Effects of local infiltration of analgesia and tranexamic acid in total knee replacements: safety and efficacy in reducing blood loss and comparability to intra-articular tranexamic acid

INTRODUCTION@#The use of periarticular (PA) tranexamic acid (TXA) and its efficacy in comparison with intra-articular (IA) TXA have not been well explored in the literature. This retrospective cohort study aimed to compare the effects of IA and PA TXA with analgesic components in reducing blood loss and improving immediate postoperative pain relief and functional outcomes in patients after unilateral primary total knee arthroplasty (TKA).@*METHODS@#A total of 63 patients underwent TKA, and they were divided into the IA TXA delivery group ( n = 42) and PA TXA delivery group ( n = 21). All patients were administered 1 g of TXA. They also received pericapsular infiltration consisting of 0.5 mL of adrenaline, 0.4 mL of morphine, 1 g of vancomycin, 1 mL of ketorolac and 15 mL of ropivacaine. Outcomes for blood loss and surrogate markers for immediate functional recovery were measured.@*RESULTS@#Of the 63 patients, 54% were female and 46% male. The mean drop in postoperative haemoglobin levels in the PA and IA groups was 2.0 g/dL and 1.6 g/dL, respectively, and this was not statistically significant ( P = 0.10). The mean haematocrit drop in the PA and IA groups was 6.1% and 5.3%, respectively, and this was also not statistically significant ( P = 0.58). The postoperative day (POD) 1 and discharge day flexion angles, POD 1 and POD 2 visual analogue scale (VAS) scores, gait distance on discharge and length of hospitalisation stay were largely similar in the two groups.@*CONCLUSION@#Our study showed that both IA and PA TXA with analgesic components were equally efficient in reducing blood loss and improving immediate postoperative pain relief and functional outcomes.

Thrombolysis in acute pulmonary embolism

SUMMARY OBJECTIVES Acute pulmonary embolism (APE) is an important cause of cardiovascular mortality, due mainly to hemodynamic instability. In these cases, the recommendation is to perform some reperfusion procedure, with systemic thrombolysis being the main therapy used. However, national data evaluating the efficacy and safety of thrombolysis are scarce. METHODS Retrospective analysis of a case series. We included 13 patients diagnosed with high-risk APE and 4 patients with intermediate-high risk from a single-center, who were treated with alteplase 100mg. RESULTS The mean age of the patients was 55 years, most of them female (76.4%). Among the risk factors for VTE were immobilization (41.17%), contraceptive use (35.29%), cancer (17.63%), and previous history of DVT (11.76%). The most frequent clinical manifestations of APE were dyspnea (88.23%), hypoxia (82.35%), hypotension (82.35%), and tachycardia (64.70%). 82.35% of the patients had echocardiographic signs of right ventricular dysfunction, and 52.94% had increased troponin and BNP. Severe bleeding associated with thrombolysis occurred in 17.54% of cases. No patient died due to bleeding. There were 8 deaths from right ventricular failure (47%), 6 in the cases of patients presenting as high-risk APE (35.3%), and 2 in the cases of intermediate-high risk (11.8%). CONCLUSION Thrombolysis in patients with high-risk APE or intermediate-high risk had a severe bleeding rate of 17.6%. However, the high mortality of this population (47%) due to right ventricular failure justifies the use of this therapeutic modality.

RESUMO OBJETIVOS A embolia pulmonar aguda (EAP) é uma causa importante de mortalidade cardiovascular ao causar instabilidade hemodinâmica. Nesses casos, a recomendação é a realização de algum procedimento de reperfusão, sendo a trombólise sistêmica a principal terapia utilizada. No entanto, dados nacionais avaliando a eficácia e a segurança da trombólise são escassos. MÉTODO Análise retrospectiva de uma série de casos. Foram incluídos 13 pacientes com o diagnóstico de EAP de alto risco e quatro pacientes de risco intermediário-alto, de um único centro, e que foram tratados com alteplase 100 mg. RESULTADOS A média de idade dos pacientes foi 55 anos, sendo a maioria do gênero feminino (76,4%). Dos fatores de risco para TEV, estavam presentes a imobilização (41,17%), o uso de anticonceptivos (35,29%), câncer (17,63%) e história prévia de TVP (11,76%). As manifestações clínicas mais frequentes da EAP foram dispneia (88,23%), hipóxia (82,35%), hipotensão (82,35%) e taquicardia (64,70%); 82,35% dos pacientes apresentaram sinais ecocardiográficos de disfunção ventricular direita e 52,94% apresentaram aumento da troponina e BNP. Sangramento grave associado à trombólise ocorreu em 17,54% dos casos. Nenhum paciente faleceu em decorrência de sangramento. Houve oito mortes por insuficiência ventricular direita (47%): seis nos casos de paciente que se apresentaram como EAP de alto risco (35,3%) e duas nos casos de risco intermediário-alto (11,8%). CONCLUSÃO A trombólise nos pacientes com EAP de alto risco ou risco intermediário-alto apresentou uma taxa de sangramento grave de 17,6%. No entanto, a alta mortalidade dessa população (47%) por insuficiência ventricular direita justifica o uso desta modalidade terapêutica.

Efficacy and safety of antifibrinolytics in oncological surgery: a systematic review and meta-analysis / Eficácia e segurança de antifibrinolíticos em cirurgia oncológica: uma revisão sistemática e metanálise

Abstract Background and objectives: The administration of antifibrinolytics has been shown to be effective in reducing blood loss and the need for transfusions in surgeries. However, few studies have evaluated these drugs in cancer surgery. The objective was to review the efficacy and safety of the treatment with antifibrinolytics in patients who underwent oncologic surgeries. Contents: An electronic bibliographic research was conducted in PubMed, OVID, MEDLINE, EMBASE, EBSCO and in the Cochrane Library data basis in order to identify randomized clinical trials performed in any type of oncologic surgery. The data evaluated were blood loss, need for transfusion and incidence of arteriovenous thromboembolism. Five randomized controlled trials evaluating 838 patients met the inclusion requirements. In the analysis of the incidence of thromboembolic events in the five RCTs, there was no statistically significant difference between the administration of tranexamic acid when compared with the placebo (OR = 0.36, 95% IC: 0.11‒1.19, p= 0.09, I2 = 0%). However, when total estimated blood loss and need for blood transfusion are analyzed, the use of tranexamic acid was associated with a significant reduction over placebo (MD = −135.79, 95% CI: −179.50 to −92.08, p< 0.00001, I2= 68%) and (OR = 0.45, 95% CI: 0.32‒0.65, p< 0.00001, I2= 60%), respectively. Conclusions: This meta-analysis found no evidence that the administration of antifibrinolytics increases the risk of thromboembolic complications in patients submitted to oncologic surgery, and has shown evidence that it is effective in reducing total perioperative blood loss and the need for blood transfusion.

Resumo Justificativa e objetivos: A administração de agentes antifibrinolíticos mostrou ser eficaz para reduzir a perda sanguínea e a necessidade de transfusões em cirurgias. No entanto, poucos estudos avaliaram esses agentes em cirurgias oncológicas. O objetivo foi revisar a eficácia e segurança do tratamento com antifibrinolíticos em pacientes submetidos a cirurgias oncológicas. Conteúdo: Uma pesquisa bibliográfica foi conduzida nos bancos de dados eletrônicos PubMed, OVID, MEDLINE, EMBASE, EBSCO e na Biblioteca Cochrane para identificar ensaios clínicos randomizados feitos em qualquer tipo de cirurgia oncológica. Os dados analisados foram perda sanguínea, necessidade de transfusão e incidência de tromboembolismo arteriovenoso. Cinco ensaios clínicos randomizados que avaliaram 838 pacientes atenderam aos critérios de inclusão. Na análise da incidência de eventos tromboembólicos em cinco ECR, não houve diferença estatisticamente significativa entre a administração do ácido tranexâmico, comparado ao placebo (OR = 0,36, IC 95%: 0,11-1,19, p = 0,09; I2 = 0%). No entanto, quando a perda sanguínea total estimada e a necessidade de transfusão de sangue foram analisadas, o uso do ácido tranexâmico foi associado a uma redução significativa, comparado ao placebo. (DM: -135,79, IC 95%: -179,50 a -92,08, p < 0,00001, I2 = 68%) e (OR = 0,45, IC 95%: 0,32-0,65, p < 0,00001, I2 = 60%), respectivamente. Conclusões: Esta metanálise não encontrou evidências de que a administração de antifibrinolíticos aumente o risco de complicações tromboembólicas em pacientes submetidos à cirurgia oncológica e apresentou evidências de que é eficaz para reduzir a perda sanguínea total no perioperatório e a necessidade de transfusão de sangue.

A randomized prospective analysis of alteration of hemostatic function in patients receiving tranexamic acid and hydroxyethyl starch (130/0.4) undergoing off pump coronary artery bypass surgery.

Postoperative hemorrhagic complications is still one of the major problems in cardiac surgeries. It may be caused by surgical issues, coagulopathy caused by the side effects of the intravenous fluids administered to produce plasma volume expansion such as hydroxyl ethyl starch (HES). In order to thwart this hemorrhagic issue, few agents are available. Fibrinolytic inhibitors like tranexamic acid (TA) may be effective modes to promote blood conservation; but the possible complications of thrombosis of coronary artery graft, precludes their generous use in coronary artery bypass graft surgery. The issue is a balance between agents that promote coagulation and those which oppose it. Therefore, in this study we have assessed the effects of concomitant use of HES and TA. Thromboelastogram (TEG) was used to assess the effect of the combination of HES and TA. With ethical committee approval and patient's consent, 100 consecutive patients were recruited for the study. Surgical and anesthetic techniques were standardized. Patients fulfilling our inclusion criteria were randomly allocated into 4 groups of 25 each. The patients in group A received 20 ml/kg of HES (130/0.4), 10 mg/kg of T.A over 30 minutes followed by infusion of 1 mg/kg/hr over the next 12 hrs. The patients in group B received Ringer's lactate + TA at same dose. The patients in the Group C received 20 ml/kg of HES. Group D patients received RL. Fluid therapy was goal directed. Total blood loss was assessed. Reaction time (r), α angle, maximum amplitude (MA) values of TEG were assessed at baseline, 12, 36 hrs. The possible perioperative myocardial infraction (MI) was assessed by electrocardiogram (ECG) and troponin T values at the baseline, postoperative day 1. Duration on ventilator, length of stay (LOS) in the intensive care unit (ICU) were also assessed. The demographical profile was similar among the groups. Use of HES increased blood loss significantly (P < 0.05). Concomitant use of TA reduced blood loss when used along with HES. r value was prolonged at 12 hours in all the groups and α angle was reduced at 12 hours in all the groups, where as MA value was reduced at 12 th hour in the HES group compared to the baseline and increased in TA + HES group. These findings were statistically significant. No significant change in Troponin T values/ ECG, duration of ventilation and LOS ICU was observed. No adverse events was noticed in any of the four groups. HES (130/0.4) used at a dose of 20 ml/kg seems to produce coagulopathy causing increased blood loss perioperatively. Hemodilution produced by fluid therapy seems to produce Coagulopathy as observed by TEG parameters. Concomitant use of TA with HES appears to reverse these changes without causing any adverse effects in patients undergoing OPCAB surgery.

Introduction of pharmacovigilance in a new university hospital in Morocco: how and why

In an effort to improve patient safety, Hassan II hospital in Fez introduced a pharmacovigilance system for notification of adverse drug reactions as a priority objective. The implementation of pharmacovigilance activities actually began in June 2007 but it was in 2009 after the inauguration of the new complex that the system became properly operational. This report outlines the activities carried out to develop and implement this system, including informing and training the health professionals, and the results obtained after its introduction. From 2007 to 2009, fewer than 100 cases of adverse drug reactions were reported. Up to June 2011, however, 520 reports of adverse drug reactions were recorded. The classes of drugs most implicated in adverse events were: cancer drugs [26%], anti-inflammatory drugs and antibiotics [each 15%], analgesics [12%], iodinated contrast agents [6%], and anticoagulants and corticosteroids [5%]. The main adverse events were dermatological and 27% of reports came from the internal medicine department, followed by hepatogastroenterology [25%]. Of the 520 cases reported, 46% were severe

Risk factors associated with postoperative seizures in patients undergoing cardiac surgery who received tranexamic acid: A case-control study.

Antifibrinolytic agents are used during cardiac surgery to minimize bleeding and reduce exposure to blood products. Several reports suggest that tranexamic acid (TA) can induce seizure activity in the postoperative period. To examine factors associated with postoperative seizures in patients undergoing cardiac surgery who received TA. University-affiliated hospital. Case-control study. Patients undergoing cardiac surgery with cardiopulmonary bypass (CPB) between January 2008 and December 2009 were identified. During this time, all patients undergoing heart surgery with CPB received TA. Cases were defined as patients who developed seizures that required initiation of anticonvulsive therapy within 48 h of surgery. Exclusion criteria included subjects with preexisting epilepsy and patients in whom the convulsive episode was secondary to a new ischemic lesion on brain imaging. Controls who did not develop seizures were randomly selected from the initial cohort. From an initial cohort of 903 patients, we identified 32 patients with postoperative seizures. Four patients were excluded. Twenty-eight cases and 112 controls were analyzed. Cases were more likely to have a history of renal impairment and higher preoperative creatinine values compared with controls (1.39 ± 1.1 vs. 0.98 ± 0.02 mg/dL, P = 0.02). Significant differences in the intensive care unit, postoperative and total lengths of stay were observed. An association between high preoperative creatinine value and postoperative seizure was identified. TA may be associated with the development of postoperative seizures in patients with renal dysfunction. Doses of TA should be reduced or even avoided in this population.

Uso tópico de agente antifibrinolítico na redução do sangramento após revascularização cirúrgica do miocárdio / Topical use of antifibrinolytic agent to reduce postoperative bleeding after coronary artery bypass surgery

OBJETIVO: Verificar o efeito do uso tópico do ácido epsilon-aminocapróico (AEAC), aplicado na cavidade pericárdica, na redução do sangramento e necessidade de transfusão sanguínea no pós-operatório de revascularização cirúrgica do miocárdio. MÉTODOS: Entre outubro de 2007 e outubro de 2008, 53 pacientes da mesma instituição foram alocados em um estudo prospectivo, randomizado e duplo-cego. Foram selecionados portadores de insuficiência coronariana crônica com indicação para revascularização cirúrgica do miocárdio. Os pacientes foram divididos em dois grupos: grupo AEAC e grupo Placebo, comparados de acordo com as características clínicas, demográficas e variáveis operatórias. Foram avaliados o volume de sangramento pelos drenos, a necessidade de transfusão e os níveis de hemoglobina e hematócrito de pós-operatório. RESULTADOS: O sangramento pós-operatório pelos drenos nas primeiras 24 horas (grupo AEAC 154,66±74,64 x grupo placebo 220,21±136,42 ml; P=0,031) foi menor no grupo AEAC, porém, em 48 horas (grupo AEAC 259,14±420,07 x grupo placebo 141,67±142,58 ml; P=0,197) e a perda acumulada até a retirada dos drenos (grupo AEAC 832,07±576,86 x grupo placebo 827,50±434,12 ml; P=0,975) não apresentou diferença estatística significante. Houve menor necessidade de transfusão no grupo AEAC, com diferença estatística significante (grupo AEAC 185,90±342,07 x grupo placebo 439,42±349,07 ml; P=0,016). Os valores de hemoglobina (grupo AEAC 9,18±0,92 x grupo placebo 8,85±1,48 g/dL; P=0,331) e hematócrito (grupo AEAC 28,15±3,35 x grupo placebo 26,67±4,15 por cento; P=0,162) não mostraram diferença estatística significante na comparação entre os grupos. CONCLUSÕES: O uso tópico do ácido epsilon-aminocapróico apresentou efeito favorável na redução do sangramento nas primeiras 24 horas de pós-operatório e na necessidade de transfusão sanguínea após revascularização cirúrgica do miocárdio. Trabalhos adicionais com maior número de pacientes serão necessários ...

OBJECTIVE: Antifibrinolytic agents reduce bleeding after cardiac surgery, but there are adverse effects after their systemic use. These effects are avoided by topical application of antifibrinolytic agents in pericardial cavity. We compared the effects of topically applied epsilon-aminocaproic acid (EACA) and placebo on postoperative bleeding and transfusion requirements after coronary artery bypass surgery. METHODS: In this single center prospective, randomized, double-blind trial, 53 patients were randomized into two groups to receive EACA (24 g in 250 ml of saline solution) or placebo (250 ml of saline solution) before sternal closure. Groups were comparable with respect to all preoperative and intraoperative variables. Postoperative bleeding, transfusion requirements and hematologic parameters were evaluated. RESULTS: Postoperative bleeding within first 24 hours (h) period (EACA group 154.66±74.64 x Placebo group 220.21±136.42 ml; P=0.031) showed statistically significant inter-group difference, within 48 h (EACA group 259.14±420.07 x Placebo group 141.67±142.58 ml; P=0.614), as well as cumulative blood loss (EACA group 832.07±576.86 x Placebo group 827.50±434.12 ml; P=0.975), not showed statistically inter-group differences. Inter-group difference of blood product requirements was statistically significant (EACA group 185.90±342.07 x Placebo group 439.42±349.07 ml; P=0.016). Laboratory analyses showed no differences between the two groups postoperative (hematologic characteristics: hemoglobin (g/dl)- EACA group 9.18±0.92 x Placebo group 8.85±1.48 g/dL; P=0.11; hematocrit ( percent)-EACA group 28.15±3.35 x Placebo group 26.67±4.15 percent; P=0.06). CONCLUSION: Topical use of epsilon aminocaproic acid reduces postoperative bleeding in the first 24 hours and requirements of blood transfusion after coronary artery bypass graft surgery

Successful outcome after evacuation of intracranial hematoma following thrombolysis in acute myocardial infarction

Thrombolytic therapy is the modality of choice for the treatment of life threatening thrombosis in various vascular territories and nowadays, is used extensively in setting of acute myocardial infarction. There is, however, the omnipresent danger of serious bleeding inherently associated with the use of all thrombolytics which if it occurs in the brain, can lead to potentially serious neurological impairment and even death. In our report, we describe the successful surgical management of a streptokinase-induced intracranial hemorrhage. Timely neurosurgical intervention is advocated as the optimal approach for this particular side effect of thrombolytic agents