts and INR indicate a compromised hemostatic system, signaling a fibrinolytic picture. Both platelet count and INR were associated with death; however, they were not good predictors for it. The dimensioning of nursing work using the NAS, the evaluation of laboratory tests and severity on SAPS 3, performed by a nurse with specific knowledge, facilitates the elaboration and evolution of the NCS. The more data, the more accurate the analysis, leading to changes in nursing care planning

Quality and Superiority of Anticoagulation therapy in neurological patients in a tertiary care hospital

Background: Oral anticoagulation (OAC) is used in neurology practice for primary and secondary stroke prevention in atrial fibrillation (AF). Since, there are lacunae of literature on the quality of anticoagulation in neurological patients this study was planned. Objective: To Evaluate the quality of oral anticoagulation therapy in neurology patients. Materials and methods: A prospective study was conducted on patients attending tertiary care neurology OPD who were prescribed oral anticoagulant (OAC). Consecutive sampling technique was used. Their international normalized ratio (INR) values were prospectively observed and the earlier INR values of the patients who were already on OAC were retrospectively scrutinized. The level of anticoagulation, factors intrusive with OAC and complications were noted. Results: The results were based on 70 patients with median age 45 year. Fifty patients received OAC for secondary stroke prevention, 16 for cerebral venous sinus thrombosis (CVST) and four for deep vein thrombosis (DVT). Of the 1280 INR reports, 500 (39.5%) reports were in the therapeutic range, 496 (38.5%) were below and 280 (21.9%) were above the therapeutic level. Stable INR was obtained in 30 (42.86%) patients only. The overall complication rate was 16.4 per 100 person-years. Conclusions: In the present study, it was concluded that stable therapeutic INR is tough to maintain in neurological patients. Optimal modification of diet, drug and dose of oral anticoagulant may support in stabilization of INR.

Factores de riesgo en complicaciones tromboembólicas cerebrales de pacientes con fibrilación auricular permanente no valvular / Fatores de risco em complicações tromboembólicas cerebrais em pacientes com fibrilação atrial permanente não valvuvar / Risk factors in cerebral thromboembolic complications in patients with non-valvular permanent atrial fibrillation

Introducción: la fibrilación auricular es la arritmia cardiaca más frecuente que se trata en la práctica clínica y produce un 33 por ciento de las hospitalizaciones asociadas a arritmias. Objetivo: identificar factores de riesgo de complicaciones tromboembólicas cerebrales en pacientes con fibrilación auricular permanente no valvular y tratamiento anticoagulante oral entre los años 2015 y 2018. Método: se realizó un estudio de casos y controles en el Hospital General Docente "Dr. Agostinho Neto" en el periodo octubre entre 2015 y abril del 2018. El universo estuvo conformado 213 pacientes, 71 casos con fibrilación auricular permanente que sufrieron complicaciones tromboembólicas cerebrales bajo tratamiento con warfarina y 142 controles con fibrilación auricular permanente, con igual, pero sin las complicaciones antes mencionadas. Se seleccionaron dos controles por cada caso (2:1) para incrementar el poder estadístico del estudio. Se analizaron variables sociodemográficas, clínicas, ecocardiográficas, labilidad del INR (índice internacional normalizado) y adherencias terapéuticas. El análisis de los datos se presentó en tablas de datos de doble entrada. Se estimaron Chi cuadrado, intervalos de confianza y Odds ratio. Resultados: resultaron significativas el grupo de edad de 75 o más años, el sexo masculino, la hipertensión arterial, la presencia de placas de ateromas en aorta y carótidas, la diabetes mellitus, el INR subóptimo, la mala adherencia terapéutica. Conclusiones: el grupo etario de 75 o más años, sexo masculino, fumar, hipertensión arterial, diabetes mellitus, placas de ateroma en aorta y carótidas, INR subóptimo y mala adherencia terapéutica constituyen factores de riesgo significativos para la aparición de complicaciones tromboembólicas cerebrales(AU)

Introduction: atrial fibrillation is the most frequent cardiac arrhythmia that is treated in clinical practice and produces 33 percent of hospitalizations associated with arrhythmias. Objective: to identify risk factors for cerebral thromboembolic complications in patients with permanent nonvalvular atrial fibrillation and oral anticoagulant treatment between 2015 and 2018. Method: a case-control study was conducted in the General Teaching Hospital "Dr. Agostinho Neto" in the period October between 2015 and April 2018. The universe consisted of 213 patients, 71 cases with permanent atrial fibrillation who suffered cerebral thromboembolic complications under treatment with warfarin and 142 controls with permanent atrial fibrillation, with the same, but without the aforementioned complications. Two controls were selected for each case (2:1) to increase the statistical power of the study. We analyzed sociodemographic, clinical, echocardiographic variables, lability of the INR (international normalized index) and therapeutic adhesions. The analysis of the data was presented in double entry data tables. Chi square, confidence intervals and Odds ratio were estimated. Results: the age group of 75 or more years, the male sex, arterial hypertension, the presence of plaques of atheroma in the aorta and carotids, diabetes mellitus, suboptimal INR, poor therapeutic adherence were significant. Conclusions: the age group of 75 years or older, male sex, smoking, high blood pressure, diabetes mellitus, atheromatous plaques in the aorta and carotids, suboptimal INR and poor therapeutic adherence constitute significant risk factors for the appearance of cerebral thromboembolic complications(AU)

Introdução: a fibrilação atrial é a arritmia cardíaca mais frequente que é tratada na prática clínica e produz 33 por cento das internações associadas a arritmias. Objectivo: Para identificar os fatores de risco para as complicações tromboembólicas cerebrais em pacientes com não-valvular fibrilação atrial permanente e terapia anticoagulante oral, entre 2015 e 2018. Método: Um estudo de casos e controlos foi realizada no Hospital Universitario Dr. Agostinho Neto no período de outubro 2015 a abril de 2018. o grupo de estudo consistiu de 213 pacientes, 71 casos com fibrilação atrial permanente que sofreram sob cerebral complicações varfarina tromboembólica e 142 controles de fibrilação atrial permanente com igual, mas sem as complicações acima. Dois controles foram selecionados para cada caso (2:1) para aumentar o poder estatístico do estudo. Foram analisadas variáveis sociodemográficas, clínicas, ecocardiográficas, labilidade do INR (índice internacional normalizado) e adesões terapêuticas. A análise dos dados foi apresentada em tabelas de dados de dupla entrada. Qui-quadrado, intervalos de confiança e Odds ratio foram estimados. Resultados: foram grupo significativo idade de 75 anos, sexo masculino, a hipertensão, a presença de placas ateromatosas nas artérias aorta e carótida, diabetes mellitus, INR sub-óptima, a baixa adesão. Conclusões: o grupo de idade de 75 anos, sexo masculino, fumar, hipertensão, diabetes mellitus, placas aterosclericas na aorta e carótida, INR sub-tima e a fraca adesão constituem factores de risco importantes para a ocorrência de complicações tromboembólicas cerebrais(AU)

Assessment of clinical parameters among patients with snake poison induced coagulopathy

Background: Snakes are poikilothermic carnivorous reptiles that have evolved the venomous apparatus for the purpose of procurement of food. Snake bite can result in local and systemic complications. Major systemic complications include acute renal failure, neurologic abnormalities requiring ventilator support and disseminated intravascular coagulation. Disseminated intravascular coagulation can result in serious life-threatening systemic complications like haemorrhage, infarction and even death if the treatment is delayed. The present study was undertaken to study the clinical profile of the snake bite patients who develop coagulopathy and to study the role of coagulation markers to evaluate the morbidity and mortality of snake bite victims.Methods: Hundred patients consecutively admitted with history of snakebite were studied. Patients who have developed local signs of envenomation due to snake bite were included in the study group. The coagulation profile was assessed by doing blood investigations.Results: In this study, patients who developed coagulopathy had prolonged hospital stay and requirement of more blood products transfusion causing increased morbidity. 43 patients (35.8%) had platelets less than 1 lakh and approximately hospitalized for 26 days sand INR was more than 1.5 in 112 patients (93.3%) and hospitalized for 22 days and they received fresh frozen plasma. The survival rate in this study was 86% followed by 13.3% deaths.Conclusions: Use of clinical and laboratory parameter evaluation needed to identify the coagulopathy very early to reduce the hospital stay and mortality.

Cross sectional study on different doses of acenocoumarol with INR in a tertiary care hospital

Background: It is of high value to be assess the relationship between doses of Acenocoumarol and the INR values to offer better patient care. Since Acenocoumarol is a commonly used drug with a narrow therapeutic range it is essential to monitor the variations encountered in response to it to avoid drastic complications and to provide better health care. Aim: The aim of this study is to compare the INR values with different doses of Acenocoumarol, to compare the association of dose of Acenocoumarol with their respective INR and to find out the occurrence of bleeding with different doses of Acenocoumarol.Methods: The study was conducted in a Tertiary care hospital. 40 patients taking Acenocoumarol were recruited in the study. Relevant details like age, weight, dose of Acenocoumarol, INR and other concomitant drugs were obtained in a prospective manner. Correlation of dose of Acenocoumarol with respective INR was done by simple linear regression.Results: The relationship between dose and INR was analyzed using Simple linear regression and the scatter plot revealed no significant correlation between the dose and INR values. There is a lot of inter-individual variability in the dose response and thereafter the INR values.Conclusions: The dose of Acenocoumarol cannot predict INR values. Patient can ideally be started treatment on a low dose of Acenocoumarol and based on the INR values, dose can be titrated. There is a need for consideration of other factors which influence the dose and INR values.

Quality of Anticoagulation and Treatment Satisfaction in Patients with Non-Valvular Atrial Fibrillation Treated with Vitamin K Antagonist: Result from the KORean Atrial Fibrillation Investigation II

BACKGROUND: Vitamin K antagonist (VKA) to prevent thromboembolism in non-valvular atrial fibrillation (NVAF) patients has limitations such as drug interaction. This study investigated the clinical characteristics of Korean patients treated with VKA for stroke prevention and assessed quality of VKA therapy and treatment satisfaction. METHODS: We conducted a multicenter, prospective, non-interventional study. Patients with CHADS2 ≥ 1 and treated with VKA (started within the last 3 months) were enrolled from April 2013 to March 2014. Demographic and clinical features including risk factors of stroke and VKA treatment information was collected at baseline. Treatment patterns and international normalized ratio (INR) level were evaluated during follow-up. Time in therapeutic range (TTR) > 60% indicated well-controlled INR. Treatment satisfaction on the VKA use was measured by Treatment Satisfaction Questionnaire for Medication (TSQM) after 3 months of follow-up. RESULTS: A total of 877 patients (age, 67; male, 60%) were enrolled and followed up for one year. More than half of patients (56%) had CHADS2 ≥ 2 and 83.6% had CHA2DS2-VASc ≥ 2. A total of 852 patients had one or more INR measurement during their follow-up period. Among those patients, 25.5% discontinued VKA treatment during follow-up. Of all patients, 626 patients (73%) had poor-controlled INR (TTR < 60%) measure. Patients' treatment satisfaction measured with TSQM was 55.6 in global satisfaction domain. CONCLUSION: INR was poorly controlled in Korean NVAF patients treated with VKA. VKA users also showed low treatment satisfaction.

The clinical observation on the influence of combined use of allopurinol and warfarin on the INR of chronic permanent atrial fibrillation hyperuricemia patients / 中国生化药物杂志

Objective To investigate influence of combined use of allopurinol and warfarin on the INR of chronic permanent atrial fibrillation hyperuricemia patients. Methods 80 cases of patients with chronic atrial fibrillation complicated with hyperuricemia, in Sanmen County People's Hospital from February 2016 to February 2017 were randomly divided into the control group (n=40) and the observation group (n=40), the control group was given warfarin plus low purine diet treatment, the observation group was given additional Allopurinol treatment. Changes of INR were compared. Results There was no statistical significance in INR level before treatment between the two groups of patients with permanent atrial fibrillation complicated with chronic hyperuricemia. The INR level of the control group was not changed after treatment, the observation group increased significantly after treatment, and there was statistical significance between the two groups (P<0.05). There were no bleeding events in the control group, there were 6 cases of the observation group with minor bleeding and subcutaneous ecchymosis, including 2 cases with fecal occult blood, 1 cases with hematuria, nasal hemorrhage . The change of liver and kidney function was not obvious. Conclusion In application of allopurinol treatment plus warfarin for patients with chronic persistent atrial fibrillation and hyperuricemia patients, , INR need to be regularly monitored, in order to provide reference for Warfarin dosage adjustment, and ensure clinical safety.

The clinical observation on the influence of combined use of allopurinol and warfarin on the INR of chronic permanent atrial fibrillation hyperuricemia patients / 中国生化药物杂志

Objective To investigate influence of combined use of allopurinol and warfarin on the INR of chronic permanent atrial fibrillation hyperuricemia patients. Methods 80 cases of patients with chronic atrial fibrillation complicated with hyperuricemia, in Sanmen County People's Hospital from February 2016 to February 2017 were randomly divided into the control group (n=40) and the observation group (n=40), the control group was given warfarin plus low purine diet treatment, the observation group was given additional Allopurinol treatment. Changes of INR were compared. Results There was no statistical significance in INR level before treatment between the two groups of patients with permanent atrial fibrillation complicated with chronic hyperuricemia. The INR level of the control group was not changed after treatment, the observation group increased significantly after treatment, and there was statistical significance between the two groups (P<0.05). There were no bleeding events in the control group, there were 6 cases of the observation group with minor bleeding and subcutaneous ecchymosis, including 2 cases with fecal occult blood, 1 cases with hematuria, nasal hemorrhage . The change of liver and kidney function was not obvious. Conclusion In application of allopurinol treatment plus warfarin for patients with chronic persistent atrial fibrillation and hyperuricemia patients, , INR need to be regularly monitored, in order to provide reference for Warfarin dosage adjustment, and ensure clinical safety.

Interaction between Warfarin and Exenatide of One Diabetic Patient Complicated with Atrial Fibrillation / 中国药学杂志

OBJECTIVE: Blood tends to deposit in atrium to form thrombus in patients with atrial fibrillation. Patients with diabetes are in high coagulation state, for whom thrombosis is easy to occur. The number of diabetic patients with atrial fibrillation is large. Warfarin is one of the most widely used oral anticoagulants, which can cause major or fatal bleeding, so it is necessary to perform regular monitoring of international normalized ratio (INR) on all patients treated with warfarin. New kinds of antidiabetic drugs are widely used in clinic, among which a lot affect INR levels achieved with warfarin therapy. Clinical pharmacists should pay attention to drug interactions and monitor adverse drug reactions. As a new antidiabetic drug, exenatide has less reports of interaction with warfarin. The characteristic of the interaction between exenatide and warfarin was investigated, with the aim to optimize the rational and individualized medication. METHODS: A case was introduced in which exenatide was administrated combined with warfarin, so that the possible mechanism of exenatide affecting to warfarin were analyzed. RESULTS: INR declined from 2.13 to 1.57 after exenatide being added, and decreased further to 1.43 with concurrency of the increasing exenatide dose. On the contrary, INR was on rise as result of discontinuing exenatide. At last, INR returned to 1.78 when the patient discharged. CONCLUSION: Exenatide inhibited the absorption of warfarin, which lead to INR decline attributed to its effect of slowing down the gastric emptying. When exenatide and warfarin are combined, the dose of warfarin must be adjusted based on INR under clinical monitoring.

Change in Prothrombin Time International Normalized Ratio due to Drug Interaction between Celecoxib and Warfarin / 医薬品情報学

<b>Objective: </b>Celecoxib has been reported to enhance the action of warfarin by inhibiting CYP2C9, its major hepatic drug-metabolizing enzyme, but sufficient information about the mechanism has not been obtained, especially in Japan.<br><b>Methods: </b>A study was conducted to investigate the prothrombin time international normalized ratio (PT-INR) and the warfarin sensitivity index (WSI) before and after concurrent administration of celecoxib, as well as the Drug Interaction Probability Scale (DIPS) scores to determine causality with drug interactions, in patients commencing concurrent therapy with celecoxib and warfarin at Kanagawa Prefectural Keiyukai Keiyu Hospital during the 4-year period from October 2011 to September 2015.<br><b>Results: </b>Analysis of 18 patients showed that the PT-INR increased significantly from 1.53±0.43 before concurrent therapy to 2.18±1.01 after concurrent therapy (<i>p</i>=0.0101).  The WSI also increased significantly from 0.76±0.50 before concurrent therapy to 1.01±0.65 after concurrent therapy (<i>p</i>=0.0044).  According to the DIPS scores, the causal relation was not rated as “Highly Probable” in any of the patients, while it was considered to be “Probable” in 3 patients, “Possible” in 10 patients, and “Doubtful” in 5 patients.<br><b>Conclusion: </b>The findings of this study suggested that when celecoxib treatment is initiated in patients who are already taking warfarin, attention must be paid to changes of coagulation profile, especially in elderly patients.