Experimental Evaluation of Chitosan Membrane and Collagen Sponge (TachoSil®) as Sealants in Cardiovascular Surgery

ABSTRACT 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.

Hemostatic efficacy of tranexamic acid and ε-aminocaproic acid in hip and knee arthroplasty:a Meta-analysis / 中国骨伤

OBJECTIVE@#To systematically evaluate the hemostatic efficacy of tranexamic acid and ε-aminocaproic acid in total hip arthroplasty (THA) and total knee arthroplasty (TKA).@*METHODS@#Randomized controlled trials (RCT) and retrospective case-control studies about tranexamic acid and ε-aminocaproic acid for the comparison of THA or TKA were searched electronically in PubMed, EMbase, Cochrane Library, China National Knowledge Infrastructure (CNKI), Wanfang, VIP from the time of building databases to July 2020. Two investigators carried out literature screening and data extraction according to the inclusion and exclusion criteria respectively. The methodological quality of the included randomized controlled studies was evaluated through the Cochrane Handbook, and the methodological quality of the included retrospective case-control studies was evaluated through the NOS scale. Blood loss, the incidence of thrombosis complications, per capita input of hemoglobin were Meta-analyzed by Review Manager 5.3 software.@*RESULTS@#A total of 6 articles were included, including 4 RCTs and 2 retrospective case-control studies. A total of 3 174 patients, including 1 353 in the tranexamic acid group and 1 821 in the ε-aminocaproic acid group. Meta-analysis results showed that there were no difference statistical significance in blood loss [MD=-88.60, 95%CI(-260.30, 83.10), P=0.31], blood transfusion rate [OR=1.48, 95%CI(0.96, 2.27), P=0.08], thrombotic complications [OR=0.80, 95%CI(0.07, 8.83), P=0.85], per capita hemoglobin input [MD=0.04, 95%CI(-0.02, 0.10), P=0.18] between tranexamic acid group and ε-aminocaproic acid group during THA. While in TKA, the blood loss of the tranexamic acid group was less than that of the ε-aminocaproic acid group [MD=-147.13, 95%CI(-216.52, -77.74), P<0.0001], the difference was statistically significant. The blood transfusion rate [OR=1.30, 95%CI(0.74, 2.28), P=0.37], thrombotic complications [OR=0.95, 95%CI(0.38, 2.36), P=0.92], per capita hemoglobin input [MD=-0.00, 95%CI(-0.05, 0.06), P=0.48], tourniquet time [MD=1.54, 95%CI(-2.07, 5.14), P=0.40] were similar between two groups, the difference was not statistically significant.@*CONCLUSION@#In THA, tranexamic acid and ε-aminocaproic acid have similar hemostatic effects, while in TKA, tranexamic acid can effectively reduce the patient's blood loss and has a better hemostatic effect. Tranexamic acid is recommended as one of the first choice hemostatic drugs for TKA.

A gauze-pad wrapping of the heart can save a patient's life

Abstract We describe one case of iatrogenic rupture of the left ventricle after mitral valve replacement and myectomy of the outflow tract. The cause and site of the rupture could not be identified, neither from the internal nor from the external examination. After unsuccessful use of hemostatic patches in the surface of the ruptured area, wrapping of the ventricles with a surgical gauze pad controlled the hemorrhage, hence saving the patient's life.

Damage control surgery in lung trauma / Cirugía de control de daños del trauma pulmonar

Abstract Damage control techniques applied to the management of thoracic injuries have evolved over the last 15 years. Despite the limited number of publications, information is sufficient to scatter some fears and establish management principles. The severity of the anatomical injury justifies the procedure of damage control in only few selected cases. In most cases, the magnitude of the physiological derangement and the presence of other sources of bleeding within the thoracic cavity or in other body compartments constitutes the indication for the abbreviated procedure. The classification of lung injuries as peripheral, transfixing, and central or multiple, provides a guideline for the transient bleeding control and for the definitive management of the injury: pneumorraphy, wedge resection, tractotomy or anatomical resection, respectively. Identification of specific patterns such as the need for resuscitative thoracotomy, or aortic occlusion, the existence of massive hemothorax, a central lung injury, a tracheobronchial injury, a major vascular injury, multiple bleeding sites as well as the recognition of hypothermia, acidosis or coagulopathy, constitute the indication for a damage control thoracotomy. In these cases, the surgeon executes an abbreviated procedure with packing of the bleeding surfaces, primary management with packing of some selected peripheral or transfixing lung injuries, and the postponement of lung resection, clamping of the pulmonary hilum in the most selective way possible. The abbreviation of the thoracotomy closure is achieved by suturing the skin over the wound packed, or by installing a vacuum system. The management of the patient in the intensive care unit will allow identification of those who require urgent reintervention and the correction of the physiological derangement in the remaining patients for their scheduled reintervention and definitive management.

Resumen Las técnicas de control de daños aplicadas al manejo de lesiones torácicas han evolucionado en los últimos 15 años. A pesar de que el número de publicaciones es limitado, la información es suficiente para desvirtuar algunos temores y establecer los principios de manejo. La severidad del compromiso anatómico justifica el procedimiento de control de daños solamente en algunos casos. En la mayoría, la magnitud del deterioro fisiológico y la presencia de otras fuentes de sangrado dentro del tórax o en otros compartimientos corporales constituyen la indicación del procedimiento abreviado. La clasificación de la lesión pulmonar como periférica, transfixiante y central o múltiple, proporciona una pauta para el control transitorio del sangrado y para el manejo definitivo de la lesión: neumorrafía, resección en cuña, tractotomía o resecciones anatómicas, respectivamente. La identificación de ciertos patrones como la necesidad de toracotomía de reanimación o de oclusión aórtica, la existencia de un hemotórax masivo, de una lesión pulmonar central, una lesión traqueobronquial o una lesión vascular mayor, así como el reconocimiento de hipotermia, acidosis o coagulopatía, constituyen la indicación de una toracotomía de control de daños. En estos casos, el cirujano concluye de manera abreviada los procedimientos con empaquetamiento de las superficies sangrantes, el manejo primario con empaquetamiento de algunas lesiones pulmonares periféricas o transfixiante seleccionadas y el aplazamiento de la resección pulmonar, pinzando el hilio de la manera más selectiva posible. La abreviación del cierre de la toracotomía se logra con la sutura de la piel sobre el empaquetamiento de la herida, o mediante la instalación de un sistema de presión negativa. El manejo del paciente en cuidados intensivos permitirá identificar aquellos que requieren reintervención urgente y corregir la alteración fisiológica de los restantes para su reoperación programada y manejo definitivo.

Rectal damage control: when to do and not to do / Control de daños de recto: que hacer y que no hacer

Abstract Rectal trauma is uncommon, but it is usually associated with injuries in adjacent pelvic or abdominal organs. Recent studies have changed the paradigm behind military rectal trauma management, showing better morbidity and mortality. However, damage control techniques in rectal trauma remain controversial. This article aims to present an algorithm for the treatment of rectal trauma in a patient with hemodynamic instability, according to damage control surgery principles. We propose to manage intraperitoneal rectal injuries in the same way as colon injuries. The treatment of extraperitoneal rectum injuries will depend on the percentage of the circumference involved. For injuries involving more than 25% of the circumference, a colostomy is indicated. While injuries involving less than 25% of the circumference can be managed through a conservative approach or primary repair. In rectal trauma, knowing when to do or not to do it makes the difference.

Resumen El trauma de recto es poco frecuente, pero generalmente se asocia a lesiones de órganos adyacentes en la región pélvica y abdominal. Estudios recientes han cambiado los paradigmas del manejo tradicional derivados del trauma militar, mostrando mejores resultados en la morbilidad y mortalidad. Sin embargo, las técnicas de control de daños en el trauma rectal aún son controvertidas. El objetivo de este articulo es proponer el algoritmo de manejo del paciente con trauma rectal e inestabilidad hemodinámica, según los principios de la cirugía de control de daños. Se propone que las lesiones del recto en su porción intraperitoneal sean manejadas de la misma manera que las lesiones del colon. Mientras que el manejo de las lesiones extraperitoneales del recto dependerá del compromiso de la circunferencia rectal. Si es mayor del 25% se recomienda realizar una colostomía. Si es menor, se propone optar por el manejo conservador o el reparo primario. Saber que hacer o que no hacer en el trauma de recto marca la diferencia.

Biological compatibility of oxidized cellulose vs. porcine gelatin to control bleeding in liver lesions in rats

ABSTRACT Purpose: To compare biological compatibility, hemostasis, and adhesion formation between oxidized regenerated cellulose and lyophilized hydrolyzed porcine collagen in liver trauma. Methods: Forty male Wistar rats constituted two groups: group A (oxidized cellulose) and group B (lyophilized hydrolyzed collagen). Standardized liver trauma was made, and the hemostatic agent was applied. Animals in subgroups A7 and B7 were submitted to euthanasia and relaparotomy after seven days, and in subgroups A14 and B14 after 14 days. Macroscopic and microscopic results were evaluated. Results: There was no fluid in the cavity in any of the animals, and adhesions were present in all of them. In the analysis after seven days, the adhesions were grades 3 or 4 and consisted of omentum, small intestine, and abdominal wall (p<0.05). In both groups, the mesh was surrounded by a capsule, which was not observed after 14 days. In the evaluation after 14 days, adhesions were grades 2 or 3 (p>0.05). The microscopic examination showed subacute and chronic reactions, in both groups and in both timepoints, with similar frequency. The intensity of fibrosis always presented positive scores. Microabscesses and xanthomatous macrophages were observed in both groups. Conclusions: There was no superiority of one agent over the other.

Bleeding complication after surgical removal of impacted teeth in a patient with undiagnosed clotting disorder / Complicação de sangramento após remoção cirúrgica de dentes impactados em um paciente com desordem de coagulação não diagnosticado

ABSTRACT To report one case of bleeding episodes after impacted teeth extractions had been performed in a patient with undiagnosed clotting disorder, describing a sequence of approaches for hemostasis up to the appropriated diagnosis and effective resolution. A male 16-year old patient with surgical indication to remove eight impacted teeth. After the surgery, there were bleeding episodes, being needed for hospital admission to keep on his physiological functions, blood pressure and heartbeat frequency regularly, to carry out laboratory blood tests, and to achieve hemostasis by using antifibrinolytics and blood products. After 24 hours, 11% of IX clotting factor was verified into bloodstream by specific blood test, being diagnosed with mild Hemophilia B. From the diagnosis, infusions of IX clotting factor were performed to the adequate resolution and recovery of the patient. The clinical conducts were efficient to keep on stable vital signs and achieving appropriate diagnosis. However, preventive behaviors should be applied in hemophilic patients in pre- or intra-operative, avoiding circumstances that can compromise health condition of the patient.

RESUMO Relatar um caso de episódios de sangramento após remoção de dentes inclusos em paciente com distúrbio de coagulação não diagnosticado, descrevendo uma sequência de condutas para hemostasia até o diagnóstico apropriado e resolução efetiva. Paciente do gênero masculino, 16 anos, com indicação de remoção de 8 dentes inclusos. Após a cirurgia, houve episódios de sangramento, sendo necessária sua internação para integridade das funções orgânicas básicas, realização de exames laboratoriais, controle hemodinâmico e tentativa de obtenção de hemostasia por meio de antifibrinolíticos e hemoderivados. Após 24 horas de internação, 11% do fator IX de coagulação foi verificado na corrente sanguínea por meio de exame específico, sendo o paciente diagnosticado com Hemofilia B de caráter leve. A partir do diagnóstico, infusões do fator deficiente foram realizadas para resolutividade adequada e recuperação do paciente. As condutas realizadas foram eficientes para manutenção dos sinais vitais até a hemostasia obtida após diagnóstico adequado. No entanto, as condutas preventivas devem ser aplicadas em pacientes hemofílicos no pré- ou trans-operatórios, evitando circunstâncias que podem comprometer o estado de saúde do paciente.

Whole blood for blood loss: hemostatic resuscitation in damage control / Sangre total: la nueva alternativa en la resucitación hemostática

Abstract Hemorrhagic shock and its complications are a major cause of death among trauma patients. The management of hemorrhagic shock using a damage control resuscitation strategy has been shown to decrease mortality and improve patient outcomes. One of the components of damage control resuscitation is hemostatic resuscitation, which involves the replacement of lost blood volume with components such as packed red blood cells, fresh frozen plasma, cryoprecipitate, and platelets in a 1:1:1:1 ratio. However, this is a strategy that is not applicable in many parts of Latin America and other low-and-middle-income countries throughout the world, where there is a lack of well-equipped blood banks and an insufficient availability of blood products. To overcome these barriers, we propose the use of cold fresh whole blood for hemostatic resuscitation in exsanguinating patients. Over 6 years of experience in Ecuador has shown that resuscitation with cold fresh whole blood has similar outcomes and a similar safety profile compared to resuscitation with hemocomponents. Whole blood confers many advantages over component therapy including, but not limited to the transfusion of blood with a physiologic ratio of components, ease of transport and transfusion, less volume of anticoagulants and additives transfused to the patient, and exposure to fewer donors. Whole blood is a tool with reemerging potential that can be implemented in civilian trauma centers with optimal results and less technical demand.

Resumen El choque hemorrágico y sus complicaciones son la principal causa de muerte en los pacientes con trauma. La resucitación en control de daños ha demostrado una disminución en la mortalidad y mejoría en el manejo del paciente. La resucitación hemostática consiste en la recuperación del volumen con hemoderivados como glóbulos rojos, plasma, crioprecipitado y plaquetas, en proporciones de 1:1:1:1. Sin embargo, esta demanda de hemo componentes podría no aplicarse para toda Latinoamérica u otros países de medianos y bajos ingresos. Las principales barreras para la implementación de esta estrategia serían la escasa disponibilidad de bancos de sangre y de hemoderivados insuficientes para contar con un protocolo de transfusión masiva. Una propuesta para superar estas barreras es el uso de sangre total fresca fría para la resucitación hemostática de los pacientes exsanguinados. Ecuador ha sido pionero en la implementación de esta estrategia con una experiencia ya de seis años, en que han demostrado que la sangre total tiene ventajas sobre la terapia de hemo componentes incluyendo, pero no limitando, la trasfusión de sangre con una razón fisiológica de componentes, fácil transporte y transfusión, menor volumen de anticoagulantes y aditivos trasfundidos al paciente, y menor exposición a donantes. La sangre total es una herramienta con un potencial reemergente que puede ser implementado en centros de trauma civil con óptimos resultados y menor demanda técnica.

A tromboelastometria identifica coagulopatia associada à insuficiência hepática e coagulação intravascular disseminada causadas por febre amarela, orientando a terapia hemostática específica: um relato de caso / Thromboelastometry identifies coagulopathy associated with liver failure and disseminated intravascular coagulation caused by yellow fever, guiding specific hemostatic therapy: a case report

RESUMO Este relato de caso detalha um caso grave de febre amarela complicada por insuficiência hepática e coagulação intravascular disseminada. A tromboelastometria foi capaz de identificar os distúrbios da coagulação e orientar o tratamento hemostático. Relatamos o caso de um homem com 23 anos de idade admitido na unidade de terapia intensiva com quadro com início abrupto de febre e dor muscular generalizada associados a insuficiência hepática e coagulação intravascular disseminada. Os resultados dos exames laboratoriais convencionais revelaram trombocitopenia, enquanto a tromboelastometria sugeriu coagulopatia com discreta hipofibrinogenemia, consumo de fatores de coagulação e, consequentemente, aumento do risco de sangramento. Diferentemente dos exames laboratoriais convencionais, a tromboelastometria identificou o distúrbio de coagulação específico e, assim, orientou o tratamento hemostático. Administraram-se concentrados de fibrinogênio e vitamina K, não sendo necessária a transfusão de qualquer componente do sangue, mesmo na presença de trombocitopenia. A tromboelastometria permitiu a identificação precoce da coagulopatia e ajudou a orientar a terapêutica hemostática. A administração de fármacos hemostáticos, incluindo concentrados de fibrinogênio e vitamina K, melhorou os parâmetros tromboelastométricos, com correção do transtorno da coagulação. Não se realizou transfusão de hemocomponentes, e não ocorreu qualquer sangramento.

Abstract This case report a severe case of yellow fever complicated by liver failure and disseminated intravascular coagulation. Thromboelastometry was capable of identifying clotting disorders and guiding hemostatic therapy. We report the case of a 23-year-old male admitted to the Intensive Care Unit with sudden onset of fever, generalized muscle pain associated with liver failure, and disseminated intravascular coagulation. The results of conventional laboratory tests showed thrombocytopenia, whereas thromboelastometry suggested coagulopathy with slight hypofibrinogenemia, clotting factor consumption, and, consequently, an increased risk of bleeding. Unlike conventional laboratory tests, thromboelastometry identified the specific coagulation disorder and thereby guided hemostatic therapy. Both fibrinogen concentrates and vitamin K were administered, and no blood component transfusion was required, even in the presence of thrombocytopenia. Administration of hemostatic drugs, including fibrinogen concentrate and vitamin K, improved thromboelastometric parameters, correcting the complex coagulation disorder. Blood component transfusion was not performed, and there was no bleeding.

Saúde bucal em pacientes em terapia anticoagulante e efetividade das terapias hemostáticas para a prevenção do sangramento / Oral health in patients under anticoagulant therapy and effectiveness of hemostatic therapies for bleeding prevention

O objetivo deste trabalho foi determinar a efetividade das terapias hemostáticas em indivíduos sob terapia anticoagulante a fim de evitar o sangramento por procedimentos odontológicos e descrever os fatores associados à qualidade de vida e saúde bucal entre pacientes em terapia anticoagulante oral com varfarina. Inicialmente foi desenvolvida uma revisão sistemática e meta-analise em rede que revisou os ensaios clínicos em diferentes bases de dados para determinar a efetividade das terapias hemostáticas. A extração de dados, a avaliação do risco de viés dos artigos incluídos (ferramentas de JBI e Cochrane) e a avaliação da certeza das evidências (GRADE) foram realizadas. Como resultados, foi verificado que o N-butil-2-cianoacrilato [RR -35,00 (95% CI - 107,12, -5,78)], sulfato de cálcio (CaSO4) [RR -5,62 (95% CI -11,41, -1,03)], e Ácido tranexâmico (TXA) [RR -3,46 (95% CI -7,63, -0,77)] mostraram efeitos benéficos em comparação com o placebo. No entanto, apenas o TXA apresentou efeitos benéficos com evidência de certeza moderada. N-butil-2-cianoacrilato e CaSO4 apresentaram evidência de certeza muito baixa. Não foram observadas diferenças entre agentes hemostáticos na prevenção de eventos de sangramento. Concluindo, os eventos de sangramento em indivíduos em anticoagulação oral diminuíram com o uso de TXA em comparação com o placebo. O N-butil-2-cianoacrilato e o CaSO4 também foram superiores ao placebo, mas a certeza das evidências era baixa. Para o tempo médio de sangramento, não foi observada diferença significativa nos agentes hemostáticos. Por outro lado, foi desenvolvido um estudo transversal, questionários validados avaliaram doença periodontal auto-relatada, variáveis demográficas e qualidade de vida relacionada à saúde bucal (QVRSB), usando a versão curta do instrumento Oral Health Impact Profile (OHIP-14), em pacientes anticoagulados de um Hospital de Belo Horizonte, Brasil. Após a calibração intra-examinador (Kappa = 0,95), um examinador avaliou a experiência dos pacientes com cárie dentária e a necessidade de próteses dentárias. A análise estatística envolveu proporções e medidas de tendência central. Modelos de regressão binomial negativos foram usados para estimar as razões de taxas (RR) e os intervalos de confiança de 95% (IC) correspondentes. A média do OHIP-14 foi de 10,62 (DP = 10,92). Um escore total do OHIP-14 mais alto (baixa QVRSB) foi associado ao grupo étnico, idade, auto-relato de doença periodontal, cárie dentária e auto-relato de saúde bucal. Concluindo, as doenças bucais entre indivíduos submetidos a terapia anticoagulante oral com varfarina é preocupante. Os fatores demográficos e clínicos têm uma influência na percepção de pacientes anticoagulados na QVRSB.

This study aimed to determine the effectiveness of hemostatic protocols in anticoagulated patients to prevent bleeding in dental procedures and describe the factors associated with quality of life and oral health-related to patients undergoing oral anticoagulant therapy with warfarin. In the first instance, in the systematic review and network meta-analysis, a search of the literature was conducted in different databases where clinical trials were evaluated to determine the effectiveness of hemostatic protocols. Data extraction and assessment of the risk of bias (JBI and Cochrane tools) of the included articles were performed. Assessment of the certainty of the evidence (GRADE) was also performed. As results we find that the N-butyl-2-cyanoacrylate [RR -35.00 (95% CI - 107.12, -5.78)], calcium sulfate (CaSO4) [RR -5.62 (95% CI -11.41, -1.03)], and tranexamic acid (TXA) [RR -3.46 (95% CI -7.63, -0.77)] showed beneficial effects compared to placebo. However, only TXA presented beneficial effects with moderate certainty evidence. N-butyl-2-cyanoacrylate and CaSO4 presented very low certainty evidence. No differences were observed between hemostatic agents in preventing bleeding events. Concluding, the bleeding events in individuals on oral anticoagulation decreased with the use of TXA compared to placebo. N-butyl-2-cyanoacrylate and CaSO4 were also superior to placebo, but the certainty of the evidence was low. For the mean bleeding time, no significant difference in hemostatic agents was observed. On the other hand, a the cross-sectional study was performed, validated questionnaires assessed self-reported periodontal disease, demographic variables, and OHRQoL, using the short version of the Oral Health Impact Profile (OHIP-14) instrument in anticoagulated patients at a Belo Horizonte, Brazil. After calibration (Kappa = 0,95), an examiner evaluated patients' experience with dental caries and the need for dental prostheses. Statistical analysis involved proportions and measures of central tendency. Negative binomial regression models were used to estimate the rate ratios (RR) and the corresponding 95% confidence interval (CI). The OHIP-14 mean was 10.62 (SD = 10.92). A higher OHIP-14 total score (low OHRQoL) was associated with an ethnic group, age, periodontal disease self-report, dental caries, and oral health self-report. Concluding, the burden of oral diseases among individuals undergoing OAT is worrisome. Additionally, demographic and clinical factors have an influence on the perception of anticoagulated patients on OHRQoL.

Wound healing effect of regenerated oxidized cellulose versus fibrin sealant patch: An in vivo study

BACKGROUND: Topical hemostatic agents are used when ligation, electrocauterization, or other conventional hemostatic methods are impractical. Because a hemostatic agent is a foreign body, it can cause foreign body reactions, inflammation, and infections that can interfere with the wound healing process. Therefore, we should select hemostatic agents after considering their effects on wound healing. Here, we compared the effects of hemostatic agents on wound healing in a rectus abdominis muscle defect in rats. METHODS: Twelve Sprague Dawley rats were subjected to creation of a 6 × 6 mm defect in the rectus abdominis muscle and divided into four groups: control group; group A, Tachosil fibrin sealant patch; group B, Surgicel Fibrillar oxidized regenerated cellulose; and group C, Surgicel Snow oxidized regenerated cellulose. For the histologic analysis, biopsies were performed on the 3rd, 7th, and 27th days. RESULTS: The foreign body reaction was the weakest in group A and most significant in group C. The inflammatory cell infiltration was the weakest in group A and similar in groups B and C. Muscle regeneration differed among periods. The rats in group A were the most active initially, while those in group C showed prolonged activity. CONCLUSION: Tachosil and Surgicel administration increased inflammation via foreign body reactions, but the overall wound healing process was not significantly affected. The increased inflammation in the Surgicel groups was due to a low pH. We recommend using Tachosil, because it results in less intense foreign body reactions than Surgicel and faster wound healing due to the fibrin action.

Eficácia da celulose oxidada regenerada no controle do sangramento de feridas neoplásicas malignas decorrentes de câncer de mama: ensaio clínico randomizado / Efficacy of oxidized regenerated celulose versus calcium alginate in the control of bleeding from malignant wounds in breast cancer: a Randomized Clincal Trial

Introdução: Feridas neoplásicas malignas (FNM) apresentam sangramento decorrente da angiogênese tumoral ou do rompimento de vasos sanguíneos adjacentes. Ainda hoje, a hemostasia tópica é orientada pela opinião de especialistas tendo como curativo padrão o alginato de cálcio (AC). A celulose oxidada regenerada (COR) é um hemostático cirúrgico e também está indicada para hemostasia em FNM. Não há fortes evidências sobre o emprego destes na hemostasia clínica de FNM. Objetivo geral: Avaliar a eficácia da COR versus o AC no controle do sangramento de FNM decorrente de câncer de mama. Método: Ensaio clínico randomizado, estratificado, paralelo, controlado, aberto, unicêntrico, conduzido entre outubro de 2017 e agosto de 2018, recrutando pacientes no Instituto Nacional de Câncer INCA. Selecionaram-se 13 mulheres ao grupo AC e 15 ao grupo COR com FNM sangrantes, decorrentes de câncer de mama, com idade igual ou superior a 18 anos. Os principais critérios de exclusão foram: presença de sangramento arterial, comorbidades hematológicas e participação anterior no mesmo estudo. As principais variáveis dependentes foram: obtenção de hemostasia, tempo total para hemostasia (TTH), ressangramento e quantidade de produtos hemostáticos utilizados. As principais variáveis independentes foram: número de plaquetas, coagulograma estadiamento do tumor, da FNM e do sangramento. A hipótese afirmou haver diferença média de 5 minutos na utilização da COR comparada ao AC. A intervenção consistiu na aplicação dos produtos, de acordo com a randomização (por envelopes opacos) e contagem do TTH, precedida de coleta de sangue, aferição de sinais vitais e avaliação da ferida e sangramento. O desfecho primário foi o TTH e os secundários: proporção de mulheres que alcançaram hemostasia até 20 minutos; hemostasia aos 3, 5 e 10 minutos, ressangramento e quantidade de hemostáticos. Aplicou-se estatística descritiva para as variáveis nominais e ordinais, por meio de frequências absolutas; para as contínuas: média e desvio-padrão. Os desfechos foram avaliados pelo modelo de riscos de Cox, curva Kaplan Meier e teste Long-rank, para o TTH. O estudo foi aprovado pelos Comitês de Ética em Pesquisa do INCA (Parecer número: 2.2286.120) e da Escola de Enfermagem da Universidade de São Paulo EEUSP (Parecer número: 2.286.120). Resultados: O TTH apresentou mediana 30,4 (IC 95%: 21,7 limite superior impreciso) no grupo AC e mediana 30,1 (IC 95%: 18,6 189) no grupo COR, sem significância estatística (p=0,894). Aos 3 minutos, 92 % (12/13) pacientes do grupo AC alcançaram a hemostasia e 85% (12/14) no grupo COR. No 5º minuto, os resultados se mantiveram em ambos os grupos e no 10º minuto, 100% (13/13) alcançaram a hemostasia no grupo AC e 93% (13/15) no grupo COR. Houve dois ressangramentos no grupo COR. Foram gastos 16 hemostáticos no grupo AC e 36 no grupo COR. Não houve danos/efeitos adversos. Conclusões: Não houve evidência de diferença de eficácia hemostática entre os grupos. Sugerem-se novos estudos com amostras maiores.

Introduction: Malignant wounds (MW) present bleeding due to tumor angiogenesis or the rupture of adjacent blood vessels. Topical hemostasis is recommended by expert opinion. Regenerated oxidized cellulose (ROC) and alginate calcium (AC) are indicated for surgical hemostasis and there is no robust evidence for its use in the control of MW bleeding. Overall objective: To evaluate the efficacy of ROC versus AC in the control of bleeding in malignant wounds due to breast cancer. Method: A randomized, stratified, parallel, controlled, open, unicentric clinical trial was conducted from October 2017 to August 2018, recruiting patients at the National Cancer Institute INCA. We selected 13 women for the control group and 15 for the ROC group, with bleeding MW due to breast cancer, aged 18 years or older. The main exclusion criteria were: presence of arterial bleeding or contraindication to topical hemostasis, hematological comorbidities and previous participation in the same study. The main dependent variables were: hemostasis, total time for hemostasis (TTH), rebleeding and amount of hemostatic products used. The main independent variables were: number of platelets, coagulogram, and tumor, MW and bleeding staging. The hypothesis stated that there was an average difference of five minutes in the use of ROC compared to the standard dressing. The intervention consisted of random (using opaque envelopes) administration of the products and TTH counting, preceded by blood collection, vital signs measurement and evaluation of the wound and bleeding. The primary endpoint was TTH; secondary endpoints were: proportion of women who achieved hemostasis before 20 minutes, hemostasis at three, five and 10 minutes, rebleeding and amount of hemostatic dressings used. Descriptive statistics were applied for nominal and ordinal variables, by means of absolute frequencies; for the continuous ones: mean and standard deviation. The endpoints were evaluated using the Cox risk model, Kaplan Meier curve and Long-rank test for the TTH. The study was approved by the Research Ethics Committees of INCA (Opinion number: 2.2286.120) and the School of Nursing of the University of São Paulo EEUSP (Opinion number: 2.286.120). Results: TTH was median of 30.4 (95% CI: 21.7 imprecise upper limit) in the AC group and median of 30.1 (95% CI: 18.6 189) in the ROC group. The mean difference between the groups was 0.5 minutes, with no statistical significance (p = 0.897). At 3 minutes, 92% (12/13) patients in the AC group and 85% (12/14) of the ROC group had reached hemostasis. From In the 5 minute the result remained and from minutes 10, 100% (13/13) achieved haemostasis in the AC group and 93% (13/15) in the ROC group. There were two rebleedings in the ROC group. EIghteen hemostatic dressings were used in the control group and 34 in the ROC group. There were no damages/adverse effects. Conclusions: There was no evidence of a difference in hemostatic efficacy between groups. Further studies with larger samples are suggested.

Injecting hemostatic matrix in the path of biopsies: efficacy, potential complications, and the management of such complications / Injeção de matrizes hemostáticas no trajeto de biópsias: eficácia, possíveis complicações e o manejo dessas complicações

Abstract Objective: To describe the technique of injecting hemostatic matrix, as well as the experience of our interventional radiology department in its application. Materials and Methods: We conducted a single-center study with retrospective analysis of the experience of our group in the use of hemostatic gelatin matrix in percutaneous biopsies. Results: In a total of 73 biopsies in different organs, such as the liver, kidney, and spleen, hemostatic gelatin matrix was introduced into the coaxial needle. The only complication observed was migration of the hemostatic matrix to the left kidney collecting system, and that was resolved with clinical treatment. There were no cases of bleeding after the injection of hemostatic matrix. Conclusion: The use of hemostatic matrices in the path of percutaneous biopsies is another tool available for consideration in minimally invasive procedures.

Resumo Objetivo: Descrever a técnica de injeção de matrizes hemostáticas e a experiência do nosso serviço de radiologia intervencionista na sua aplicação. Materiais e Métodos: Foi realizado estudo unicêntrico com análise retrospectiva da experiência do nosso grupo na utilização de matriz hemostática gelatinosa em biópsias percutâneas. Resultados: Foram realizadas 73 biópsias com utilização de matriz hemostática gelatinosa no trajeto da agulha coaxial em diferentes órgãos, como fígado, rim, baço, entre outros. A única complicação observada foi a migração da matriz hemostática para o sistema coletor do rim esquerdo, sendo solucionada com tratamento clínico. Não foram observados casos de sangramento no trajeto das biópsias após a injeção de matrizes hemostáticas. Conclusão: O uso de matrizes hemostáticas no trajeto de biópsias percutâneas é mais uma ferramenta disponível a ser considerada nos procedimentos minimamente invasivos.

Comparison of hemostatic efficacy and cytotoxicity of three ferric subsulfate- and chitosan-based styptics in different formulations using a rat tail bleeding model / 대한수의학회지

This study was conducted to compare the hemostatic efficacy of three ferric subsulfate- and chitosan-based styptics as a powder and a gel containing ferric subsulfate and chitosan (FSC-PO and FSC-G, respectively) and a soaked pad containing ferric subsulfate and lidocaine (FSL-SP) using a rat tail bleeding model. The cytotoxicity of the styptics against L-929 mouse fibroblasts was also evaluated using a cell counting kit-8 assay. Four groups of 10 rats each were assigned to the three different styptics and a non-treated control groups. Rat tail tips were transected, after which styptics were applied with pressure. The wounds were observed for hemostasis for 3 min, then irrigated with saline to check for recurrent hemorrhage. L-929 mouse fibroblasts were exposed to extracts of the styptics (100 mg/mL) and their dilutions (1:10, 1:100, and 1:1,000). FSC-PO and FSC-G more effectively controlled initial hemorrhage than FSL-SP (p = 0.033). Additionally, FSC-PO and FSC-G more effectively maintained hemostasis than the control group (p = 0.02 and p < 0.01, respectively). However, all styptics showed enhanced cytotoxicity against L-929 cells in a dose-dependent manner. Therefore, although FSC-PO and FSC-G would be recommended to control hemorrhage, the benefits of styptics must be balanced against the clinical significance of their cytotoxicity.

Application and Rationality Evaluation of Hemostatic Drugs in the Patients with Subarachnoid Hemorrhage / 中国药师

Objective:To investigate the current use situation of hemostatics in preventing re-bleeding in the patients with sub-arachnoid hemorrhage. Methods:The records of patients with subarachnoid hemorrhage were selected from a hospital in 2016 and the types,dosage,course and drug adverse reactions of hemostatics were recorded and evaluated according to the drug information leaflets/related guideline,drug utilization researches and adverse drug actions monitoring. Results:Totally 81 cases with hemostatics involved 3 varieties of hemostatic drugs,the combination proportion was 16.05%,the reasonable use rate was 86.42%,the reasonable rate of administration route was 100%,the reasonable solvent rate was 98.77% and the course no more than 72 h was 88.89%. The drug uti-lization index of etamsylate injection and tranexamic acid injection was greater than one,indicating that the dosage was unreasonable. There were no adverse reactions in the 81 cases.Conclusion:The use of hemostatics in the patients with subarachnoid hemorrhage is common,and there is still unreasonable use (such as dosage and course etc) that we should pay attention to.

Research of Huangong decoction combined with routine treatment of western medicine for the postpartum hemorrhage and fundus reduced height of the postpartum hemorrhage / 国际中医中药杂志

Objective To research of Huangong decoction combined with routine treatment of western medicine for the postpartum hemorrhage and fundus reduced height of the postpartum hemorrhage (PPH). Methods A total of 242 patients with postpartum hemorrhage were enrolled and divided into two group by random number table: the treatment group (121 patients) and the control group (121 patients). Patients in the control group were treated with the western medicine routine treatment, while the treatment group were treated with Huangong decoction plus routine treatment. Both groups were treated for 3 days with a follow-up of 42 d. The postpartum haemorrhage amount, fundus height reduction were compared. The clinical effect rate was evaluated with postpartum haemorrhage amount, palace at the uterine bottom of the height reduction. Results The total clinical effectiveness rate of the treatment group was 97.5% (118/121), and the control group was 90.1%(109/121). The difference of two groups was statistically significant (χ2=4.478, P=0.034). After production, the uterine bottom height reduction at the first day (9.3 ± 1.4 mm vs. 8.0 ± 1.3 mm, t=7.501), the second day (10.2 ± 1.2 mm vs. 9.1 ± 1.1 mm, t=7.447) and the third day (12.2 ± 1.5 mm vs. 10.1±1.4 mm, t=11.283) in the treatment group were significantly greater than the control group (P<0.01). The postpartum hemorrhage at the first day (732.1 ± 84.3 ml vs. 766.4 ± 90.0 ml, t=-3.066), the second day (480.1 ± 62.0 ml vs. 590.0 ± 74.3 ml, t=-12.513) and the third day (240.4 ± 36.3 ml vs. 340.3 ± 52.0 ml, t=-17.351) in the treatment group were significantly less than the control group (P<0.01). After postpartumt, the uterine volume (632.1 ± 101.2 mm3 vs. 701.4 ± 135.7 mm3, t=-5.095) at third day and (142.3 ± 16.5 mm3 vs. 160.6 ± 19.7 mm3, t=-7847) at the follow-up, in the treatment group were significantly less than the control group (P<0.01). Conclusions The Huangong decoction combined with routine treatment of western medicine can improve the clinical symptoms in patients with PPH, and contribute to the recovery of disease.

Indicaciones del factor VII recombinante activado en hemorragia obstétrica grave / Use of recombinant activated Factor VII in severe obstetric hemorrhage

Resumen OBJETIVO: Describir la situación final de salud de las pacientes con hemorragia obstétrica grave (≥ 1000 mL) en quienes se indicó factor VII recombinante activado como parte del tratamiento e identificar las complicaciones atribuibles a este medicamento. MATERIALES Y MÉTODOS: Estudio retrospectivo, transversal y descriptivo efectuado en pacientes con hemorragia obstétrica grave atendidas en el Hospital Civil de Guadalajara Dr. Juan I Menchaca entre 2001 y 2017 y tratadas con factor VII recombinante activado. Se identificaron los antecedentes de importancia y se calculó la dosis promedio y cantidad de dosis de factor VII recombinante activado; se valoró la respuesta hemostática y se determinó si la diferencia en cantidad de sangrado, administración de hemoderivados y parámetros hematológicos antes y después de utilizar factor VII recombinante activado fue significativa. RESULTADOS: Se identificaron 10 pacientes en quienes se aplicó factor VII recombinante activado. La causa de hemorragia obstétrica grave fue atonía uterina en seis casos. La dosis promedio de factor VII recombinante activado fue de 91 mcg/kg. En 8 pacientes se administró una dosis y 2 dosis en 2 pacientes. En todas las pacientes se logró la hemostasia; el sangrado disminuyó significativamente posterior a la administración del factor VII recombinante activado (5075 vs 928 mL; p = 0.000) lo mismo que la cantidad de concentrados eritrocitarios trasfundidos (7 vs 3; p = 0.006). Una paciente no requirió histerectomía, otra tuvo tromboembolia pulmonar, que se trató sin problemas y ninguna paciente falleció. CONCLUSIÓN: El factor VII recombinante activado como hemostático en hemorragia obstétrica grave mostró resultados favorables y evitó la histerectomía en una paciente. Requiere vigilancia estrecha de las complicaciones trombóticas.

Abstract OBJECTIVE: To describe outcome of patients with severe obstetric hemorrhage (≥ 1000 mL) treated with rFVIIa as part of the management and to detect complications related to its use. MATERIALS AND METHODS: Retrospective, cross-sectional and descriptive study carried out in patients with severe obstetric hemorrhage treated at the Hospital Civil de Guadalajara Dr. Juan I Menchaca between 2001 and 2017 and treated with activated recombinant factor VII. We identified relevant antecedents, average dose and number of doses of rFVIIa, and hemostatic response. We determined if quantity of bleeding, administration of blood products and hematological parameters before and after using rFVIIa was significantly different. RESULTS: We identified ten patients with rFVIIa administration. The cause of severe obstetric hemorrhage was uterine atony in six cases. The average dose of rFVIIa was 91 mcg/kg; one dose was administered in eight patients and two doses in two patients. Hemostasis was achieved in all patients, bleeding decreased significantly after administration of rFVIIa (5075 mL vs 928 mL, p = 0.000) and the number of erythrocyte concentrates required 7vs 3, p = 0.006). One patient did not require a hysterectomy after rFVIIa administration; one patient presented pulmonary thromboembolism and recovered without complications, no patient died. CONCLUSION: rFVIIa administration as a hemostatic in severe obstetric hemorrhage had favorable results, preventing hysterectomy in one patient. Follow-up requires close monitoring of thrombosis.

Updated concepts on the pathophysiology and the clinical management of trauma hemorrhage and coagulopathy / 中华创伤杂志(英文版)

Uncontrolled hemorrhage and subsequent trauma-induced coagulopathy (TIC) are still the principle causes for preventable death after trauma and early detection and aggressive management have been associated with reduced mortality. Despite increasing knowledge about trauma resuscitation, best practice to treat this newly defined entity is still under debate. A synopsis of best current knowledge with reference to the updated European trauma guideline on the management of severe trauma hemorrhage and TIC is presented. The implementation of evidence-based local protocols and algorithms including clinical quality and safety management systems together with parameters to assess key measures of bleeding control and outcome is advocated.

Postoperative Spinal Epidural Hematoma: The Danger Caused by the Misuse of Thrombin-Containing Local Hemostatics

STUDY DESIGN: Retrospective case-control study. PURPOSE: To examine the hypothesis that the misuse of thrombin-containing local hemostatics (TCLH) increases the risk of postoperative spinal epidural hematoma (POSEH). OVERVIEW OF LITERATURE: Many studies have focused on hypocoagulability as a risk factor for POSEH. However, there are no prior reports on the increased risk of POSEH in hypercoagulable states. METHODS: Posterior instrumented lumbar spine surgery cases over 2 consecutive years were divided into two groups: a study group (98 patients in whom TCLH was used) and a control group (176 patients in whom TCLH was not used). The excess TCLH matrix that was not associated with blood clot was not removed from the patients in the study group. The senior author decided whether to use TCLH or not. Suction drains were used in all patients. The demographics, coagulation-related factors, and intraoperative factors of the patients in the two groups were analyzed. The development of POSEH was compared between the two groups. RESULTS: The two groups were homogenous in demographics (age and sex), coagulation-related factors (platelet count, prothrombin time, activated partial thromboplastin time, and platelet function analysis), and surgical factors (total blood loss, operation time, blood loss/10 minutes, number of fusion segments, posterolateral fusion/posterior lumbar interbody fusion, and virgin or revision surgery). POSEH developed more frequently in the patients in the study group than in those in the control group (14/98 patients, 14.3% vs. 3/176 patients, 1.7%, respectively; p=0.001; odds ratio, 17.1). CONCLUSIONS: TCLH causes blood clot not only at the edge of damaged vessels but also at the site of extravascular blood. Excess TCLH matrix not associated with blood clot at the epidural space can enhance POSEH development because early clotted hematomas do not drain through suction drains.

Efficacy of Oxidized Regenerated Cellulose, SurgiGuard®, in Porcine Surgery

PURPOSE: Adequate hemostasis is important for postoperative outcomes of abdominal surgery. This study evaluated the hemostatic effects and accompanying histopathological changes of a novel oxidized regenerated cellulose, SurgiGuard®, during abdominal surgery. MATERIALS AND METHODS: Ten pigs underwent wedge resection of the spleen (1×1 cm) and liver (1.5×1.5 cm). The resected surface was covered with Surgicel® fabric or fibril type (Group A) or SurgiGuard® fabric or fibril type (Group B). Surgicel® and SurgiGuard® were randomized for attachment to the resected surface by fabric type (n=5) or fibril type (n=5). Blood loss was measured 5, 7, and 9 min after resection. Pigs were necropsied 6 weeks postoperatively to evaluate gross and histopathological changes. RESULTS: There was no significant difference in total blood loss between groups [spleen fabric: Group A vs. Group B, 4.38 g (2.74–6.43) vs. 3.41 g (2.46–4.65), p=0.436; spleen fibril: Group A vs. Group B, 3.44 g (2.82–6.07) vs. 3.60 g (2.03–6.09), p=0.971; liver fabric: Group A vs. Group B, 4.51 g (2.67–10.61) vs. 6.93 g (3.09–9.95), p=0.796; liver fibril: Group A vs. Group B, 3.32 g (2.50–8.78) vs. 3.70 g (2.32–5.84), p=0.971]. Histopathological analysis revealed no significant difference in toxicities related to Surgicel® or SurgiGuard® [inflammation, fibrosis, foreign bodies, and hemorrhage (spleen: p=0.333, 0.127, 0.751, and 1.000; liver: p=0.155, 0.751, 1.000, and 1.000, respectively)]. CONCLUSION: SurgiGuard® is as effective and non-toxic as Surgicel® in achieving hemostasis after porcine abdominal surgery.