RESUMEN

OBJECTIVE: To determine whether peripheral blood parameters have any predictive value for all-frequency Sudden Sensorineural Hearing Loss (SSNHL). METHODS: We chose 78 individuals with all-frequency SSNHL who had been admitted to our department. They were divided into two groups: the effective group and the ineffective group. In patients with all-frequency SSNHL, the prognostic variables, including peripheral blood tests and clinical traits, were examined by a logistic regression analysis. In addition, the predictive value was carried out. RESULTS: The effective rate of all-frequency SSNHL was 61.5%. Pre-treatment hearing level and the proportion of patients with diabetes were both significantly lower in the effective group than in the ineffective group (p = 0.024 and 0.000, respectively). The levels of fibrinogen and C-reactive protein were also significantly different between the two groups (p = 0.001 and 0.025, respectively). Pre-treatment hearing level and fibrinogen level both significantly impacted the prognosis of all-frequency SSNHL (p = 0.032 and 0.002, respectively), according to a logistic regression analysis. Furthermore, the prognosis was significantly predicted by both fibrinogen level and pre-treatment hearing level (p = 0.001 and 0.0002, respectively). The receiver operating characteristic curve showed that the fibrinogen level had a sensitivity of 85.4% and a specificity of 60.0% for predicting the prognosis of all-frequency SSNHL. CONCLUSION: For the prognosis of all-frequency SSNHL, the fibrinogen level can be regarded as a useful predictor. The level of C-reactive protein, however, does not have a significant prognostic effect on predicting all-frequency SSNHL. Therefore, more attention should be devoted to the level of fibrinogen in the acute period of all-frequency SSNHL.

Asunto(s)

Pérdida Auditiva Sensorineural , Pérdida Auditiva Súbita , Humanos , Pronóstico , Proteína C-Reactiva/análisis , Estudios Retrospectivos , Pérdida Auditiva Sensorineural/tratamiento farmacológico , Pérdida Auditiva Súbita/tratamiento farmacológico , Fibrinógeno/análisis , Fibrinógeno/uso terapéutico

RESUMEN

INTRODUCTION: The objectives of this study are to experimentally evaluate the haemostatic effects of two organic substances, a membrane of chitosan and a collagen sponge coated with thrombin and human fibrinogen (TachoSil®), in sealing 7-0 needle stitches holes on the femoral arteries of rats as well as to evaluate local histological reactions. METHODS: Twenty-four rats were included, and four holes were made in each common femoral artery. In the control group, haemostasis was achieved only by compression with gauze sponge; and in the two other groups, haemostasis was achieved with application of one of these two substances. RESULTS: Membrane of chitosan and TachoSil® showed a power to reduce the time to achieve haemostasis compared with the control group (P=0.001), and the haemostatic effects of these two substances were comparable. There was lower blood loss in the groups where these two substances were used when compared with the control group, but no difference was found comparing the two substances. CONCLUSION: The use of these sealants did not promote more adhesion or local histological reactions when compared to the control group. Since chitosan is easy to find in nature, has a positive effect to promote haemostasis, and did not bring considerable local reactions, it might be used as a sealant in cardiovascular surgery.

Asunto(s)

Quitosano , Hemostáticos , Animales , Quitosano/farmacología , Colágeno/farmacología , Colágeno/uso terapéutico , Combinación de Medicamentos , Fibrinógeno/farmacología , Fibrinógeno/uso terapéutico , Hemostasis Quirúrgica , Hemostáticos/farmacología , Hemostáticos/uso terapéutico , Humanos , Ratas , Trombina/farmacología

RESUMEN

MANDAT: À la demande du fabricant Octapharma Canada Inc., l'Institut national d'excellence en santé et en services sociaux (INESSS) a procédé à l'évaluation du produit FibrygaMC, un concentré de fibrinogène humain. Ce produit est indiqué « pour le traitement d'épisodes de saignement aigus et la prophylaxie périopératoire chez les adultes et les enfants atteints d'afibrinogénémie ou d'hypofibrinogénémie congénitale ¼ ainsi que « comme traitement complémentaire durant la prise en charge de saignements sévères non contrôlés survenant au cours d'interventions chirurgicales chez les patients atteints d'un déficit acquis en fibrinogène ¼. La présente évaluation porte sur l'indication ciblant le déficit acquis en fibrinogène. DÉMARCHE D'ÉVALUATION: Une revue des données issues de la littérature et de celles fournies par le fabricant a été réalisée afin d'évaluer l'efficacité, l'innocuité et l'efficience du concentré de fibrinogène humain FibrygaMC. Des données contextuelles et expérientielles issues de la consultation d'experts sont également présentées. DIMENSIONS SOCIOCULTURELLE ET POPULATIONNELLE: Le déficit acquis en fibrinogène, aussi appelé hypofibrinogénémie acquise, est généralement causé par l'utilisation de facteurs de coagulation à la suite de saignements importants. L'hypofibrinogénémie acquise peut survenir de façon imprévisible chez les adultes et les enfants au cours d'interventions chirurgicales, de traumatismes importants, durant la période post-partum ou dans le cas de certaines maladies. Les cryoprécipités sont présentement utilisés pour compenser le déficit en fibrinogène. Ceux-ci sont produits par Héma-Québec en congelant et en décongelant du plasma et contiennent principalement du fibrinogène ainsi que d'autres facteurs de coagulation. Les besoins à combler pour le traitement de l'hypofibrinogénémie acquise en contexte chirurgical sont limités. Des options thérapeutiques permettant une administration plus rapide et sans aucun risque de transmission d'agents infectieux pourraient toutefois représenter un certain avantage par rapport à la situation actuelle. DÉLIBÉRATION SUR LA VALEUR THÉRAPEUTIQUE: Les membres du Comité scientifique de l'évaluation des médicaments aux fins d'inscription (CSEMI) sont unanimement d'avis que la valeur thérapeutique du concentré de fibrinogène FibrygaMC est reconnue comme traitement complémentaire durant la prise en charge de saignements sévères non contrôlés survenant au cours d'interventions chirurgicales chez les patients atteints d'un déficit acquis en fibrinogène. Motifs de la position unanime: Les membres sont d'avis que les résultats de l'étude canadienne FIBRES sont suffisants pour reconnaitre la non-infériorité du concentré de fibrinogène comparativement aux cryoprécipités dans la prise en charge des saignements liés à l'hypofibrinogénémie acquise en contexte de chirurgie cardiaque avec circulation extracorporelle. Les résultats de l'étude FORMA-05 appuient l'utilisation du concentré de fibrinogène dans des contextes chirurgicaux autres que la chirurgie cardiaque avec circulation extracorporelle. Les membres reconnaissent que le concentré de fibrinogène et les cryoprécipités partagent un profil d'effets indésirables similaire. Ils estiment par ailleurs que les risques de réactions transfusionnelles et de transmission d'agents infectieux inconnus associés aux cryoprécipités sont très faibles. Le concentré de fibrinogène représente une option thérapeutique de remplacement par rapport aux cryoprécipités, qui comblerait en partie le besoin de santé jugé faible pour le contexte de prise en charge de l'hypofibrinogénémie acquise en contexte chirurgical. Selon les membres du comité, les conclusions sur la valeur thérapeutique du concentré de fibrinogène s'appliquent aux conditions médicales où l'hypofibrinogénémie acquise est clairement démontrée. Délibération sur l'ensemble des critères: Les membres du Comité scientifique de l'évaluation des médicaments aux fins d'inscription (CSEMI) sont unanimement d'avis d'ajouter le concentré de fibrinogène FibrygaMC à la Liste des produits du système du sang du Québec comme traitement complémentaire durant la prise en charge de saignements sévères non contrôlés survenant au cours d'interventions chirurgicales chez les patients atteints d'un déficit acquis en fibrinogène. Motifs de la position unanime: Les membres reconnaissent une valeur thérapeutique non inférieure au concentré de fibrinogène par rapport aux cryoprécipités pour la prise en charge des saignements périopératoires chez les patients atteints d'hypofibrinogénémie acquise. Au prix soumis par le fabricant, le traitement par FibrygaMC est une option thérapeutique plus efficiente que les cryoprécipités actuellement distribués au Québec. Les membres soulignent que l'utilisation des cryoprécipités est associée à des pertes. Ils rappellent que le sang est une ressource précieuse et limitée dont l'utilisation doit être faite judicieusement par le système de soins. Toute réduction des pertes de produits sanguins devrait donc être valorisée. La distribution de FibrygaMC pour la prise en charge de l'hypofibrinogénémie acquise engendrerait une réduction des coûts estimée à 7,4 M$ sur le budget des établissements de santé au cours des trois prochaines années. Les membres sont d'avis que le concentré de fibrinogène a le potentiel de réduire les délais d'administration en contexte chirurgical si sa préparation est faite au bloc opératoire plutôt qu'à la banque de sang. Ils ajoutent toutefois que les conséquences d'une administration plus rapide du concentré de fibrinogène n'ont pas été investiguées. Recommandation de l'INESSS sur FibrygaMC: À la lumière des informations disponibles, l'INESSS recommande d'ajouter le concentré de fibrinogène FibrygaMC à la Liste des produits du système du sang du Québec comme traitement complémentaire durant la prise en charge de saignements sévères non contrôlés survenant au cours d'interventions chirurgicales chez les patients atteints d'un déficit acquis en fibrinogène.

---

MANDATE: At the request of the manufacturer, Octapharma Canada Inc., the Institut national d'excellence en santé et en services sociaux (INESSS) evaluated Fibryga™, a human fibrinogen concentrate. This product is indicated "for the treatment of acute bleeding episodes and perioperative prophylaxis in adult and pediatric patients with congenital afibrinogenemia and hypofibrinogenemia" and "as a complementary therapy during the management of uncontrolled severe bleeding in patients with acquired fibrinogen deficiency in the course of surgical interventions". The present evaluation concerns the indication involving acquired fibrinogen deficiency. EVALUATION PROCESS: Data from the scientific literature and those provided by the manufacturer were reviewed to document the efficacy, safety and cost-effectiveness of the human fibrinogen concentrate Fibryga™. Contextual and experiential data from the expert consultations are also presented. Lastly, INESSS performed a cost-effectiveness and budget impact analysis. SOCIOCULTURAL AND POPULATIONAL DIMENSIONS Acquired fibrinogen deficiency, also known as acquired hypofibrinogenemia, is usually caused by the consumptionof coagulation factors following major bleeding. Acquired hypofibrinogenemia can occur unpredictably in adults and children during surgical interventions, major trauma, during the postpartum period, and in certain diseases. Cryoprecipitate is currently used to compensate for fibrinogen deficiency. It is produced by Héma-Québec by freezing and thawing plasma and contains mainly fibrinogen and other coagulation factors. The need regarding the treatment of acquired hypofibrinogenemia in the surgical context is limited. However, therapeutic options that allow faster fibrinogen administration without the risk of transmitting infectious agents could offer a certain advantage over the current situation. DELIBERATION REGARDING THERAPEUTIC VALUE: The members of the Comité scientifique de l'évaluation des médicaments aux fins d'inscription (CSEMI) are of the unanimously opinion that the therapeutic value of the fibrinogen concentrate Fibryga™ is recognized when used as complementary therapy during the management of severe uncontrolled bleeding during surgical interventions in patients with acquired fibrinogen deficiency. Reasons for the unanimous position. The members feel that the results of the Canadian study FIBRES are sufficient to recognize the noninferiority of fibrinogen concentrate to cryoprecipitate in the management of bleeding related to acquired hypofibrinogenemia in the context of cardiac surgery with extracorporeal circulation. The results of the FORMA-05 study support the use of fibrinogen concentrate during surgery other than cardiac surgery with extracorporeal circulation. The members recognize that fibrinogen concentrate and cryoprecipitate have a similar adverse effect profile. They also feel that the risks of transfusion related reactions and transmission of unknown infectious agents associated with cryoprecipitate are very low. Fibrinogen concentrate represents an alternative therapeutic option to cryoprecipitate that would address, in part, the health need associated with the management of acquired hypofibrinogenemia in a surgical context, which is considered small. According to the committee members, the conclusions regarding the therapeutic value of fibrinogen concentrate also apply to the medical conditions in which ACQUIRED HYPOFIBRINOGENEMIA IS CLEARLY DEMONSTRATED. DELIBERATION regarding all the criteria: The members of the Comité scientifique de l'évaluation des médicaments aux fins d'inscription (CSEMI) are of the unanimously opinion that the fibrinogen concentrate Fibryga™ should be added to the Liste des produits du système du sang du Québec as complementary therapy during the management of severe uncontrolled bleeding during surgical interventions in patients with acquired fibrinogen deficiency. Reasons for the unanimous position: The members recognize the noninferior therapeutic value of fibrinogen concentrate relative to cryoprecipitate for the management of perioperative bleeding in patients with acquired hypofibrinogenemia. At the price submitted by the manufacturer, Fibryga™ is a more cost-effective treatment option than the cryoprecipitate currently distributed in Québec. The members note that the use of cryoprecipitate is associated with wastage. They stated that blood is a precious and limited resource that should be used judiciously by the healthcare system. Any reduction in blood product wastage should therefore be valued. Distributing Fibryga™ for the management of acquired hypofibrinogenemia would result in an estimated $7.4 million in cost savings in the health-care facility budget over the next 3 years. The members believe that fibrinogen concentrate has the potential to reduce administration times in surgical context if it is prepared in the operating room instead of the blood bank. However, they add that the impact of faster administration of fibrinogen concentrate has not been investigated. INESSS'S RECOMMENDATION CONCERNING FIBRYGA™: In light of the available data, INESSS recommends that the fibrinogen concentrate Fibryga™ be added to the Liste des produits du système du sang du Québec as complementary therapy during the management of severe uncontrolled bleeding during surgical interventions in patients with acquired fibrinogen deficiency.

Asunto(s)

Humanos , Fibrinógeno/uso terapéutico , Afibrinogenemia/tratamiento farmacológico , Evaluación en Salud/economía , Eficacia

RESUMEN

Resumen Introducción: Un adecuado manejo del sangrado debe incluir la correcta valoración y eventual reposición de fibrinógeno. Las fuentes tradicionales de este elemento hemostático incluyen el plasma fresco congelado y los crioprecipitados. Los concentrados liofilizados de fibrinógeno humano (CFH) son una alternativa terapéutica novedosa en el mercado chileno. Objetivo: Este estudio describe el curso clínico de los primeros pacientes en nuestra institución requirentes de CFH, dentro de un algoritmo de reposición hemostática por metas. Materiales y Método: Serie de pacientes con hipofibrinogenemia secundaria a sangrado perioperatorio severo, en los que se utilizó CFH como método de reposición de fibrinógeno. Se utilizó tromboelastometría para definir dosis. Se registraron variables demográficas, operatorias, complicaciones y seguimiento hasta los 3 meses. Resultados: Se utilizaron CFH en 18 pacientes. La mediana de edad fue 40,7 (56,5-63) años y dos tercios de los pacientes fueron de sexo masculino. Fallecieron 5 pacientes de la serie. Todos los pacientes requirieron manejo posoperatorio en una unidad de cuidados intensivos. Ocho pacientes fueron sometidos a cirugía cardiaca. El uso de hemocomponentes y concentrados liofilizados fue heterogéneo, pero en todos los casos su uso fue determinado por tromboelastometría. Ningún paciente fue reintervenido a causa de sangrado posoperatorio. Conclusión: El uso de concentrados de fibrinógeno humano dentro de un algoritmo de manejo de sangrado guiado por tromboelastometría, es un recurso hemostático factible en la realidad nacional. El impacto clínico de esta intervención requiere una subsiguiente evaluación basada en la evidencia.

---

Introduction: An adequate bleeding management should include a proper assessment of fibrinogen values and consequent replacement. Traditional sources for this hemostatic element include fresh frozen plasma and cryoprecipitates. Lyophilized human fibrinogen concentrates are a novel therapeutic alternative for the chilean market. Aim: This study aims to describe the clinical course of the first patients in our institution receiving fibrinogen concentrates, included in a goal directed hemostatic management algorithm. Materials and Method: Case series of patients with hypofibrinogenemia secondary to severe perioperative bleeding, in which fibrinogen concentrate was used for fibrinogen replacement. Thromboelastometry was used to define dose regimens. Demographic and surgical variables, complications and follow-up up to 3 months were registered. Results: Fibrinogen concentrate was used in 18 patients. Median age was 40.7 (56.5-63) years, and two thirds of the patients were male. Five patients died. All of the cases required postoperative intensive care. Eight patients underwent cardiac surgery. There was a heterogenic use of blood derived products and lyophilized concentrates, but in all cases its use was guided by thromboelastometry. No patients needed a secondary exploration due to bleeding. Conclusion: The use of human fibrinogen concentrate included in a bleeding management algorithm is a feasible hemostatic resource in the chilean current situation. The clinical impact of this intervention requires further evidence-based evaluation.

Asunto(s)

Humanos , Masculino , Fibrinógeno/uso terapéutico , Afibrinogenemia/tratamiento farmacológico , Afibrinogenemia/sangre , Materiales Biocompatibles , Pérdida de Sangre Quirúrgica , Estimación de Kaplan-Meier

RESUMEN

BACKGROUND AND OBJECTIVE: The use of fibrinogen concentrate to treat or prevent major bleeding with regard to potential adverse reactions has not been free of controversy. Our objective was to perform a post-authorization safety study to describe the use of Clottafact® (LFB Biomedicaments) fibrinogen concentrate in real-life medical practice in Mexico. METHODS: This was a prospective, observational study that collected and evaluated information between January 2017 and June 2019 related to suspected serious adverse reactions (SUSARs) during and after Clottafact® infusion. RESULTS: Information from 40 subjects was analyzed; 43% were women (n = 17), mean age was 39.05 ± 26.8 years (range 0-91 years). The medical specialties included in this analysis were cardiac surgery - 52.5% of the cases, gynecology/obstetrics - 17.5%, general surgery and orthopedics - 12.5% each, and hematology and neurosurgery - 2.5%, respectively. Mean plasma fibrinogen levels before and after Clottafact® infusion were 2.58 g/L and 4.02 g/L; p = 0.001, respectively. The mean Clottafact® dose was 2.20 ± 0.77 g. One patient presented SUSARs (dry mouth and dysgeusia) with drug administration, which ceased after treatment discontinuation. CONCLUSIONS: In this real-life post-marketing study, the safety profile of Clottafact® was very similar to previous reports. Thus, Clottafact® shows a favorable safety profile in clinical practice.

Asunto(s)

Fibrinógeno/uso terapéutico , Hemorragia/tratamiento farmacológico , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Niño , Preescolar , Femenino , Fibrinógeno/efectos adversos , Hemostáticos , Humanos , Lactante , Recién Nacido , Masculino , México , Persona de Mediana Edad , Embarazo , Estudios Prospectivos , Adulto Joven

RESUMEN

INTRODUCTION: Thromboelastometry evaluates viscoelastic changes in the coagulation process. It offers a graphic representation of the formation of the coagulum, its stability and the presence of lysis. OBJECTIVE: This first case of transfusion management guided by thromboelastography in Mexico and we conducted a review of the literature. METHOD: A metasearch search was performed (PubMed, Scielo, Medigraphic) with the words thromboelastometry, coagulopathy, transfusion medicine and the most influential works were included. CONCLUSIONS: The rotational thromboelastometry is a diagnostic tool that graphs the functionality of the clot, for a directed and individualized management of the coagulopathy associated with bleeding.

---

INTRODUCCIÓN: La tromboelastometría evalúa los cambios viscoelásticos en el proceso de coagulación. Ofrece una representación gráfica de la formación del coágulo, su estabilidad y la presencia de lisis. OBJETIVO: Se notifica el primer caso de manejo transfusional guiado por tromboelastografía en México con revisión de la bibliografía. MÉTODO: Se realizó una búsqueda en metabuscadores (PubMed, Scielo, Medigraphic) con las palabras tromboelastometría, coagulopatía y medicina transfusional y se incluyeron los trabajos más influyentes. CONCLUSIONES: La tromboelastometría rotacional es una herramienta diagnóstica que grafica la funcionalidad del coágulo para un manejo dirigido e individualizado de la coagulopatía relacionada con ­hemorragia.

Asunto(s)

Transfusión de Componentes Sanguíneos/métodos , Choque/terapia , Tromboelastografía/métodos , Tiempo de Coagulación de la Sangre Total/métodos , Adolescente , Afibrinogenemia/tratamiento farmacológico , Afibrinogenemia/etiología , Plaquetas/fisiología , Traumatismos Craneocerebrales/complicaciones , Traumatismos Craneocerebrales/cirugía , Soluciones Cristaloides/administración & dosificación , Urgencias Médicas , Transfusión de Eritrocitos/métodos , Resultado Fatal , Femenino , Fibrinógeno/uso terapéutico , Humanos , México , Plasma , Choque/etiología , Heridas por Arma de Fuego/complicaciones , Heridas por Arma de Fuego/cirugía

RESUMEN

Decompressive craniectomy (DC) is a therapeutic alternative for reducing intracranial pressure after a middle cerebral artery stroke. If thrombolytic therapy is administered, craniectomy is usually postponed for at least 24 hours due to a risk of severe bleeding. We describe a case in which DC was performed on a 38-year-old man who received thrombolytic therapy for an ischemic stroke involving the middle cerebral artery. His neurological and hemodynamic status worsened during its administration, and DC was performed 6 hours after thrombolysis was performed. Fibrinolytic coagulopathy was successfully managed by monitoring fibrinogen levels and with the administration of cryoprecipitate and tranexamic acid.

Asunto(s)

Craniectomía Descompresiva/métodos , Infarto de la Arteria Cerebral Media/cirugía , Terapia Trombolítica/métodos , Adulto , Factor VIII/administración & dosificación , Factor VIII/uso terapéutico , Fibrinógeno/administración & dosificación , Fibrinógeno/metabolismo , Fibrinógeno/uso terapéutico , Humanos , Infarto de la Arteria Cerebral Media/metabolismo , Masculino , Ácido Tranexámico/administración & dosificación , Ácido Tranexámico/uso terapéutico , Resultado del Tratamiento

RESUMEN

PURPOSE:: To analyze the use of this sponge in pediatric patients undergoing split-liver transplantation. METHODS:: Retrospective study, including 35 pediatric patients undergoing split-liver transplantation, divided into two groups according to the use of the sponge: 18 patients in Group A (no sponge) and 17 in Group B (with sponge). RESULTS:: The characteristics of recipients and donors were similar. We observed greater number of reoperation due to bleeding in the wound area in Group A (10 patients - 55.5%) than in Group B (3 patients - 17.6%); p = 0.035. The median volume of red blood cells transfused in Group A was significantly higher (73.4 ± 102.38 mL/kg) than that in Group B (35.1 ± 41.67 mL/kg); p = 0.048. Regarding bile leak there was no statistical difference. CONCLUSION:: The use of the human fibrinogen and thrombin sponge, required lower volume of red blood cell transfusion and presented lower reoperation rates due to bleeding in the wound area.

Asunto(s)

Fibrinógeno/uso terapéutico , Hemostasis Quirúrgica/métodos , Hemostáticos/uso terapéutico , Trasplante de Hígado/métodos , Tapones Quirúrgicos de Gaza , Trombina/uso terapéutico , Pérdida de Sangre Quirúrgica/prevención & control , Transfusión de Eritrocitos , Femenino , Hepatectomía/métodos , Humanos , Lactante , Hígado/cirugía , Trasplante de Hígado/efectos adversos , Masculino , Reoperación , Reproducibilidad de los Resultados , Estudios Retrospectivos , Estadísticas no Paramétricas , Herida Quirúrgica/tratamiento farmacológico , Resultado del Tratamiento

RESUMEN

Purpose: To analyze the use of this sponge in pediatric patients undergoing split-liver transplantation. Methods: Retrospective study, including 35 pediatric patients undergoing split-liver transplantation, divided into two groups according to the use of the sponge: 18 patients in Group A (no sponge) and 17 in Group B (with sponge). Results: The characteristics of recipients and donors were similar. We observed greater number of reoperation due to bleeding in the wound area in Group A (10 patients - 55.5%) than in Group B (3 patients - 17.6%); p = 0.035. The median volume of red blood cells transfused in Group A was significantly higher (73.4 ± 102.38 mL/kg) than that in Group B (35.1 ± 41.67 mL/kg); p = 0.048. Regarding bile leak there was no statistical difference. Conclusion: The use of the human fibrinogen and thrombin sponge, required lower volume of red blood cell transfusion and presented lower reoperation rates due to bleeding in the wound area.(AU)

Asunto(s)

Humanos , Trasplante de Hígado , Fibrinógeno/uso terapéutico , Homeostasis

RESUMEN

Abstract Purpose: To analyze the use of this sponge in pediatric patients undergoing split-liver transplantation. Methods: Retrospective study, including 35 pediatric patients undergoing split-liver transplantation, divided into two groups according to the use of the sponge: 18 patients in Group A (no sponge) and 17 in Group B (with sponge). Results: The characteristics of recipients and donors were similar. We observed greater number of reoperation due to bleeding in the wound area in Group A (10 patients - 55.5%) than in Group B (3 patients - 17.6%); p = 0.035. The median volume of red blood cells transfused in Group A was significantly higher (73.4 ± 102.38 mL/kg) than that in Group B (35.1 ± 41.67 mL/kg); p = 0.048. Regarding bile leak there was no statistical difference. Conclusion: The use of the human fibrinogen and thrombin sponge, required lower volume of red blood cell transfusion and presented lower reoperation rates due to bleeding in the wound area.

Asunto(s)

Humanos , Masculino , Femenino , Lactante , Fibrinógeno/uso terapéutico , Hemostáticos/uso terapéutico , Trombina/uso terapéutico , Tapones Quirúrgicos de Gaza , Trasplante de Hígado/métodos , Hemostasis Quirúrgica/métodos , Reoperación , Reproducibilidad de los Resultados , Estudios Retrospectivos , Pérdida de Sangre Quirúrgica/prevención & control , Trasplante de Hígado/efectos adversos , Resultado del Tratamiento , Transfusión de Eritrocitos , Estadísticas no Paramétricas , Herida Quirúrgica/tratamiento farmacológico , Hepatectomía/métodos , Hígado/cirugía

RESUMEN

March 2013 represented the 50th anniversary of the first license granted for a fibrinogen concentrate. In this review, we look at the history of bleeding management that led to the development of fibrinogen concentrate, discuss its current use, and consider future developments for this product.

Asunto(s)

Fibrinógeno/uso terapéutico , Hemorragia/tratamiento farmacológico , Aniversarios y Eventos Especiales , Fibrinógeno/historia , Hemorragia/historia , Historia del Siglo XX , Historia del Siglo XXI , Humanos

RESUMEN

OBJECTIVES: Acute acquired hypofibrinogenemia in children undergoing cardiac surgery is a major concern because it often results in perioperative bleeding and high rates of allogeneic blood transfusion. Fibrinogen concentrate has been proposed as an alternative to cryoprecipitate (the gold standard therapy), with minimal infectious and immunologic risks. Our objective was to investigate the efficacy and safety of fibrinogen concentrate in children undergoing cardiac surgery. METHODS: In this randomized pilot study, patients were allocated to receive fibrinogen concentrate (60 mg/kg) or cryoprecipitate (10 mL/kg) if bleeding was associated with fibrinogen levels<1 g/dL after cardiopulmonary bypass weaning. The primary outcome was postoperative blood losses during the 48 hours after surgery. RESULTS: A total of 63 patients were included in the study, 30 in the fibrinogen concentrate group and 33 in the cryoprecipitate group. The median 48-hour blood loss was not significantly different between the 2 groups (320 mL [interquartile range, 157-750] vs 410 mL [interquartile range, 215-510], respectively; P=.672). After treatment, plasma fibrinogen concentration increased similarly following administration of both products. There were no differences in allogeneic blood transfusion after intervention treatment. CONCLUSIONS: A large trial comparing fibrinogen concentrate and cryoprecipitate in the management of children with acute acquired hypofibrinogenemia during heart surgery is feasible. The preliminary results of our study showed that the use of fibrinogen concentrate was as efficient and safe as cryoprecipitate in the management of bleeding children undergoing cardiac surgery.

Asunto(s)

Procedimientos Quirúrgicos Cardíacos , Factor VIII/uso terapéutico , Fibrinógeno/uso terapéutico , Pruebas de Coagulación Sanguínea , Pérdida de Sangre Quirúrgica , Brasil , Puente Cardiopulmonar , Niño , Preescolar , Transfusión de Eritrocitos/estadística & datos numéricos , Femenino , Humanos , Lactante , Masculino , Proyectos Piloto , Estudios Prospectivos , Resultado del Tratamiento

RESUMEN

This article presents the case of a young woman with massive hemoptysis (1,000 mL in 6 hours) due to tuberculosis, which could not be controlled by insertion of a Fogarty catheter through a fiber-optic bronchoscope. Because of asphyxia and persistent bleeding risk we instilled fibrinogen-thrombin through a fiber-optic bronchoscope inserted catheter, achieving bleeding cessation and permitting the placing of a double-lumen oro-tracheal tube. Later on, the patient underwent lobectomy and anti-tuberculosis treatment. The fibrinogen-thrombin could be considered as a bridge, transitory measure for massive hemoptysis, while definitive treatment could be established.

Asunto(s)

Aprotinina/uso terapéutico , Factor XIII/uso terapéutico , Adhesivo de Tejido de Fibrina/uso terapéutico , Fibrinógeno/uso terapéutico , Hemoptisis/terapia , Técnicas Hemostáticas , Trombina/uso terapéutico , Adulto , Antituberculosos/uso terapéutico , Aprotinina/administración & dosificación , Oclusión con Balón , Broncoscopía/métodos , Catéteres , Colangiopancreatografia Retrógrada Endoscópica/instrumentación , Terapia Combinada , Combinación de Medicamentos , Urgencias Médicas , Factor XIII/administración & dosificación , Femenino , Tecnología de Fibra Óptica , Adhesivo de Tejido de Fibrina/administración & dosificación , Fibrinógeno/administración & dosificación , Hemoptisis/etiología , Hemoptisis/cirugía , Técnicas Hemostáticas/instrumentación , Humanos , Intubación Intratraqueal/instrumentación , Neumonectomía , Trombina/administración & dosificación , Tuberculosis Pulmonar/complicaciones , Tuberculosis Pulmonar/tratamiento farmacológico , Tuberculosis Pulmonar/cirugía

RESUMEN

Se presenta el caso de una paciente joven con hemoptisis masiva por tuberculosis que no pudo ser controlada de forma efectiva con la inserción de un catéter Fogarty por un fibrobroncoscopio. Ante esto y el alto riesgo de asfixia o desangramiento, se decidió infundir fibrinógeno-trombina a través de un catéter, introducido por el fibrobroncoscopio; con esto se logró controlar el sangrado, intubarla con un tubo orotraqueal de doble luz y estabilizarla para remitirla a otra institución, donde fue sometida a lobectomía y se le proporcionó tratamiento antituberculoso. La infusión de fibrinógeno-trombina podría considerarse como una opción terapéutica transitoria, de tipo puente, mientras se practica el manejo definitivo.

---

This article presents the case of a young woman with massive hemoptysis (1,000 mL in 6 hours) due to tuberculosis, which could not be controlled by insertion of a Fogarty catheter through a fiber-optic bronchoscope. Because of asphyxia and persistent bleeding risk we instilled fibrinogen-thrombin through a fiber-optic bronchoscope inserted catheter, achieving bleeding cessation and permitting the placing of a double-lumen oro-tracheal tube. Later on, the patient underwent lobectomy and anti-tuberculosis treatment. The fibrinogen-thrombin could be considered as a bridge, transitory measure for massive hemoptysis, while definitive treatment could be established.

Asunto(s)

Adulto , Femenino , Humanos , Aprotinina/uso terapéutico , Factor XIII/uso terapéutico , Adhesivo de Tejido de Fibrina/uso terapéutico , Fibrinógeno/uso terapéutico , Técnicas Hemostáticas , Hemoptisis/terapia , Trombina/uso terapéutico , Antituberculosos/uso terapéutico , Aprotinina/administración & dosificación , Oclusión con Balón , Broncoscopía/métodos , Catéteres , Terapia Combinada , Colangiopancreatografia Retrógrada Endoscópica/instrumentación , Combinación de Medicamentos , Urgencias Médicas , Tecnología de Fibra Óptica , Factor XIII/administración & dosificación , Adhesivo de Tejido de Fibrina/administración & dosificación , Fibrinógeno/administración & dosificación , Hemoptisis/etiología , Hemoptisis/cirugía , Técnicas Hemostáticas/instrumentación , Intubación Intratraqueal/instrumentación , Neumonectomía , Trombina/administración & dosificación , Tuberculosis Pulmonar/complicaciones , Tuberculosis Pulmonar/tratamiento farmacológico , Tuberculosis Pulmonar/cirugía

RESUMEN

The von Willebrand disease (vWD) is a hereditary coagulopathy. There is no gender predilection. Clinically characterized by mucocutaneous bleeding, especially nose bleeding, menorrhagia and bleeding after trauma. This article reports a case of a 52-year-old Caucasian male patient with vWD, who presented with extensive bleeding in the tongue after a lacerating injury caused by accidental biting, and describes some clinical, pathological and treatment aspects of vWD. After repeated attempts to suture the wound and replace clotting factors, a decision was made to perform the ligature of the external carotid artery ipsilateral to the injury. There was favorable resolution of the case, with a good aspect of the scar 2 months after ligation. This case reinforces that it is extremely important to make a thorough review of medical history of all patients, searching for possible bleeding disorders or previous family history.

Asunto(s)

Arteria Carótida Externa/cirugía , Técnicas Hemostáticas , Enfermedades de von Willebrand/cirugía , Factor IX/uso terapéutico , Factor VIII/uso terapéutico , Fibrinógeno/uso terapéutico , Humanos , Laceraciones/complicaciones , Ligadura , Masculino , Persona de Mediana Edad , Hemorragia Bucal/etiología , Hemorragia Bucal/cirugía , Técnicas de Sutura , Lengua/lesiones , Factor de von Willebrand/uso terapéutico

RESUMEN

The von Willebrand disease (vWD) is a hereditary coagulopathy. There is no gender predilection. Clinically characterized by mucocutaneous bleeding, especially nose bleeding, menorrhagia and bleeding after trauma. This article reports a case of a 52-year-old Caucasian male patient with vWD, who presented with extensive bleeding in the tongue after a lacerating injury caused by accidental biting, and describes some clinical, pathological and treatment aspects of vWD. After repeated attempts to suture the wound and replace clotting factors, a decision was made to perform the ligature of the external carotid artery ipsilateral to the injury. There was favorable resolution of the case, with a good aspect of the scar 2 months after ligation. This case reinforces that it is extremely important to make a thorough review of medical history of all patients, searching for possible bleeding disorders or previous family history.

---

A doença de von Willebrand (DvW) é uma coagulopatia hereditária. Não há predileção por sexo. Clinicamente caracteriza-se por hemorragias mucocutâneas, sobretudo nasais, menorragias e hemorragias pós-trauma. Este artigo relata um caso clínico de DvW em paciente de 52 anos de idade, leucoderma, do sexo masculino, que apresentou extensa hemorragia em bordo lateral de língua após ferimento lacerante, além de descrever alguns aspectos clínicos, patológicos e terapêuticos da DvW. Após repetidas tentativas de sutura do ferimento e reposição dos fatores de coagulação, optou-se pela ligadura da artéria carótida externa ipsilateral ao ferimento, com resolução favorável do caso, notando-se bom aspecto cicatricial 2 meses após a ligadura. Este caso reforça que é de extrema importância a realização de anamnese criteriosa, buscando-se identificar possíveis distúrbios hemorrágicos prévios ou antecedentes familiares.

Asunto(s)

Humanos , Masculino , Persona de Mediana Edad , Arteria Carótida Externa/cirugía , Técnicas Hemostáticas , Enfermedades de von Willebrand/cirugía , Factor IX/uso terapéutico , Factor VIII/uso terapéutico , Fibrinógeno/uso terapéutico , Ligadura , Laceraciones/complicaciones , Hemorragia Bucal/etiología , Hemorragia Bucal/cirugía , Técnicas de Sutura , Lengua/lesiones , Factor de von Willebrand/uso terapéutico

RESUMEN

Cystic retroperitoneal lymphangioma is an unfrequent pathology. Most cases are asymptomatic, and when symptomatic, they tend to present as abdominal pain and bowel obstruction secondary to compres-sion of the bowel loops. Treatment of choice is surgical excisión. We present a case of cystic retroperitoneal lymphangioma with adhesions to the second portion of duodenum and head of the pancreas. Once separated from the pancreas, it remained denudated. To avoid an eventual pancreatic fístula, Tachosil® was placed as sealing method. Postoperative course was uneventful.

---

El linfangioma quístico retroperitoneal es una patología de poca frecuencia. La mayoría de los casos son asintomáticos y cuando presentan síntomas, lo más frecuente es dolor abdominal u obstrucción intestinal por compresión de asas intestinales. Su tratamiento consiste en la extirpación completa de la lesión. Presentamos un caso de linfangioma quístico retroperitoneal adherido a 2a porción duodenal y cabeza pancreática. Al separarlo del tejido pancreático, quedó un borde cruento. Para evitar una fístula pancreática, se colocó una placa de Tachosil® a modo de sellante. No aparecieron complicaciones postoperatorias.

Asunto(s)

Humanos , Masculino , Adulto , Hemostáticos/uso terapéutico , Linfangioma Quístico/cirugía , Neoplasias Retroperitoneales/cirugía , Tapones Quirúrgicos de Gaza , Drenaje , Combinación de Medicamentos , Fibrinógeno/uso terapéutico , Fístula Pancreática/prevención & control , Resultado del Tratamiento

RESUMEN

El objetivo del presente trabajo fue determinar la relación de las concentraciones de fibrinógeno con factores de riesgo cardiovascular isquémicos en hombres aparentemente sanos de Maracaibo,Venezuela. Se estudiaron 246 hombres aparentemente sanos, con edades entre 31 a 65 años, mediante evaluación médica y de laboratorio. Se determinaron las concentraciones de fibrinógeno por coagulometría, lípidos y glicemia por métodos enzimáticos e insulina por radioinmunoanálisis. El 31,7% se ubicó en el tercil más alto de fibrinógeno (>311 mg/dL) y a su vez presentó valores significativamente superiores de colesterol total (p < 0,03) y de LDL-C (p < 0,01). Además, los individuos ubicados en este tercil mostraron una correlación significativa y positiva entre las concentraciones de triglicéridos y los niveles de insulina (p < 0,02) y HOMA-IR (p < 0,01). Por otra parte, el análisis de correlación demostró también una asociación positiva y significativa entre las concentraciones de fibrinógeno y los niveles de colesterol total (p < 0,02) en el grupo total, a expensas de los sujetos con antecedentes familiares de enfermedad cardiovascular isquémica (colesterol total: p < 0,02 y LDL-C: p < 0,003). En conclusión, las altas concentraciones de fibrinógeno encontradas en el 31,7% de los hombres aparentemente sanos y la positiva y significativa asociación de esta variable con el colesterol total y las lipoproteínas de baja densidad, en los sujetos con antecedentes familiares de enfermedad cardiovascular isquémica, hacen aconsejable incluir el estudio del fibrinógeno en la evaluación cardiovascular de estos últimos individuos en particular.

Asunto(s)

Humanos , Masculino , Adulto , Persona de Mediana Edad , Enfermedades Cardiovasculares/diagnóstico , Enfermedades Cardiovasculares/terapia , Fibrinógeno/efectos adversos , Fibrinógeno/uso terapéutico , Insulina/análisis , Lípidos/análisis

RESUMEN

O pseudo-aneurisma (PSA) após cateterização femoral tem sido diagnosticado com regularidade em serviços com grande movimento de intervenções percutâneas, com incidência variando de 0,05 a 6 por cento. PSA femorais pequenos podem ser acompanhados até a resolução espontânea. As opções de tratamento são: compressão guiada por ultra-som, injeção de trombina para trombose do PSA e tratamento cirúrgico. A injeção percutânea de trombina tem a vantagem de ser um procedimento indolor e rápido. Podem ser utilizados trombina isolada ou preparados contendo trombina associada a fibrinogênio e fatores de coagulação. A experiência inicial dos autores de cinco casos tratados com injeção de adesivo tissular contendo trombina mostrou resultado satisfatório em quatro; um caso necessitou tratamento cirúrgico. Não houve sucesso com uso isolado de trombina humana, porém, ocorreu trombose imediata após injeção de preparado de trombina associada a fibrinogênio/fator XIII. Neste artigo, são discutidas as opções de tratamento dos PSA femorais e a técnica do uso de trombina percutânea.

Asunto(s)

Humanos , Masculino , Femenino , Persona de Mediana Edad , Anciano , Anciano de 80 o más Años , Fibrinógeno/uso terapéutico , Trombina/uso terapéutico , Aneurisma Falso/terapia , Administración Cutánea , Cateterismo/efectos adversos , Arteria Femoral

RESUMEN

Con el presente trabajo se pretendió demostrar que los niveles séricos de fibrinógeno ayudan a predecir la ocurrencia de infarto del miocardio en pacientes con angina inestable. La población estuvo conformada por los pacientes con diagnóstico de angina inestable que acudieron al Hospital Central Dr. Urquinaona de Maracaibo. A una muestra de sesenta pacientes escogidos al azar, de ambos sexos y con una edad mayor o igual a cuarenta años, se les descartó al ser ingresados infarto del miocardio según los criterios de la Organización Mundial de la Salud. Se formaron dos grupos según la evolución clínica: grupo A, pacientes con angina inestable y grupo B, pacientes que desarrollan infarto del miocardio. Se determinaron los niveles séricos de fibrinógeno y CPK-MB al ingreso, a las 24, 48 y 72 horas de evolución (tomas N° 1, 2, 3 y 4 respectivamente). El análisis estadístico se realizó mediante la t de Student, la prueba de Chi cuadrado y el test de correlación de Pearson según correspondiera. El grupo B presentó niveles séricos de fibrinógeno, colesterol y recuento plaquetario significativamente elevados (P<0,0001). En dicho grupo, la elevación de la CPK-MB en las tomas N° 2, 3 y 4 fue significativa (P<0,0001). De igual forma presentaron niveles elevados de fibrinógeno en todas las tomas (P<0,05). Hubo correlación positivas significante entre el fibrinógeno y la CPK-MB (r= 0,663, P<0,0001). Queda claro que la elevación del fibrinógeno al inicio del dolor precordial es un factor de riesgo independiente que indica la evolución de la angina inestable hacia el infarto del miocardio, por lo cual se puede considerar como predictor de evento coronario adverso. El fibrinógeno se elevó primero que la CPK-MB circustancia que determina su posible uso como marcador pronóstico de infarto del miocardio en pacientes con angina inestable. Esta posible función como herramienta pronóstica debería confirmarse con estudios que incluyan mayor número de pacientes

Asunto(s)

Humanos , Masculino , Femenino , Angina Inestable , Fibrinógeno/uso terapéutico , Biomarcadores , Infarto del Miocardio , Medicina , Venezuela