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2.
Ther Adv Cardiovasc Dis ; 14: 1753944720924255, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32449469

RESUMO

BACKGROUND: Recombinant factor VIIa (rFVIIa) (Novoseven®) is utilized for the reversal of anticoagulation-associated bleeding and refractory bleeding in cardiac surgery. In August 2015, rFVIIa was transferred from the blood bank to the pharmacy at New York University (NYU) Langone Health. Concordantly, an off-label dosing guideline was developed. The objective of this study was to describe utilization and cost of rFVIIa and assess compliance to our dosing guideline. METHODS: We performed a retrospective, observational review of rFVIIa administrations post-implementation of an off-label dosing guideline. All patients who received rFVIIa between September 2015 and June 2017 were evaluated. For each rFVIIa administration, anticoagulation and laboratory values, indications for use, dosing, ordering and administration times, concomitant blood products, and adverse events were collected. Adverse events included venous thromboembolism, stroke, myocardial infarction, and death due to systemic embolism and mortality. The primary endpoint was the utilization of rFVIIa in accordance with the off-label dosing guideline. Secondary endpoints included hemostatic efficacy of rFVIIa, adverse events, blood products administered, and cost-effectiveness of rFVIIa transition to pharmacy. RESULTS: A total of 63 patients [pediatric (n = 6), adult (n = 57)] received rFVIIa, with the majority of use for refractory bleeding after cardiac surgery. The utilization of rVIIa decreased after development of the off-label dosing guideline and transition from blood bank to pharmacy. The total incidence of thromboembolic events within 30 days was 19.6%; 17.6% arterial and 2% venous; 70% of patients with an adverse event were over 70 years of age. Use of rFVIIa reduced the median number of units of blood products administered. CONCLUSION: Administration of rFVIIa for cardiac surgery appears to be effective for hemostasis. Transitioning rFVIIa from the blood bank to pharmacy and implementation of a dosing guideline appears to have reduced utilization. Patients receiving rFVIIa should be monitored for thromboembolic events. Elderly patients may be at higher risk for thromboembolic events.


Assuntos
Centros Médicos Acadêmicos , Anticoagulantes/efeitos adversos , Perda Sanguínea Cirúrgica/prevenção & controle , Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Fator VIIa/administração & dosagem , Hemorragia/prevenção & controle , Hemostáticos/administração & dosagem , Padrões de Prática Médica , Centros Médicos Acadêmicos/economia , Idoso , Procedimentos Cirúrgicos Cardíacos/economia , Criança , Pré-Escolar , Custos de Medicamentos , Cálculos da Dosagem de Medicamento , Revisão de Uso de Medicamentos , Fator VIIa/efeitos adversos , Fator VIIa/economia , Feminino , Hemorragia/induzido quimicamente , Hemorragia/economia , Hemostáticos/efeitos adversos , Hemostáticos/economia , Humanos , Lactente , Recém-Nascido , Masculino , Pessoa de Meia-Idade , Cidade de Nova Iorque , Uso Off-Label , Padrões de Prática Médica/economia , Proteínas Recombinantes/administração & dosagem , Proteínas Recombinantes/efeitos adversos , Proteínas Recombinantes/economia , Estudos Retrospectivos , Fatores de Risco , Tromboembolia/induzido quimicamente , Resultado do Tratamento
3.
Obstet Gynecol ; 135(2): 463-468, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31923069

RESUMO

Since a variety of procoagulant products, collectively called hemostatic agents, became available to surgeons in the mid-20th century, their use has increased across multiple specialties, including gynecology. Congruent with past research on the causes of regional variation in the practice of medicine, available evidence suggests that a central predictor for use of these products is physician preference rather than documented clinical necessity. Use of these products adds risks and avoidable cost. This article seeks to highlight specific gynecologic circumstances in which evidence and surgical judgment supports hemostatic agent use and other settings in which use should be reconsidered.


Assuntos
Adesivo Tecidual de Fibrina/uso terapêutico , Procedimentos Cirúrgicos em Ginecologia , Hemostáticos/uso terapêutico , Procedimentos Cirúrgicos Minimamente Invasivos , Administração Tópica , Perda Sanguínea Cirúrgica , Feminino , Adesivo Tecidual de Fibrina/efeitos adversos , Adesivo Tecidual de Fibrina/economia , Hemostáticos/efeitos adversos , Hemostáticos/economia , Humanos , Duração da Cirurgia , Medição de Risco
4.
Blood Coagul Fibrinolysis ; 30(8): 385-392, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31738288

RESUMO

: The novel agent pd-FVIIa/FX is a 1 : 10 protein weight mixture of activated factor VII (FVIIa) and factor X (FX) derived from donated blood plasma. A phase III clinical trial of pd-FVIIa/FX revealed high efficacy for bleeding episodes in haemophilia patients with inhibitors. However, up to now, only one case of this new agent being used for surgery had been reported. The objective of this study is to evaluate the perioperative haemostatic efficacy and safety of pd-FVIIa/FX in haemophilia patients with inhibitors. We retrospectively reviewed 25 operation charts from 14 haemophilia patients with high-responding inhibitors using pd-FVIIa/FX during the perioperative period. Efficacy was evaluated by attending physicians and results divided into four groups (excellent, good, fair, and poor). The operation chart was provided by nine Japanese medical institutes with expertise in haemophilia management. Out of the total of 25 surgical procedures, 44% (11/25) were classified as major surgery and the remainders were minor surgeries. In all of the surgeries but one, rFVIIa and/or APCC were administered in combination or sequential method. In all cases except one, the haemostatic efficiency rate was judged as excellent or good by treating physicians for an overall efficacy rate of 96%. No thrombotic adverse effects were reported. This study's results suggest that both combination and sequential therapy of pd-FVIIa/FX and other bypassing agents are well tolerated and effective for the control of perioperative bleeding in haemophilia patients with high-responding inhibitors.


Assuntos
Fator VIIa/uso terapêutico , Fator X/uso terapêutico , Hemofilia A/tratamento farmacológico , Hemofilia B/tratamento farmacológico , Hemostáticos/normas , Assistência Perioperatória/métodos , Adulto , Combinação de Medicamentos , Quimioterapia Combinada/efeitos adversos , Fator VIIa/efeitos adversos , Fator X/efeitos adversos , Hemofilia A/imunologia , Hemofilia B/imunologia , Hemorragia/prevenção & controle , Hemostáticos/efeitos adversos , Hemostáticos/uso terapêutico , Humanos , Masculino , Assistência Perioperatória/efeitos adversos , Estudos Retrospectivos , Procedimentos Cirúrgicos Operatórios/efeitos adversos , Procedimentos Cirúrgicos Operatórios/métodos , Procedimentos Cirúrgicos Operatórios/normas , Trombose/induzido quimicamente , Resultado do Tratamento , Adulto Jovem
5.
Am J Case Rep ; 20: 1497-1499, 2019 Oct 11.
Artigo em Inglês | MEDLINE | ID: mdl-31601777

RESUMO

BACKGROUND Radiofrequency ablation is a minimally invasive treatment for arrhythmias, including frequent ventricular premature. As a complication of radiofrequency ablation, pseudoaneurysm can be treated conservatively or by ultrasound-guided thrombin injection. CASE REPORT We report a case that a possible allergic reaction to thrombin injected into pseudoaneurysm after radiofrequency ablation. CONCLUSIONS We hope that the report of successful management of the allergic reaction in this case may be of help to other doctors; we also emphasize the importance of checking the patient's history of allergies to thrombin when considering treating pseudoaneurysm with thrombin injection.


Assuntos
Falso Aneurisma/terapia , Hipersensibilidade a Drogas/diagnóstico , Artéria Femoral , Hemostáticos/efeitos adversos , Trombina/efeitos adversos , Idoso de 80 Anos ou mais , Alanina Transaminase/sangue , Hipersensibilidade a Drogas/etiologia , Eletrocardiografia , Feminino , Febre/etiologia , Fibrina/análise , Produtos de Degradação da Fibrina e do Fibrinogênio/análise , Hemoglobinas/análise , Hemostáticos/administração & dosagem , Humanos , Hipotensão/etiologia , Injeções Intra-Arteriais , Leucopenia/etiologia , Náusea/etiologia , Ablação por Radiofrequência , Trombina/administração & dosagem , Trombocitopenia/etiologia , Complexos Ventriculares Prematuros/cirurgia
6.
PLoS Med ; 16(10): e1002930, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31634354

RESUMO

BACKGROUND: Desmopressin was approved by the Food and Drug Administration (FDA) in 1978 for use in diabetes insipidus and bleeding disorders, but it is also prescribed off-label for patients with nocturia. Quantifying the potential risks facing adult patients taking desmopressin has taken on added importance because a new intranasal formulation of desmopressin was approved by the FDA in 2017. Like the old formulation, the main active ingredient is desmopressin acetate, but the new formulation also contains an excipient designed to enhance absorption. Our objective was to quantify the rate of hyponatremia in routine clinical care for patients prescribed the older formulation of desmopressin. METHODS AND FINDINGS: We conducted a population-based new-user cohort study from 1 February 2006 to 1 February 2017 using a nationwide commercial health plan database. Patients newly prescribed the older formulation of desmopressin were propensity-score (PS)-matched to patients newly prescribed oxybutynin. As a sensitivity analysis, tamsulosin was used as the comparator rather than oxybutynin. The primary outcome was a primary position diagnosis of hyponatremia. Proportional hazard models after 1:1 PS matching were used to estimate hazard ratios (HRs) and 95% confidence intervals (CI). We identified 3,137 adults who were newly prescribed desmopressin and matched them to 3,137 adults who were newly prescribed oxybutynin. Mean age was 70, 55% were male, 13% filled a prescription for a diuretic during the baseline time period, and the mean baseline sodium prior to receiving either study drug was 140 mmol/L (normal: 135-145). The rate of hyponatremia was 146 per 1,000 person-years for adults prescribed desmopressin compared to 11 per 1,000 person-years for adults prescribed oxybutynin, corresponding to a 13-fold higher rate (HR 13.19; 95% CI 6.69, 26.01; p < 0.01). When follow-up was truncated at 30 days, a similar increased rate was observed (HR 19.41; 95% CI 7.11, 52.99; p < 0.01). A higher rate of hyponatremia was also observed with desmopressin when tamsulosin was the comparator (HR 12.10; 95% CI 6.54, 22.37; p < 0.01). Important limitations of our study include unmeasured confounding (for example, over-the-counter medication use, dietary intake), missing data (i.e., only 20% of patients had a baseline serum sodium), and a lack of data on the newer formulation of desmopressin. CONCLUSIONS: Use of an older formulation of desmopressin was associated with a marked increased rate of subsequent hyponatremia compared to use of other medications indicated for lower urinary tract symptoms. Such risks should be clearly communicated to patients prescribed this formulation of desmopressin.


Assuntos
Desamino Arginina Vasopressina/efeitos adversos , Hemostáticos/efeitos adversos , Hiponatremia/induzido quimicamente , Administração Intranasal , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Feminino , Humanos , Masculino , Ácidos Mandélicos/administração & dosagem , Pessoa de Meia-Idade , Noctúria/tratamento farmacológico , Pontuação de Propensão , Modelos de Riscos Proporcionais , Fatores de Risco , Tansulosina/administração & dosagem , Resultado do Tratamento
7.
Int J Hematol ; 110(6): 743-750, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31559563

RESUMO

Optimal supportive care for disseminated intravascular coagulation (DIC) and hemostatic complications by asparaginase is indispensable for the successful treatment of pediatric leukemia. However, the situation regarding this type of care in Japan is unclear. We conducted a questionnaire-based survey at 155 institutions treating childhood leukemia in Japan. The questionnaire asked about the supportive care provided by each institution to acute leukemia patients with DIC and asparaginase-induced hemostatic alterations. Ninety-eight institutions responded. The most common diagnostic criteria for DIC were those established by the Japanese Ministry of Health and Welfare. Regardless of the etiology underlying DIC, recombinant human thrombomodulin and synthetic protease inhibitors were used as anticoagulation therapy by around 70% and 40% of institutions, respectively. Additionally, 92%, 93%, and 73% of institutions measured plasma antithrombin, fibrinogen, and D-dimer/fibrin degradation products, respectively, more than twice per week during induction therapy for acute lymphoblastic leukemia. Survey responses indicate that 95% and 24% of the institutions used antithrombin replacement and fresh-frozen plasma, respectively. Supportive care for DIC and/or asparaginase-induced hemostatic alterations at Japanese pediatric centers was intensive and differs markedly from protocols in other countries. The efficacy of supportive care should be evaluated prospectively in the setting of pediatric leukemia.


Assuntos
Hemostáticos/efeitos adversos , Leucemia/complicações , Cuidados Paliativos/métodos , Anticoagulantes , Asparaginase/efeitos adversos , Criança , Coagulação Intravascular Disseminada/etiologia , Coagulação Intravascular Disseminada/terapia , Humanos , Japão , Leucemia/tratamento farmacológico , Pediatria , Inibidores de Proteases/uso terapêutico , Inquéritos e Questionários , Trombomodulina/uso terapêutico
9.
Carbohydr Polym ; 216: 213-216, 2019 Jul 15.
Artigo em Inglês | MEDLINE | ID: mdl-31047059

RESUMO

Oxidized regenerated cellulose has become a major local surgical hemostatic biomaterial because of its ease of use, favorable biocompatibility, bactericidal activity and bioabsorption characteristics. Additional clinical indications of oxidized regenerated cellulose include wound repair and tissue reconstruction. Sometimes, some unusual adverse events are described. Studies report cases of minor postoperative complications as nidus of infection or allergic reaction mainly presenting as acute dermatitis, eczema and sieroma. Also, rare and serious cases of foreign body reaction or impingement on nerve, due to not optimal bioabsorption, are showed in various surgical sites. Thus, on the one hand, patients should be informed by their clinicians of the possibility of these low incidence postoperative complications when considering preparations made of cellulose derivatives; and the clinicians should clearly indicate use of this biomaterial in the surgical procedure report so that radiologists may appropriately interpret any unusual findings potentially associated with this biomaterial use and thus avoid misdiagnosis and undue alarm in the follow-up of patients. On the other hand, the biomedical carbohydrate scientist must consider effective experimental design that substantially addresses the clinical adverse events associated with carbohydrate polymer use. Optimal development of carbohydrates for clinical use depends on excellent clinician/biomedical scientist communication.


Assuntos
Plásticos Biodegradáveis/efeitos adversos , Celulose Oxidada/efeitos adversos , Complicações Pós-Operatórias/induzido quimicamente , Quitosana/efeitos adversos , Hemostáticos/efeitos adversos , Humanos , Hipersensibilidade , Tecidos Suporte/efeitos adversos
10.
Int Urol Nephrol ; 51(6): 995-1004, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31028561

RESUMO

BACKGROUND: Desmopressin is used to reduce bleeding complications for kidney biopsies with azotemia but little is known about desmopressin-induced hyponatremia in these individuals. We aimed to evaluate the impact of desmopressin prophylaxis on severe hyponatremia and bleeding after kidney biopsies in individuals with renal impairment. METHOD: This is a single-center retrospective cohort study of consecutive adults with serum creatinine ≥ 150 µmol/L and had ultrasound-guided percutaneous native or transplant kidney biopsies between June 2011 and July 2015. Data were retrieved from electronic medical records. Primary outcomes were the use of desmopressin prophylaxis and severe hyponatremia (serum sodium ≤ 125 mmol/L) within 7 days post-biopsy. Secondary outcome was post-biopsy bleeding. RESULTS: 240 native kidney and 196 allograft biopsies were performed. Median age was 51 (IQR 42.3, 60) years and eGFR was 21.9 (12.9, 30.1) ml/min/1.73 m2. Although patients prescribed desmopressin prophylaxis (n = 226) had higher serum creatinine [279 (201, 392) vs. 187 (160, 241), p < 0.001], bleeding (15.0% vs. 13.3%, p = 0.60) was not significantly different with and without desmopressin. Severe hyponatremia occurred in 30 biopsies (6.9%) with nadir serum sodium level of 122 (119, 124) mmol/L at 3 (2, 5) days after biopsy, more frequently among those with desmopressin prophylaxis (10.7% vs. 3.0%, p = 0.002). Multi-variate analysis found that pre-biopsy serum sodium level [adjusted OR 0.80 (95% CI 0.72, 0.90), p < 0.001] and desmopressin prophylaxis [adjusted OR 4.02 (95% CI 1.58, 10.21), p = 0.003] were independently associated with severe hyponatremia after kidney biopsy. CONCLUSION: Pre-biopsy desmopressin was associated with severe hyponatremia in individuals with renal impairment; hence, susceptible patients given desmopressin should be closely monitored.


Assuntos
Desamino Arginina Vasopressina/uso terapêutico , Hemostáticos/uso terapêutico , Hiponatremia/induzido quimicamente , Rim/patologia , Hemorragia Pós-Operatória/prevenção & controle , Biópsia/métodos , Estudos de Coortes , Desamino Arginina Vasopressina/efeitos adversos , Feminino , Hemostáticos/efeitos adversos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Resultado do Tratamento
11.
J Surg Res ; 239: 269-277, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-30884383

RESUMO

BACKGROUND: A novel injectable expanding foam based on hydrophobically modified chitosan (HM-CS) was developed to improve hemostasis during surgeries. HM-CS is an amphiphilic derivative of the natural biopolymer chitosan (CS); HM-CS has been shown to improve the natural hemostatic characteristics of CS, but its internal safety has not been systematically evaluated. The goal of this study was to compare the long-term in vivo safety of HM-CS relative to a commonly used fibrin sealant (FS), TISSEEL (Baxter). METHODS: Sixty-four Sprague-Dawley rats (275-325 g obtained from Charles River Laboratories) were randomly assigned to control (n = 16) or experimental (n = 48) groups. Samples of the test materials (HM-CS [n = 16], CS [n = 16], and FS [n = 16]) applied to a nonlethal liver excision (0.4 ± 0.3 g of the medial lobe) in rats were left inside the abdomen to degrade. Animals were observed daily for signs of morbidity and mortality. Surviving animals were sacrificed at 1 and 6 wk; the explanted injury sites were microscopically assessed. RESULTS: All animals (64/64) survived both the 1- and 6-wk time points without signs of morbidity. Histological examination showed a comparable pattern of degradation for the various test materials. FS remnants and significant adhesions to neighboring tissues were observed at 6 wk. Residual CS and HM-CS were observed at the 6 wk with fatty deposits at the site of injury. Minimal adhesions were observed for CS and HM-CS. CONCLUSIONS: The internal safety observed in the HM-CS test group after abdominal implantation indicates that injectable HM-CS expanding foam may be an appropriate internal use hemostatic candidate.


Assuntos
Perda Sanguínea Cirúrgica/prevenção & controle , Quitosana/administração & dosagem , Hemostasia Cirúrgica/métodos , Hemostáticos/administração & dosagem , Animais , Quitosana/efeitos adversos , Quitosana/química , Modelos Animais de Doenças , Adesivo Tecidual de Fibrina/administração & dosagem , Hemostáticos/efeitos adversos , Hemostáticos/química , Humanos , Interações Hidrofóbicas e Hidrofílicas , Fígado/cirurgia , Masculino , Camundongos , Ratos , Ratos Sprague-Dawley
13.
Surg Endosc ; 33(7): 2349-2356, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-30820658

RESUMO

INTRODUCTION: Hemostatic powder (TC-325) is a new tool for treatment of gastrointestinal bleeding that allows the treatment of large surfaces with active bleeding. The aim was to describe the initial success of TC-325 for the control of GI bleeding. MATERIALS AND METHODS: We did a multicenter cohort study with patients admitted to the endoscopy service for GI bleeding. A format was generated to standardize the information obtained in each center. It was determined whether this treatment had been used as a single therapy or as a combination therapy. Descriptive statistics with medians and ranges, or averages with SD according to distribution. RESULTS: Eighty-one patients with 104 endoscopic procedures were included. The median number of endoscopic procedures was 1 (1-3). In the first procedure, the initial success rate was 98.8% (n = 80), failure rate was 1.2% (n = 1), and rebleeding rate was 20% (n = 16). The majority of rebleeding cases occurred within the first 3 days (12/16, 75%). There was no association between rebleeding and etiology (malignant or benign; P = 0.6). In first procedure, 44 (54%) cases had monotherapy with TC-325 and 37 (46%) cases had a combined endoscopic therapy. There were no differences in initial success or rebleeding rates when TC-325 was used as monotherapy versus combined therapy (P = 0.7). The mortality rate was 4% (3/81). CONCLUSION: TC-325 is effective for achieving initial control of bleeding in patients with different GI etiologies. The rate of bleeding recurrence is considerable in both patients with benign and malignant etiology.


Assuntos
Hemorragia Gastrointestinal/terapia , Hemostase Endoscópica/métodos , Hemostáticos/uso terapêutico , Minerais/uso terapêutico , Adulto , Idoso , Idoso de 80 Anos ou mais , Terapia Combinada , Feminino , Hemorragia Gastrointestinal/etiologia , Hemostase Endoscópica/efeitos adversos , Hemostáticos/efeitos adversos , Humanos , Masculino , Pessoa de Meia-Idade , Minerais/efeitos adversos , Recidiva , Estudos Retrospectivos
14.
Niger J Clin Pract ; 22(3): 416-421, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30837433

RESUMO

Introduction: Inhibitor formation is a major complication of hemophilia treatment because it interferes with the clinical response to factor replacement and causes significant morbidity. This cross-sectional study was conducted to assess the presence and frequency of inhibitors among registered person with hemophilia and to identify risk factors associated with inhibitor development. Patients and Methods: A total of 143 hemophilics, 118 with hemophilia A (HA) and 25 with hemophilia B (HB), were enrolled for the study. Participant's clinical data were obtained through patient's medical records. Factor VIII and IX levels and the presence of inhibitors were assessed using a fully automated coagulometer. From the results of a Bethesda assay, patients were divided into those with high titers (≥5 BU) and those with low titers (<5 BU). Results: The patient's age ranged from 1 to 67 years with median of 13.8 years. Inhibitors were detected in 18.6% and none of HA and HB patients, respectively. Of the 22 patients with HA and inhibitors, 18 (82%) had high titer inhibitors. The frequency of inhibitors was significantly higher among patients with severe hemophilia, a history of early exposure (≤3 months) to factor VIII concentrate, and family histories of autoimmune disease and immune system challenges (P < 0.05). The independent risk factors associated with inhibitor development were severe hemophilia (95% CIs = 1.02-55.6, OR = 7.5) and immune system challenges (95% CIs = 1.14-5.99, OR = 2.6). Conclusion: Inhibitors were common among HA patients, and both severe HA and immune system challenges (surgery and trauma) are independent risk factors for inhibitor development.


Assuntos
Fator IXa/antagonistas & inibidores , Fator VIII/antagonistas & inibidores , Hemofilia A/sangue , Hemofilia B/sangue , Adolescente , Adulto , Idoso , Criança , Pré-Escolar , Estudos Transversais , Fator IXa/metabolismo , Fator IXa/uso terapêutico , Fator VIII/metabolismo , Fator VIII/uso terapêutico , Hemofilia A/tratamento farmacológico , Hemofilia B/tratamento farmacológico , Hemostáticos/efeitos adversos , Hemostáticos/uso terapêutico , Humanos , Lactente , Iraque , Pessoa de Meia-Idade , Fatores de Risco , Adulto Jovem
15.
Surg Infect (Larchmt) ; 20(5): 378-381, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-30785856

RESUMO

Background: We describe the management and control of an outbreak of mediastinitis in a cardiac surgery department. Method: We performed a retrospective cohort study of 87 patients who underwent coronary artery bypass grafting (CABG), valve replacement, or both during a five-month period with a higher than normal number of cases of post-operative mediastinitis. In addition to medical records review, a survey was conducted among surgeons to estimate the frequency of cellulose-derived absorbable hemostatic (CDAH) use. Results: Eleven patients (12.5%) developed mediastinitis during the period. None of them died, and the course of the infections was benign. No differences were found between the infected and non-infected patients regarding clinical or demographic characteristics. The rate of infection by surgeon ranged from 0 to 21.4%. (p = 0.38). We found a significant linear relation between the frequency of CDAH use and the risk of infection, from 3.3% to 22.6% (p = 0.024). Cultures of unused CDAHs were negative. Cessation of product use led to no new cases for the following year and to a mediastinitis rate <1% for the following 24 months. Conclusion: We identified a cluster of undesired clinical outcomes compatible with mediastinitis that added morbidity and associated cost, but not deaths, related to the use of CDAH as a hemostatic. These data suggest keeping the use of CDAH in cardiothoracic surgery to a minimum.


Assuntos
Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Celulose/efeitos adversos , Surtos de Doenças , Hemostasia Cirúrgica/efeitos adversos , Hemostáticos/efeitos adversos , Mediastinite/epidemiologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Procedimentos Cirúrgicos Cardíacos/métodos , Celulose/administração & dosagem , Feminino , Hemostasia Cirúrgica/métodos , Hemostáticos/administração & dosagem , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Fatores de Risco
16.
Asian Cardiovasc Thorac Ann ; 27(1): 42-44, 2019 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-30789010

RESUMO

In cardiac surgery, supplementation with recombinant factor VIIa is the treatment of choice for patients with factor VII deficiency, but overzealous administration can be associated with thromboembolic side-effects. A 53-year-old man with factor VII activity 15.2%, international normalized ratio 2.9, and acute thrombotic critical coronary anatomy, underwent coronary artery bypass surgery and a thoracotomy with decortication 5 months later. He was managed successfully without recombinant factor VIIa supplementation. This case demonstrates that current bedside and laboratory tests such as thromboelastography, prothrombin time or international normalized ratio, and factor VII activity may not predict replacement therapy in these patients.


Assuntos
Coagulação Sanguínea/efeitos dos fármacos , Ponte de Artéria Coronária , Doença das Coronárias/cirurgia , Deficiência do Fator VII/tratamento farmacológico , Fator VIIa/administração & dosagem , Hemostáticos/administração & dosagem , Espondilite Anquilosante/cirurgia , Toracotomia , Tomada de Decisão Clínica , Ponte de Artéria Coronária/efeitos adversos , Doença das Coronárias/complicações , Doença das Coronárias/diagnóstico , Esquema de Medicação , Monitoramento de Medicamentos/métodos , Deficiência do Fator VII/sangue , Deficiência do Fator VII/complicações , Deficiência do Fator VII/diagnóstico , Fator VIIa/efeitos adversos , Hemostáticos/efeitos adversos , Humanos , Coeficiente Internacional Normatizado , Masculino , Pessoa de Meia-Idade , Seleção de Pacientes , Valor Preditivo dos Testes , Proteínas Recombinantes/administração & dosagem , Proteínas Recombinantes/efeitos adversos , Espondilite Anquilosante/complicações , Espondilite Anquilosante/diagnóstico , Toracotomia/efeitos adversos , Tromboelastografia , Resultado do Tratamento
17.
J Thromb Haemost ; 17(4): 657-665, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-30762945

RESUMO

Essentials Strategies to improve platelet function may reduce excessive bleeding during cardiac surgery. Patients were randomized to standard care or standard care + noradrenaline infusion. Low-dose noradrenaline improved intraoperative platelet aggregation and clot formation. Noradrenaline may be considered to improve intraoperative hemostasis during cardiac surgery. SUMMARY: Background New approaches to prevent bleeding complications during cardiac surgery are needed. Objective To investigate if noradrenaline (NA) enhances platelet aggregation in patients undergoing coronary artery bypass grafting (CABG). Patients/Methods Twenty-four patients undergoing coronary artery bypass grafting (CABG) were included in a prospective parallel-group randomized study. All patients but one were treated with acetylsalicylic acid (ASA). In the treatment group (n = 12), mean arterial blood pressure (MAP) was maintained at pre-induction levels by NA infusion. In the control group (n = 12), NA was administered only if MAP decreased below 60 mmHg. Platelet aggregation (impedance aggregometry with ADP, arachidonic acid [AA] and thrombin-receptor activating peptide [TRAP] as initiators) and clot formation (clotting time, clot formation time and maximum clot firmness by EXTEM, INTEM and FIBTEM tests with thromboelastometry) were assessed before and 50 min after anesthesia induction (before cardiopulmonary bypass was initiated). Results All patients in the treatment group received NA (median dose after 50 min 0.09 (range 0-0.26) µg kg-1  min-1 ). Four patients in the control group also received NA (0.03-0.12 µg kg-1  min-1 ). There were differences between the treatment group and the control group in ADP- and AA-induced aggregation changes (ADP, +16 [25th-75th percentiles, 5-26] vs. -7 [-19 to -1] U; AA, +12 [-4 to 16] vs. -9 [-13 to 1] U). INTEM maximum clot firmness increased in the treatment group but not in the control group. Conclusion Infusion of clinically relevant doses of NA enhanced platelet aggregation and clot firmness in ASA-treated CABG patients. NA infusion is hence a potential new method to acutely improve platelet reactivity in patients on antiplatelet therapy undergoing surgery.


Assuntos
Aspirina/administração & dosagem , Perda Sanguínea Cirúrgica/prevenção & controle , Ponte de Artéria Coronária , Hemostáticos/administração & dosagem , Cuidados Intraoperatórios , Norepinefrina/administração & dosagem , Inibidores da Agregação de Plaquetas/administração & dosagem , Agregação Plaquetária/efeitos dos fármacos , Idoso , Aspirina/efeitos adversos , Ponte de Artéria Coronária/efeitos adversos , Esquema de Medicação , Feminino , Hemostáticos/efeitos adversos , Humanos , Infusões Parenterais , Cuidados Intraoperatórios/efeitos adversos , Masculino , Pessoa de Meia-Idade , Norepinefrina/efeitos adversos , Inibidores da Agregação de Plaquetas/efeitos adversos , Estudos Prospectivos , Suécia , Fatores de Tempo , Resultado do Tratamento
18.
Int J Hematol ; 109(3): 336-345, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30604312

RESUMO

Rurioctocog alfa (recombinant factor VIII: Advate®) is available for the control of bleeding in patients with hemophilia A in Japan. To evaluate the inhibitor development, safety, and efficacy of rurioctocog alfa, a non-interventional and observational postmarketing surveillance was conducted on 352 previously treated Japanese patients aged 1-76 years with ≥ 4 exposure days under the conditions of routine clinical practice. A post-hoc comparison of the mean annualized bleeding rates which required treatment with rurioctocog alfa detected a statistically significant difference (P < 0.0001) between patients treated on regular prophylaxis (8.5 bleeds/year) and patients treated on an on-demand basis (36.6 bleeds/year). Favorable prophylactic and on-demand hemostatic efficacy ("excellent" or "good") were shown in 88.5-100% of patients across all treatment regimens. A total of 22 events of adverse drug reactions were reported in 13 male patients. Of the 352 patients, 3 (0.9%) patients, all of whom had ≤ 50 exposure days before enrollment, developed de novo FVIII inhibitor. No deaths or allergic reactions were reported. Rurioctocog alfa was found to be well-tolerated and effective among patients with hemophilia A in a postmarketing routine clinical practice.


Assuntos
Inibidores dos Fatores de Coagulação Sanguínea , Hemofilia A , Hemostáticos/administração & dosagem , Vigilância de Produtos Comercializados , Adolescente , Adulto , Idoso , Inibidores dos Fatores de Coagulação Sanguínea/sangue , Criança , Pré-Escolar , Fator VIII/efeitos adversos , Feminino , Hemofilia A/sangue , Hemofilia A/tratamento farmacológico , Hemofilia A/epidemiologia , Hemorragia/sangue , Hemorragia/epidemiologia , Hemorragia/prevenção & controle , Hemostáticos/efeitos adversos , Humanos , Lactente , Japão/epidemiologia , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos
20.
J Thromb Haemost ; 17(3): 499-506, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30657628

RESUMO

Essentials In 2016 the SSC proposed definitions for effective hemostasis in management of major bleeding. To validate these definitions, we studied the use in three large anticoagulant-reversal studies. Method agreement analysis and interobserver reliability showed at least acceptable agreement. Recommendations were made, advising use of the definition in hemostatic effectiveness studies. SUMMARY: Introduction In 2016 the Scientific and Standardization Subcommittee (SSC) on Control of Anticoagulation of the International Society on Thrombosis and Haemostasis (ISTH) proposed criteria to evaluate the effectiveness of anticoagulant reversal in major bleeding management. Testing and validation of these criteria are required. Objective To investigate the method agreement, interobserver reliability and applicability of the ISTH proposed definitions for hemostatic effectiveness. Methods Patient data from three anticoagulant-antidote studies were used for hemostatic effectiveness assessment using the ISTH-proposed definitions and clinical opinion. For every patient a case document was produced. For each cohort, four adjudicators were asked to assess the hemostatic effectiveness independently on a case-by-case basis. Agreement between the two methods of hemostatic effectiveness assessment was calculated using Cohen's kappa (κ), with a calculated sample size of at least 73 cases. Results The full dataset consisted of 116 cases, resulting in 464 assessments. Method agreement in outcome was observed in 364 of 464 assessments (78.5%), resulting in κ of 0.634 (95% CI: 0.575-0.694), or "substantial agreement." Interobserver reliability analysis of the proposed definitions computed an overall agreement of 54.2% with κ of 0.312 ("fair agreement"). Discussion Method agreement analysis shows that the conclusions drawn using the ISTH definitions have "substantial agreement" with clinical opinion. Interobserver reliability analysis demonstrated acceptable agreement. In-depth analysis provided minor opportunities for further improvement and correct application of the definition. The definition is recommended to be used in all future studies evaluating hemostatic effectiveness, taking the suggested recommendations into account.


Assuntos
Anticoagulantes/efeitos adversos , Antídotos/uso terapêutico , Fatores de Coagulação Sanguínea/uso terapêutico , Hemorragia/terapia , Hemostasia/efeitos dos fármacos , Hemostáticos/uso terapêutico , Guias de Prática Clínica como Assunto , Terminologia como Assunto , Antídotos/efeitos adversos , Fatores de Coagulação Sanguínea/efeitos adversos , Consenso , Hemorragia/sangue , Hemorragia/induzido quimicamente , Hemostáticos/efeitos adversos , Humanos , Variações Dependentes do Observador , Resultado do Tratamento
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