ABSTRACT
Abstract Introduction Glanzmann thromboasthenia is a rare congenital bleeding disorder caused by a mutation in platelet glycoprotein α-IIb and β3 encoding genes (ITGA2B; 607759 and ITGB3; 173470) in chromosomes I7q21.31 and 17q21.32, respectively, which results in a qualitative or quantitative alteration of the platelet integrin αIIbβ3 (glycoprotein IIb/IIIa) receptor. Glanzmann thromboasthenia is classified as type I when less than 5% of glycoprotein αIIbβ3 is expressed, and as type II when more than 5% is expressed. Case presentation Description of the perioperative management of a 13-year-old female patient with Glanzmann thromboasthenia who underwent endoscopic anterior bilateral ethmoidectomy. Management was centered on prophylactic platelet transfusion plus the use of tranexamic acid, as well as thromboelastographic determination of hemostasis. There were no bleeding complications during or after the procedure. Conclusiones Pediatric patients with Glanzmann thromboasthenia are at a high risk of perioperastive bleeding. Platelet transfusion is the best prophylactic and therapeutic alternative; however, even in the absence of anti-platelet antibodies, it may not be effective, and viscoelastic testing must be used for assessment during the surgical procedure in order to improve patient safety.
Resumen Introducción La trombastenia de Glanzmann es un trastorno hemorrágico congénito infrecuente, causado por mutación en los genes que codifican las glucoproteínas plaquetarias α-IIb (ITGA2B; 607759) y β3 (ITGB3; 173470) en los cromosomas I7q2i.3i y I7q2i.32, respectivamente, alterando cualitativa o cuantitativamente al receptor plaquetario de integrina αIIbβ3 (glucoproteína IIb/IIIa). La trombastenia de Glanzmann se clasifica como tipo I cuando se expresa menos del 5 % de la glucoproteína αIIbβ3 y como tipo II, cuando es mayor al 5 %. Presentación del caso Se describe el manejo perioperatorio de una paciente de 13 años de edad con trombastenia de Glanzmann, sometida a etmoidectomía anterior bilateral endoscópica. El manejo se centró en la transfusión profiláctica de plaquetas y ácido tranexámico, así como en la evaluación de la hemostasia con tromboelastografía. No hubo complicaciones hemorrágicas durante y después del procedimiento. Conclusiones Los pacientes pediátricos con trombastenia de Glanzmann tienen alto riesgo de hemorragia perioperatoria. La transfusión de plaquetas es la mejor alternativa profiláctica y terapéutica; sin embargo, incluso en ausencia de anticuerpos antiplaquetarios, puede no ser efectiva y debe evaluarse mediante pruebas viscoelásticas durante los procedimientos quirúrgicos para mejorar la seguridad del paciente.
Subject(s)
Humans , Female , Adolescent , Thrombasthenia , Factor VIIa , Thrombelastography , Platelet Transfusion , Factor VII Deficiency , Genetic Diseases, InbornABSTRACT
RESUMEN Introducción: la hemofilia A y B severa son condiciones que predisponen al sangrado espontáneo. Una de las complicaciones de la terapia con concentrados de factores de coagulación es el desarrollo de anticuerpos o inhibidores contra los factores VIII o IX. El tratamiento en casos de inhibidores de título alto, para el control de la hemorragia, es la administración de agentes puente como el complejo protrombínico activado y Factor VII recombinante activado. La respuesta a cada uno de ellos no es predecible, en algunos casos puede ser necesario el uso de la terapia secuencial cuando esta estrategia falla. Objetivo: reportar cinco casos de hemofilia A severa e inhibidores de título alto con sangrado severo, sin respuesta clínica con monoterapia y que recibieron terapia secuencial. Métodos: estudio multicéntrico, descriptivo, observacional. Las variables cualitativas se presentan con frecuencias absolutas y relativas, y las cuantitativas se resumen con medidas de tendencia central. Resultados: cuatro pacientes evaluados que aportaron cinco eventos, la mediana de edad 20 años; mediana de días de monoterapia 10; 8,6 días de terapia secuencial, tiempo a resolver el sangrado cuatro días. Ausencia de complicaciones trombóticas. Conclusiones: la terapia secuencial es una opción para aquellos pacientes que no responden a la monoterapia y requieren control hemostático. En los cinco casos reportados, la terapia secuencial logró controlar el sangrado sin complicaciones.
SUMMARY Introduction and objectives: Patients diagnosed with severe hemophilia are at risk of developing inhibitors of low or high title, being the treatment of choice for this latter group of patients the immune tolerance therapy (ITI). In cases where the immune tolerance fails or presents bleeding events, we can use activated prothrombin complex (APCC) or Recombinant activated factor VII (rFVIIa); however, patients may fail to these agents as monotherapy. The aim of this paper is to report five cases of severe hemophilia and high titer inhibitors with mayor bleeding, which fail to respond to monotherapy and required sequential therapy. Methods: Case report study, qualitative variables are presented as absolute and relative frequencies and quantitative are summarized with measures of central tendency. Results: Five patients with median age 20 years; monotherapy treatment with median 10 days; 8.6 days of sequential therapy, time to control the bleeding: 4 days. There were no thrombotic complications. Conclusions: Sequential therapy is an option for patients who do not respond to monotherapy and requires hemostatic control. In all the cases of this report, the patients were responsive with bleeding control.
Subject(s)
Humans , Adult , Hemophilia B , Hemophilia A , TherapeuticsABSTRACT
BACKGROUND: Severe or massive postpartum hemorrhage (PPH) has remained a leading cause of maternal mortality for decades across the world and it results in critical obstetric complications. Recombinant activated factor VII (rFVIIa) has emerged as a gold standard adjunctive hemostatic agent for the treatment of life-threatening PPH refractory to conventional therapies although it remains off-licensed for use in PPH. We studied the effects of rFVIIa on coagulopathy, transfusion volume, prognosis, severity change in Korean PPH patients. METHODS: A retrospective review of medical records between December 2008 and March 2011 indicating use of rFVIIa in severe PPH was performed. We compared age, rFVIIa treatment, transfusion volume, and Sequential Organ Failure Assessment (SOFA) score at the time of arrival in the emergency department and after 24 hours for patients whose SOFA score was 8 points or higher. RESULTS: Fifteen women with SOFA score of 8 and above participated in this study and eight received rFVIIa administration whereas seven did not. Patients' mean age was 31.7 ± 7.5 years. There was no statistically significant difference in initial and post-24 hours SOFA scores between patients administered rFVIIa or not. The change in SOFA score between initial presentation and after 24 hours was significantly reduced after rFVIIa administration (P = 0.016). CONCLUSIONS: This analysis aimed to support that the administration of rFVIIa can reduce the severity of life-threatening PPH in patients. A rapid decision regarding the administration of rFVIIa is needed for a more favorable outcome in severe PPH patients for whom there is no effective standard treatment.
Subject(s)
Female , Humans , Emergency Service, Hospital , Factor VIIa , Maternal Death , Maternal Mortality , Medical Records , Organ Dysfunction Scores , Postpartum Hemorrhage , Postpartum Period , Prognosis , Recombinant Proteins , Retrospective StudiesABSTRACT
BACKGROUND: Severe or massive postpartum hemorrhage (PPH) has remained a leading cause of maternal mortality for decades across the world and it results in critical obstetric complications. Recombinant activated factor VII (rFVIIa) has emerged as a gold standard adjunctive hemostatic agent for the treatment of life-threatening PPH refractory to conventional therapies although it remains off-licensed for use in PPH. We studied the effects of rFVIIa on coagulopathy, transfusion volume, prognosis, severity change in Korean PPH patients. METHODS: A retrospective review of medical records between December 2008 and March 2011 indicating use of rFVIIa in severe PPH was performed. We compared age, rFVIIa treatment, transfusion volume, and Sequential Organ Failure Assessment (SOFA) score at the time of arrival in the emergency department and after 24 hours for patients whose SOFA score was 8 points or higher. RESULTS: Fifteen women with SOFA score of 8 and above participated in this study and eight received rFVIIa administration whereas seven did not. Patients' mean age was 31.7 ± 7.5 years. There was no statistically significant difference in initial and post-24 hours SOFA scores between patients administered rFVIIa or not. The change in SOFA score between initial presentation and after 24 hours was significantly reduced after rFVIIa administration (P = 0.016). CONCLUSIONS: This analysis aimed to support that the administration of rFVIIa can reduce the severity of life-threatening PPH in patients. A rapid decision regarding the administration of rFVIIa is needed for a more favorable outcome in severe PPH patients for whom there is no effective standard treatment.
Subject(s)
Female , Humans , Emergency Service, Hospital , Factor VIIa , Maternal Death , Maternal Mortality , Medical Records , Organ Dysfunction Scores , Postpartum Hemorrhage , Postpartum Period , Prognosis , Recombinant Proteins , Retrospective StudiesABSTRACT
Diffuse alveolar hemorrhage (DAH) is a life-threatening pulmonary complication in patients with hematologic malignancies or autoimmune disorders. The current treatment options, which include corticosteroids, transfusions, extracorporeal membrane oxygenation (ECMO), and immunosuppressants, have been limited and largely unsuccessful. Recombinant activated factor VII (rFVIIa) has been successfully administered, either systemically or bronchoscopically, to adults for the treatment of DAH, but there are few data on its use in pediatric patients. The current literature in the PubMed database was reviewed to evaluate the efficacy and risk of rFVIIa treatment for DAH in pediatric patients. This review discusses the diagnosis and treatment of DAH, as well as a new treatment paradigm that includes rFVIIa. Additionally, the risks and benefits of off-label use of rFVIIa in pediatric patients are discussed.
Subject(s)
Adult , Child , Humans , Adrenal Cortex Hormones , Diagnosis , Extracorporeal Membrane Oxygenation , Factor VIIa , Hematologic Neoplasms , Hemorrhage , Immunosuppressive Agents , Off-Label Use , Risk AssessmentABSTRACT
Diffuse alveolar hemorrhage (DAH) is a life-threatening pulmonary complication in patients with hematologic malignancies or autoimmune disorders. The current treatment options, which include corticosteroids, transfusions, extracorporeal membrane oxygenation (ECMO), and immunosuppressants, have been limited and largely unsuccessful. Recombinant activated factor VII (rFVIIa) has been successfully administered, either systemically or bronchoscopically, to adults for the treatment of DAH, but there are few data on its use in pediatric patients. The current literature in the PubMed database was reviewed to evaluate the efficacy and risk of rFVIIa treatment for DAH in pediatric patients. This review discusses the diagnosis and treatment of DAH, as well as a new treatment paradigm that includes rFVIIa. Additionally, the risks and benefits of off-label use of rFVIIa in pediatric patients are discussed.
Subject(s)
Adult , Child , Humans , Adrenal Cortex Hormones , Diagnosis , Extracorporeal Membrane Oxygenation , Factor VIIa , Hematologic Neoplasms , Hemorrhage , Immunosuppressive Agents , Off-Label Use , Risk AssessmentABSTRACT
La transfusión masiva es considerada como pieza fundamental en el manejo agudo de la hemorragia masiva. Si bien los protocolos existentes no estandarizan su uso, sí recomiendan su aplicación oportuna y una dosificación ajustada al tipo de hemoderivado, una relación proporcionada entre hemocomponentes y coadyuvancia justa de medicamentos, así como técnicas que promuevan el control de la hemorragia y prevengan síndromes desencadenantes de muerte. Esta revisión no sistemática tiene como objetivo resumir los conceptos actuales sobre el manejo agudo de la hemorragia masiva relacionada con trauma desde una perspectiva no quirúrgica.La búsqueda de artículos se limitó a los últimos 10 años, y se realizó en bases de datos primarias y secundarias; todo ello terminó en una técnica de bola de nieve.
Massive transfusion is considered a key component in the acute management of massive hemorrhage. While the existing protocols do not standardize its use, they do recommend its timely administration and a dose adjusted to the type of blood product, a proportionate ratio between hemocomponents and appropriate adjuvant drug support, in addition to techniques that promote bleeding control and prevent syndromes that could trigger a fatal outcome. This non-systematic review is intended to summarize the current concepts on the acute management of massive bleeding in trauma, from a non-surgical perspective. The search was limited to the articles of the last 10 years and included primary and secondary data basis, leading to a snowball technique.
Subject(s)
HumansABSTRACT
JUSTIFICATIVA E OBJETIVOS: Trombastenia de Glanzmann (TG) é uma doença autossômica recessivamente hereditária das plaquetas. Não há nenhum tratamento específico. A transfusão de plaquetas é atualmente o tratamento padrão quando o sangramento não responde a medidas locais e/ou a medicamentos antifibrinolíticos, podendo, entretanto, resultar em aloimunização. O fator VII recombinante ativado (rFVIIa) pode ser usado para evitar a transfusão recorrente de plaquetas. RELATO DE CASO: Apresentamos um tratamento precoce com dose baixa de rFVIIa associada à transfusão de plaquetas em um caso pediátrico (cinco anos de idade), com diagnóstico de TG e apresentando sangramento prolongado durante adenoidectomia eletiva. Uma dose total de 1.200 mg (60 µg.kg-1) de rFVIIa obteve sucesso em estancar o sangramento, o que pode ser aceito como uma dose baixa. CONCLUSÕES: Relatos de casos podem encorajar o uso de tratamento precoce com baixas doses de rFVIIa em hemorragias graves que não estacam a despeito da transfusão de plaquetas e na prevenção de sangramento em procedimentos cirúrgicos em pacientes com TG. Estudos adicionais são necessários para definir a dose mínima eficaz. Portanto, as tentativas para determinar a dose eficaz mais baixa desse composto devem ser incentivadas consideando o resultado deste caso em face de restrições financeiras no sistema de saúde.
BACKGROUND AND OBJECTIVE: Glanzmann's thrombasthenia (GT) is an autosomal recessively inherited platelet disorder. There is not any specific treatment. Platelet transfusion is currently the standard treatment when bleeding does not respond to local measures and/or antifibrinolytic treatment, although it may result in alloimmunization. Recombinant activated factor VII (rFVIIa) might be used to avoid recurrent platelet transfusion. CASE REPORT: We present early treatment with low-dose rFVIIa additional to platelet transfusion in a 5-year-old pediatric case with diagnosis of GT who developed prolonged bleeding under an elective adenoidectomy surgery. A total dose of 1,200 µg (60 µg.kg-1) rFVIIa could successfully stop bleeding, what can be accepted as low dose usage. CONCLUSIONS: Such case reports may encourage the use of early treatment with low doses of rFVIIa in severe bleeds that did not stop despite of platelet transfusion, as well as in preventing bleeding in surgical procedures in patients with GT. Actually, additional studies are needed to define the minimal effective dose and attempts to determine the lowest effective dose may be encouraged by the result of this case, considering financial restrictions in the health care system.
JUSTIFICATIVA Y OBJETIVOS: La Trombastenia de Glanzmann (TG) es una enfermedad autosómica recesivamente hereditaria de las plaquetas. No hay ningún tratamiento específico. La transfusión de plaquetas es hoy por hoy, el tratamiento estándar cuando el sangramiento no responde a medidas locales y/o a medicamentos antifibrinolíticos, pudiendo sin embargo, resultar en una aloinmunización. El factor VII recombinante activado (rFVIIa) puede ser usado para evitar la transfusión recurrente de plaquetas. RELATO DE CASO: Presentamos aquí un rápido tratamiento con una dosis baja de rFVIIa asociada a la transfusión de plaquetas en un caso pediátrico (5 años de edad), con diagnóstico de TG y presentando un sangramiento prolongado durante la adenoidectomía electiva. Una dosis total de 1.200 mg (60 µg.kg-1) de rFVIIa tuvo éxito al estancar el sangramiento, lo que puede aceptarse como una dosis baja. CONCLUSIONES: Relatos de casos pueden estimular el uso de tratamiento rápido con bajas dosis de rFVIIa en las hemorragias graves que no estancan, pese a la transfusión de plaquetas y a la prevención de sangramiento en los procedimientos quirúrgicos en pacientes con TG. Sin embargo, estudios adicionales se hacen necesarios para definir la dosis mínima eficaz. Por tanto, los intentos para determinar la dosis eficaz más baja de un compuesto tan caro deben ser incentivados debido al resultado de este caso cuando existan restricciones financieras en el sistema de Sanidad.
Subject(s)
Child, Preschool , Humans , Male , Adenoidectomy , Factor VIIa/therapeutic use , Platelet Transfusion , Postoperative Hemorrhage/etiology , Postoperative Hemorrhage/therapy , Thrombasthenia/complications , Combined Modality Therapy , Postoperative Care , Recombinant Proteins/therapeutic useABSTRACT
BACKGROUND: Recent studies and case reports have shown that recombinant factor VIIa (rFVIIa) treatment is effective for reversing coagulopathy and reducing blood transfusion requirements in trauma patients with life-threatening hemorrhage. The purpose of this study is to evaluate the effect of rFVIIa treatment on clinical outcomes and cost effectiveness in trauma patients. METHODS: Between January 2007 and December 2010, we reviewed the medical records of patients who were treated with rFVIIa (N=18) or without rFVIIa (N=36) for life-threatening hemorrhage due to multiple traumas at the Emergency Department of Pusan National University Hospital in Busan, Korea. We reviewed patient demographics, baseline characteristics, initial vital signs, laboratory test results, and number of units transfused, and then analyzed clinical outcomes and 24-hr and 30-day mortality rates. Thromboembolic events were monitored in all patients. Transfusion costs and hospital stay costs were also calculated. RESULTS: In the rFVIIa-treated group, laboratory test results and clinical outcomes improved, and the 24-hr mortality rate decreased compared to that in the untreated group; however, 30-day mortality rate did not differ between the groups. Thromboembolic events did not occur in both groups. Transfusion and hospital stay costs in the rFVIIa-treated group were cost effective; however, total treatment costs, including the cost of rFVIIa, were not cost effective. CONCLUSIONS: In our study, rFVIIa treatment was shown to be helpful as a supplementary drug to improve clinical outcomes and reduce the 24-hr mortality rate, transfusion and hospital stay costs, and transfusion requirements in trauma patients with life-threatening hemorrhage.
Subject(s)
Adult , Aged , Aged, 80 and over , Humans , Middle Aged , Factor VIIa/therapeutic use , Hemoglobins/analysis , Hemorrhage/complications , Multiple Trauma/complications , Partial Thromboplastin Time , Platelet Count , Prothrombin Time , Recombinant Proteins/therapeutic use , Retrospective Studies , Treatment OutcomeABSTRACT
Actualmente se acepta de forma categórica que el evento iniciador principal de la coagulación sanguínea es la exposición del factor tisular (FT), lo cual da lugar a la formación del complejo factor VIIa/FT que activa a los factores IX y X en la superficie de las células que expresan el FT y, por último, la producción de trombina. A continuación se revisarán los aspectos relacionados con la nueva teoría celular que trata de explicar de una forma más fisiológica todos los eventos que ocurren durante la coagulación y al final se tocarán algunos aspectos relacionados con los trastornos de la coagulación en el paciente traumatizado.
It is now accepted categorically that the main initiating event of blood coagulation is exposure of tissue factor (TF), which leads to the formation of the complex factor VIIa / TF that activates factors IX and X on the surface of cells expressing the FT, and finally the production of thrombin. Below is a detailed review of all aspects related to the new cell theory tries to explain in a more physiological all events that occur during the coagulation process and at the end some aspects of coagulation disorders in the trauma patient will be displayed.
Subject(s)
Humans , Hemostasis , Thromboplastin , Thrombin , Blood Coagulation/physiology , Multiple TraumaABSTRACT
Little is known about the prophylactic use of recombinant factor VIIa (rFVIIa) in patients undergoing surgery for a bleeding aorta employing cardiopulmonary bypass. We report the successful use of rFVIIa in a patient undergoing hypothermic circulatory arrest and prolonged cardiopulmonary bypass for repair of a DeBakey type III aortic dissection.
Subject(s)
Humans , Aorta , Cardiopulmonary Bypass , Factor VIIa , Hemorrhage , Recombinant ProteinsABSTRACT
La eficacia del tratamiento con factor VII activado recombinante (FVIIar) durante episodios hemorrágicos en pacientes hemofílicos con inhibidores y el conocimiento de su mecanismo de acción, determiná que en los últimos años se ampliara rápidamente su uso en pacientes con hemorragia de diversas causas no controladas con la terapéutica habitual; entre otras, defectos congénitos de la coagulación, trastornos plaquetarios, hepatopatías, cirugía, hemorragia intracraneal, sangramientos digestivos. Aunque un grupo importante de estas comunicaciones se han realizado en forma de casos reportados y serie de casos, se considera que los resultados obtenidos son importantes y que la administración de FVIIar es una alternativa en pacientes con hemorragia grave no controlada. A pesar de su potente acción procoagulante, el riesgo de complicaciones tromboembólicas es bajo y esté relacionado en un grupo importante de pacientes con la presencia de otros factores protrombóticos. En la actualidad se considera que el FVIIar esta indicado en aquellos pacientes con hemorragia masiva que no responden a la terapia con componentes sanguíneos ni a medidas quirúrgicas apropiadas
Effectiveness of the treatment with recombinant activated factor VII (raVII) during the hemorrhagic episodes in hemophilic patients using inhibitions and the knowledge of its action mechanism determined that in pas years its use will be expanded in patients with hemorrhage from non-controlled diverse causes using the usual therapeutics among other, congenital coagulation defects, platelet disorders, liver diseases, surgery, intracranial hemorrhage, digestive bleedings. Although a significant group of these communications have been carried out in reported cases and in cases series, it is considered that the results obtained are important and that the administration of raVII is an alternative in patients presenting with non-controlled severe hemorrhage. Despite its potent pro-coagulant action, thromboembolism complications risk is low and it is related to a significant group of patients with other prothrombotic factors. Nowadays, it is considered that raVII is prescribed in those patients with massive hemorrhage without response either to therapy using blood components or appropriate surgical measures
Subject(s)
Humans , Factor VII/therapeutic use , Hemophilia A/complications , Hemorrhagic Disorders/drug therapy , Case ReportsABSTRACT
La deficiencia del factor VII es una enfermedad hemorrágica rara, causada por la disminución o ausencia de este factor de la coagulación; menos de 200 casos se han reportado desde que se describió por primera vez en 1951. Es un trastorno autonómico recesivo que puede afectar a varios miembros de una familia. Su prevalencia es de 1:500.000 (0,5% de todos los trastornos hereditarios de la coagulación) y su distribución es igual entre los sexos. El defecto está localizado en el cromosoma 13q34. Sólo los individuos homocigotos o heterocigotos compuestos, es decir, que son portadores de dos mutaciones diferentes, presentan manifestaciones hemorrágicas. Los heterocigotos son asintomáticos. El déficit puede ser cualitativo o cuantitativo. La forma de presentación clínica es variable y la seriedad de las hemorragias no guarda relación directa con los niveles de factor VII o su actividad. El cuadro clínico puede ser muy grave y se puede presentar hemorragia intracerebral temprana, hemartrosis o manifestaciones moderadas, dadas por sangrado mucocutáneo o hemorragia tras una intervención quirúrgica; algunos casos pueden cursar asintomáticos, a pesar de valores muy bajos de factor VII. El diagnóstico se hace mediante pruebas de coagulación, al encontrar un tiempo de protrombina prolongado con un tiempo parcial de tromboplastina normal y con la posterior cuantificación de factor VII disminuido (valores normales de 70 a 130%).
Factor VII deficiency is a rare hemorrhagic disease caused by the decrease or absence of this coagulation factor; no more than 200 cases have been reported since it was first discovered in 1951. It is an autosomal recessive disorder, which may affect several members of a family. Its prevalence is 1:500,000 (0.5% of all hereditary disorders of coagulation) and its distribution is the same in both genders. The defect is located on chromosome 13q34. Only homozygous or compound heterozygous individuals have different hemorrhagic manifestations. The heterozygotes are asymptomatic. The deficit may be qualitative or quantitative. The clinical manifestations are variable and the severity of bleeding is not directly related to factor VII titers or its activity. The clinical picture may be very severe, patients could present with an early intracerebral hemorrhage, hemarthrosis or moderate findings, given by mucocutaneous bleeding or bleeding after surgery, moreover in some cases it may be asymptomatic despite very low values of factor VII. The diagnosis is made by coagulation tests to find a prolonged prothrombin time with a normal PTT and the subsequent quantification of factor VII decreased (VN 70-130%).
Subject(s)
Hematologic Diseases , Bone Diseases , Kidney DiseasesABSTRACT
Antecedentes. En el enfermo grave, la hemorragia crítica aguda refractaria al manejo convencional es una complicación frecuente de etiología multifactorial con alta morbilidad y mortalidad. El factor VII recombinante activado (FVIIra) es una nueva alternativa terapéutica en estos casos. Objetivo. Presentar el análisis descriptivo en pacientes no hemofílicos con hemorragia grave tratados con FVIIra. Material y métodos. Diez pacientes no hemofílicos con hemorragia grave, cinco hombres y cinco mujeres, edad entre 18 y 74 años, tratados con FVIIra. Se aplicó una prueba de t para el análisis estadístico. Se consideró una p < 0.001 como significativa. Resultados. Después de la administración del FVIIra se controló la hemorragia y disminuyó el uso de hemoderivados en los diez pacientes tratados (p < 0.001). Los tiempos de coagulación, concentraciones de fibrinógeno, cuenta plaquetaria y parámetros de perfusión tisular mejoraron significativamente después de la aplicación del FVIIra (p < 0.001). Conclusiones. El FVIIra es una alternativa terapéutica útil en enfermos graves que cursan con hemorragia crítica aguda no controlada con el manejo convencional.
BACKGROUND: Severe hemorrhage is a frequent complication with multiple etiologies and high morbi-mortality observed among critically ill patients. Recombinant Factor VIla (rFVlla) constitutes a new therapeutic alternative. OBJECTIVE: Analyze the evolution in a non-hemophiliac patient group with severe hemorrhage treated with rFVlla. MATERIAL AND METHODS: Ten non-hemophiliac patients with severe hemorrhage, five men and five women between 18 and 74 years, were included and treated with rFVIIa. We used a t test for statistic analyses. Significance was set at p < 0.001. RESULTS: Among patients treated with rFVlla, hemorrhage was controlled and the use of blood products was significantly diminished (p < 0.001). Coagulation tests, fibrinogen levels, platelet count and perfusion parameters increased significantly (p < 0.001). CONCLUSIONS: rFVIIa is a therapeutic alternative for the treatment of severe hemorrhage not controlled by conventional management.