Mirta Hepner

Mario Negri Institute for Pharmacological Research

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Gabriela Sciuccati

Garrahan Hospital

Juan Pablo Frontroth

Garrahan Hospital

Graciela Pieroni

Garrahan Hospital

Aurora Feliú Torres

Garrahan Hospital

Mariana Bonduel

Garrahan Hospital

M. Bonduel

Garrahan Hospital

Sílvia Tenembaum

Garrahan Hospital

Christoph Bidlingmaier

Ludwig-Maximilians-Universität München

Ayala Maayan‐Metzger

Edmond and Lily Safra Children's Hospital

Anthony K.C. Chan

McMaster Children's Hospital

Cooperative Institutions

Garrahan Hospital

Hospital for Sick Children

Sheba Medical Center

Tel Aviv University

University of Toronto

SickKids Foundation

Instituto Nacional de Pediatria

München Klinik

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Edmond and Lily Safra Children's Hospital

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PB0668 Emicizumab Treatment Regimen Based on Vial Size Along with Quantification of Emicizumab Plasma Concentration. Real-World Experience from a Single Pediatric Center in Argentina

Research and Practice in Thrombosis and Haemostasis (2023)

Gabriela Sciuccati R. Sueldo Carolina Cervio Margherita Bianco Juan Pablo Frontroth

demonstrating treatment safety in routine clinical practice.

Vial

Center (category theory)

Regimen

Single Center

10.1016/j.rpth.2023.101165

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Validación de un método para la cuantificación plasmática de emicizumab

Revista Hematología (2024)

R. Sueldo E Annetta Juan Pablo Frontroth Carolina Cervio B Bianco

Introducción: El emicizumab (Hemlibra®, ROCHE) es un anticuerpo monoclonal IgG4 bi-específico, recombinante y humanizado, que mimetiza la función del FVIIIa. Su administración por vía subcutánea es eficaz y segura en la prevención de hemorragias en pacientes con hemofilia A severa con o sin inhibidor. Si bien el emicizumab ha sido aprobado con un régimen de administración basado en el peso corporal y sin un monitoreo de los niveles plasmáticos, la cuantificación plasmática de emicizumab puede ser útil en distintas circunstancias clínicas y de investigación. Debido a que en Argentina aún no están disponibles los calibradores y controles comerciales específicos de emicizumab, hemos validado un método para la cuantificación plasmática de emicizumab (Epc), basado en la medición de FVIII por método coagulométrico en una etapa modificado (modFVIIIcoag), utilizando calibradores y controles preparados “in-house”. Materiales y métodos: para la Epc se utilizó una predilución de la muestra 1/80 con buffer Owren Koller. El calibrador “in-house” de emicizumab (150 μg/mL de emicizumab) se preparó agregando emicizumab de 150 mg/ml a un plasma deficiente en FVIII. Se prepararon dos niveles de control “in-house” y una curva de calibración de 6 puntos. Los procedimientos de validación se realizaron en un STA Compact Max2 (Diagnostica Stago). Repetibilidad: se procesaron los controles 20 veces en la misma corrida analítica. Imprecisión Intra-Laboratorio: se procesaron los controles por triplicado durante 5 días. Linealidad:11 niveles medidos por triplicado. Límite de cuantificación: 15 mediciones de un plasma deficiente de FVIII comercial. Bias: a partir de un programa de evaluación externa de calidad (UK NEQAS). Se evaluó la interferencia del FVIII y rFVIIa en Epc, y de emicizumab en otras determinaciones de hemostasia. Resultados: Epc mostró una imprecisión y un sesgo aceptables, un rango lineal de 5-150 μg/ml y un límite de cuantificación de 5 μg/ml de emicizumab. En los estudios de interferencia se encontró que el FVIII interfiere con Epc pero no así el rFVIIa. Emicizumab acortó los valores del TTPa por debajo del límite inferior del intervalo de referencia local, mientras que el FVIII medido por método cromogénico con componentes de origen bovino no fue afectado. El método coagulométrico de una etapa de FVIII fue falsamente aumentado y mostró una fuerte correlación lineal con Epc en este sistema reactivo/instrumento. Discusión: El ensayo modFVIIIcoag automatizado “in-house” permite la cuantificación plasmática de emicizumab mediante un método sencillo, reproducible, de bajo costo y de fácil integración en los procesos de rutina.

10.48057/hematologa.v27i3.551

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Subject Index Vol. 115, 2006

Acta Haematologica (2006)

Mariana Bonduel Leonardo R. Brandão Nagina Parmar Lesley Mitchell Leslie R. Berry

10.1159/000092175

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Platelet aggregation and adenosine triphosphate release values in children and adults

Journal of Thrombosis and Haemostasis (2007)

M. Bonduel Juan Pablo Frontroth Mirta Hepner Gabriela Sciuccati Aurora Feliú-Torres

Adenosine triphosphate

Adenosine diphosphate

10.1111/j.1538-7836.2007.02621.x

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Citations (26)

Title Page / Table of Contents

Acta Haematologica (2006)

Mariana Bonduel Leonardo R. Brandão Nagina Parmar Lesley Mitchell Leslie R. Berry

Table (database)

10.1159/000092172

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Factor V leiden and prothrombin gene G20210A mutation in children with cerebral thromboembolism

American Journal of Hematology (2003)

Mariana Bonduel Gabriela Sciuccati Mirta Hepner Graciela Pieroni Aurora Feliú Torres

We investigated whether there is an association between factor V Leiden (FVL) and/or prothrombin gene G20210A mutation (PT20210A) and cerebral thromboembolism in a pediatric Argentinean population. From May 1992 to January 2002, 44 consecutive children with arterial ischemic stroke (AIS) and 23 children with cerebral sinovenous thrombosis (SVT) were prospectively studied at a single center. The prevalence of both mutations was compared with a 102 age-matched controls. In children with AIS, the frequencies (patients vs. controls), odds ratio (OR), and 95% confidence interval (95% CI) for the presence of FVL were as follows: 2.3% vs. 2%, OR/95% CI, 1.16/0.2 to 13.2; P value = 0.99. No cases of PT20210A were found in this group. In children with SVT, the frequencies (patients vs. controls), OR, and 95% CI were as follows: FVL (4.3% vs. 2%, OR/95% CI, 2.27/0.22 to 6.2; P value = 0.99) and PT20210A (4.3% vs. 1%; OR/95% CI, 4.6/0.3 to 76.3; P value = 0.3354). One child with PT20210A also had an inherited protein C deficiency. In 12 (18%) out of the 67 children with cerebral thromboembolism, without the aforementioned mutations, other prothrombotic disorders were detected. Although a multi-center prospective study with a large number of Argentinean pediatric patients is needed to obtain considerable evidence, no association between factor V Leiden and/or prothrombin gene G20210A mutation and cerebral thromboembolism was found in this pediatric series.

Prothrombin G20210A

Factor V

Stroke

10.1002/ajh.10326

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Citations (67)

Acenocoumarol therapy in pediatric patients

Journal of Thrombosis and Haemostasis (2003)

M. Bonduel Gabriela Sciuccati Mirta Hepner Aurora Feliú Torres Graciela Pieroni

Acenocoumarol

Regimen

Maintenance dose

Loading dose

10.1046/j.1538-7836.2003.00256.x

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Citations (24)

PB0288 Antiphospholipid Syndrome in Children: 30 Years Single-Center Prospective Pediatric Cohort from Argentina

Research and Practice in Thrombosis and Haemostasis (2023)

Carolina Cervio E Annetta B Bianco Emanuel Sueldo Juan Pablo Frontroth

Aims: To assess stroke recurrence and bleeding complications in three pediatric AIS cases treated with rivaroxaban.Methods: A case series review of three pediatric AIS patients treated with rivaroxaban at a single institution.Results: Three male children (median age: 11) with acute AIS caused by different etiologies were treated at our institution.Demographics, stroke characteristics, and initial treatments are summarized in Table 1.Endovascular thrombectomy or intravenous tissue plasminogen activator were used in two cases, but the third was ineligible due to the infectious etiology of his stroke.All three were initially treated with unfractionated heparin (UFH), followed by enoxaparin in two patients, before DOAC initiation.All three received rivaroxaban (median time from stroke to DOAC start: 18 days) and all three remained on rivaroxaban for at least 3 months without stroke recurrence.Easy bruising and epistaxis were noted in one patient.Parenchymal petechial hemorrhages were noted in one patient prior to DOAC initiation without progression/worsening on follow up scans (Table 2). Conclusion(s):In this case series, three pediatric AIS patients were successfully treated with rivaroxaban without any serious bleeding complications.After a median follow up of 6 months, no recurrent strokes have been observed and all three patients showed improvement in arterial flow on follow up imaging.Larger studies are needed to further assess the safety and effectiveness of rivaroxaban in pediatric AIS.

Single Center

Center (category theory)

10.1016/j.rpth.2023.101420

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Suspected Allergy to Warfarin: A Management Approach Based on Experience

Journal of Allergy and Clinical Immunology (2010)

Lopez Zepeda L Mirta Hepner DP Doshi Carl B. Lauter

10.1016/j.jaci.2009.12.602

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Citations (2)

Protein C