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1.
Medicine (Baltimore) ; 100(10): e25099, 2021 Mar 12.
Artigo em Inglês | MEDLINE | ID: mdl-33725904

RESUMO

INTRODUCTION: The occurrence of massive hemorrhages in various emergency situations increases the need for blood transfusions and the risk of mortality. Use of fibrinogen concentrate (FC) may increase plasma fibrinogen levels more rapidly than the use of fresh-frozen product or cryoprecipitate. However, thus far, the efficacy of FC in significantly improving the risk of mortality and significantly reducing transfusion requirements has not been effectively demonstrated in several systematic reviews and meta-analyses. METHODS AND ANALYSIS: We will conduct a systematic review and meta-analysis of FC for hemorrhages in emergency situations. We will include controlled trials, but will exclude randomized controlled trials in elective surgeries. We will include patients with hemorrhages in emergency situations. Intervention will be emergency supplementation of FC. The control group will be administered with ordinal transfusion or placebo. The primary outcome of the study is in-hospital mortality.We will search in electronic databases such as MEDLINE (PubMed), Web of Science, and the Cochrane Central Register of Controlled Trials. Two reviewers will independently screen the title and abstract, retrieve the full text of the selected articles, and extract the essential data. We will apply uniform criteria for evaluating the risk of bias associated with individual randomized controlled trial based on the Cochrane risk of bias tool. Values of the risk ratio will be expressed as a point estimate with 95% confidence intervals (CIs). Data of continuous variables will be expressed as the mean difference along with their 95% CIs and P values. We will assess the strength of evidence using the Grading of Recommendations Assessment, Development and Evaluation approach. ETHICS AND DISSEMINATION: This systematic review will provide physicians with updated information on the efficacy and safety of using FC for hemorrhage in emergency settings. Approval from the ethics board and patient consent were not required in our study.This study protocol has been funded through a protocol registry. The registry number is UMIN000041598.


Assuntos
Transfusão de Sangue , Tratamento de Emergência/métodos , Fibrinogênio/administração & dosagem , Hemorragia/terapia , Hemostáticos/administração & dosagem , Ensaios Clínicos Controlados como Assunto , Fibrinogênio/efeitos adversos , Hemorragia/mortalidade , Hemostáticos/efeitos adversos , Mortalidade Hospitalar , Humanos , Metanálise como Assunto , Revisões Sistemáticas como Assunto , Resultado do Tratamento
2.
Drugs Today (Barc) ; 57(3): 219-239, 2021 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-33729219

RESUMO

Acquired hypofibrinogenemia is a frequent cause of maintained bleeding in perioperative high-risk settings. Loss, consumption and dilution under resuscitation fluid therapy are the principal causes for fibrinogen depletion. Severe hypofibrinogenemia is frequently associated with an early bleeding complication that cannot be reliably avoided with high-ratio plasma transfusion strategies. Real-time monitoring with viscoelastic hemostatic assays is a useful tool for timely diagnosis and treatment of detected coagulopathies. Replenishment of fibrinogen in uncontrolled bleeding events is currently recommended by most published guidelines, suggesting treatment thresholds to maintain a minimum of 1.5 g/L plasma fibrinogen concentration for nonobstetrical hemorrhage. Fibrinogen concentrates, originally licensed for treatment of bleeding episodes in patients with congenital hypo-, dys- or afibrinogenemia disorders, are used in many clinical situations as supplementary therapy for the treatment of acquired hypofibrinogenemia. This review seeks to provide an overview of the most relevant topics associated to fibrinogen replacement therapy for critical perioperative hemorrhage highlighting currently available evidence on the risk/benefit profile of purified fibrinogen concentrates for this extended clinical indication.


Assuntos
Fibrinogênio , Hemostáticos , Transfusão de Componentes Sanguíneos , Fibrinogênio/análise , Hemorragia/induzido quimicamente , Hemorragia/tratamento farmacológico , Hemostáticos/efeitos adversos , Humanos , Plasma/química
3.
Niger J Clin Pract ; 23(8): 1103-1109, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32788488

RESUMO

Background: Contamination is a common problem in pediatric restorative dentistry and there are a few studies that investigate blood contamination, hemostatic agents, and tooth dentin. Aim: The purpose of this study was to evaluate the effects of blood contamination and hemostatic agents on the bond strength of two different bonding systems with the dentin of primary teeth. Materials and Methods: Buccal and lingual dentin surfaces of 40 primary second molar teeth were used for this study. Specimens were divided into 4 groups according to the contamination and hemostatic agents (Blood-B, Ankaferd Blood Stopper-A, ViscoStat-V, Control-C) and then every group was further divided into two subgroups according to the bonding systems (Clearfil SE Bond-I, All Bond Universal-II, n = 10 per group). A bulk-fill composite resin was built-up on the surfaces. The specimens were tested in the micro shear mode at a crosshead speed of 1 mm/min on a universal test machine. Statistical analysis was performed with ANOVA and Tukey's tests at P < 0.05. Results: Significant differences have been detected in the micro shear bond strengths only between the Ankaferd Blood Stopper (ABS) (AI = 13.72 ± 4.47 and AII = 9.12 ± 4.4) and control groups (CI = 22.78 ± 10.86 and CII = 16.49 ± 6.55) without regards to the bonding systems. The highest scores were obtained in the control groups. Clearfil SE Bond showed better performance than All Bond Universal in all groups. Conclusion: It was determined that only the ABS contamination groups showed statistically significant decreases in the bond strengths when compared with control groups.


Assuntos
Sangue , Resinas Compostas/química , Colagem Dentária , Adesivos Dentinários/química , Hemostáticos/efeitos adversos , Análise do Estresse Dentário , Dentina , Humanos , Teste de Materiais , Dente Molar , Cimentos de Resina , Resistência ao Cisalhamento , Dente Decíduo
4.
Eur J Vasc Endovasc Surg ; 60(3): 469-478, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32620348

RESUMO

OBJECTIVE: In vascular and cardiac surgery, the ability to maintain haemostasis and seal haemorrhagic tissues is key. Fibrin and thrombin based sealants were introduced as a means to prevent or halt bleeding during surgery. Whether fibrin and thrombin sealants affect surgical outcomes is poorly established. A systematic review and meta-analysis was performed to examine the impact of fibrin or thrombin sealants on patient outcomes in vascular and cardiac surgery. DATA SOURCES: Cochrane CENTRAL, Embase, and MEDLINE, as well as trial registries, conference abstracts, and reference lists of included articles were searched from inception to December 2019. REVIEW METHODS: Studies comparing the use of fibrin or thrombin sealant with either an active (other haemostatic methods) or standard surgical haemostatic control in vascular and cardiac surgery were searched for. The Cochrane risk of bias tool and the ROBINS-I tool (Risk Of Bias In Non-randomised Studies - of Interventions) were used to assess the risk of bias of the included randomised and non-randomised studies; quality of evidence was assessed by the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework. Two reviewers screened studies, assessed risk of bias, and extracted data independently and in duplicate. Data from included trials were pooled using a random effects model. RESULTS: Twenty-one studies (n = 7 622 patients) were included: 13 randomised controlled trials (RCTs), five retrospective, and three prospective cohort studies. Meta-analysis of the RCTs showed a statistically significant decrease in the volume of blood lost (mean difference 120.7 mL, in favour of sealant use [95% confidence interval {CI} -150.6 - -90.7; p < .001], moderate quality). Time to haemostasis was also shown to be reduced in patients receiving sealant (mean difference -2.5 minutes [95% CI -4.0 - -1.1; p < .001], low quality). Post-operative blood transfusions, re-operation due to bleeding, and 30 day mortality were not significantly different for either RCTs or observational data. CONCLUSION: The use of fibrin and thrombin sealants confers a statistically significant but clinically small reduction in blood loss and time to haemostasis; it does not reduce blood transfusion. These Results may support selective rather than routine use of fibrin and thrombin sealants in vascular and cardiac surgery.


Assuntos
Perda Sanguínea Cirúrgica/prevenção & controle , Procedimentos Cirúrgicos Cardíacos , Adesivo Tecidual de Fibrina/administração & dosagem , Hemostasia , Hemostáticos/administração & dosagem , Hemorragia Pós-Operatória/prevenção & controle , Trombina/administração & dosagem , Adesivos Teciduais/administração & dosagem , Procedimentos Cirúrgicos Vasculares , Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Adesivo Tecidual de Fibrina/efeitos adversos , Hemostáticos/efeitos adversos , Humanos , Hemorragia Pós-Operatória/etiologia , Fatores de Risco , Trombina/efeitos adversos , Fatores de Tempo , Adesivos Teciduais/efeitos adversos , Resultado do Tratamento , Procedimentos Cirúrgicos Vasculares/efeitos adversos
6.
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
8.
Thromb Haemost ; 120(5): 737-746, 2020 May.
Artigo em Inglês | MEDLINE | ID: mdl-32369845

RESUMO

Long-term safety and efficacy data of extended half-life factor IX (FIX) prophylaxis in children with hemophilia B (HB) are sparse. paradigm 5 is a multinational, open-label, single-arm, phase III trial assessing once-weekly (40 IU/kg) prophylactic nonacog beta pegol (N9-GP) in previously treated patients (PTPs) aged ≤ 12 years with HB (FIX activity ≤ 2%). Primary endpoint: incidence of anti-FIX inhibitory antibodies (≥ 0.6 Bethesda Units). We present a 5-year analysis (N = 25, including remaining patients with ≥ 5 years' follow-up) and compare with a 1-year analysis (≥ 52 weeks' exposure). The main phase enrolled 25 children; 22 entered the extension phase; 17 remained in trial at data cutoff. Median treatment period: 5.6 years/patient; median total number of N9-GP exposure days: 290.0/patient. No patients developed anti-FIX inhibitory antibodies. No other safety concerns, including thromboembolic events, were reported. Neurological examinations have not revealed any new abnormal findings. Sixteen (64.0%) patients remained free from spontaneous bleeds; all bleeds were mild/moderate in severity; 93.0% were controlled with 1 to 2 N9-GP injections. No intracranial hemorrhages were reported. Annualized bleeding rates (ABRs) were very low at 5 years (median/Poisson-estimated mean overall ABR: 0.66/0.99), having decreased from the 1-year analysis (1.00/1.44). Median/Poisson-estimated mean spontaneous ABRs for the 1- and 5-year analyses: 0.00/0.45 and 0.00/0.33. Mean FIX trough activity at 5 years: 17.9%. Mean polyethylene glycol plasma concentration reached steady state at 6 months, increasing slightly over time, in line with increased FIX trough activity. N9-GP administered for ≥ 5 years shows favorable long-term safety and efficacy in PTPs with HB (FIX activity ≤ 2%).


Assuntos
Fator IX/administração & dosagem , Hemofilia B/tratamento farmacológico , Hemostáticos/administração & dosagem , Polietilenoglicóis/administração & dosagem , Adolescente , Fatores Etários , Ásia , Criança , Pré-Escolar , Esquema de Medicação , Europa (Continente) , Fator IX/efeitos adversos , Fator IX/farmacocinética , Hemofilia B/sangue , Hemofilia B/diagnóstico , Hemorragia/sangue , Hemorragia/diagnóstico , Hemorragia/prevenção & controle , Hemostáticos/efeitos adversos , Hemostáticos/sangue , Hemostáticos/farmacocinética , Humanos , Lactente , América do Norte , Segurança do Paciente , Polietilenoglicóis/efeitos adversos , Polietilenoglicóis/farmacocinética , Proteínas Recombinantes/administração & dosagem , Proteínas Recombinantes/efeitos adversos , Proteínas Recombinantes/sangue , Proteínas Recombinantes/farmacocinética , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
9.
Thromb Haemost ; 120(5): 747-757, 2020 May.
Artigo em Inglês | MEDLINE | ID: mdl-32369846

RESUMO

BACKGROUND: The currently published population pharmacokinetic (PK) models used for PK-guided dosing in hemophilia patients are based on clinical trial data and usually not externally validated in clinical practice. The aim of this study was to validate a published model for recombinant factor VIII-Fc fusion protein (rFVIII-Fc) concentrate and to develop an enriched model using independently collected clinical data if required. METHODS: Clinical data from hemophilia A patients treated with rFVIII-Fc concentrate (Elocta) participating in the United Kingdom Extended Half-Life Outcomes Registry were collected. The predictive performance of the published model was assessed using mean percentage error (bias) and mean absolute percentage error (inaccuracy). An extended population PK model was developed using nonlinear mixed-effects modeling (NONMEM). RESULTS: A total of 43 hemophilia A patients (FVIII ≤ 2 IU/dL), aged 5 to 70 years, were included. The prior model was able to predict the collected 244 rFVIII-Fc levels without significant bias (-1.0%, 95% CI: -9.4 to 7.3%) and with acceptable accuracy (12.9%). However, clearance and central distribution volume were under predicted in patients <12 years, which was expected as this age group was not represented in the previous model population. An enriched population PK model was constructed, which was able to successfully characterize PK profiles of younger children. CONCLUSION: We concluded that the existing rFVIII-Fc population PK model is valid for patients ≥ 12 years. However, it is not reliable in younger patients. Our alternative model, constructed from real world patient data including children, allows for better description of patients ≥5 years.


Assuntos
Fator VIII/farmacocinética , Hemofilia A/tratamento farmacológico , Hemostáticos/farmacocinética , Modelos Biológicos , Proteínas Recombinantes de Fusão/farmacocinética , Adolescente , Adulto , Fatores Etários , Idoso , Criança , Fator VIII/administração & dosagem , Fator VIII/efeitos adversos , Hemofilia A/sangue , Hemofilia A/diagnóstico , Hemostáticos/administração & dosagem , Hemostáticos/efeitos adversos , Humanos , Fragmentos Fc das Imunoglobulinas/administração & dosagem , Fragmentos Fc das Imunoglobulinas/efeitos adversos , Masculino , Pessoa de Meia-Idade , Países Baixos , Proteínas Recombinantes de Fusão/administração & dosagem , Proteínas Recombinantes de Fusão/efeitos adversos , Sistema de Registros , Reprodutibilidade dos Testes , Reino Unido , Adulto Jovem
10.
Cerebrovasc Dis ; 49(2): 177-184, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32320990

RESUMO

BACKGROUND: Prevention of hematoma enlargement in oral anticoagulation-associated intracerebral hemorrhage (OAC-ICH) focuses on blood pressure (BP) reduction and OAC reversal. We investigated whether treatment efficiency and clinical outcomes differ between OAC-ICH patients admitted outside versus during regular working hours. METHODS: Based on pooled data of multicenter cohort studies, we grouped OAC-ICH patients (vitamin K antagonist [VKA], non-vitamin K oral anticoagulant [NOAC]) according to on- vs. off-hour admission. Primary outcome was the functional outcome using the modified Rankin scale (mRS) dichotomized into favorable (mRS 0-3) and unfavorable (mRS 4-6) and mortality at 3 months. Secondary outcome measures included the occurrence of hematoma enlargement, the proportions of patients with systolic BP <140 mm Hg and with anticoagulation treatment achieving international normalized ratio (INR) levels <1.3 at 4 h. Propensity score matching (PSM) was performed to account for imbalances in baseline characteristics. RESULTS: The study population consisted of 76/126 NOAC-ICH patients and 1,005/1,470 VKA patients presenting during off-hours. Functional outcome and mortality rates were not significantly different among PSM patients with VKA-ICH and NOAC-ICH during on- vs. off-hours (mRS 4-6 VKA-ICH: on-hour: 239/357 [66.9%] vs. 253/363 [69.7%] off-hour; p = 0.43; NOAC-ICH: on-hour 26/42 [61.9%] vs. off-hour: 37/57 [64.9%]; p = 0.76; mRS 6 VKA-ICH: on-hour: 127/357 [35.6%] vs. off-hour: 148/363 [40.8%]; p = 0.15; -NOAC-ICH: on-hour 17/42 [40.5%] vs. off-hour: 16/57 [28.1%]; p = 0.20). There were no differences detectable regarding the secondary outcome measures (i.e., hematoma enlargement, the proportion of patients who achieved systolic BP levels <140 mm Hg at 4 h as well as anticoagulation treatment achieving INR levels <1.3 at 4 h) in OAC patients. CONCLUSION: Our study implies that BP reduction and anticoagulation reversal management are well established and associated with similar rates of hematoma enlargement and clinical outcomes in on- vs. off-hour admitted OAC-ICH patients.


Assuntos
Plantão Médico , Anticoagulantes/efeitos adversos , Coagulação Sanguínea/efeitos dos fármacos , Pressão Sanguínea/efeitos dos fármacos , Hemorragia Cerebral/tratamento farmacológico , Hematoma/tratamento farmacológico , Hemostáticos/administração & dosagem , Administração Oral , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/administração & dosagem , Hemorragia Cerebral/induzido quimicamente , Hemorragia Cerebral/mortalidade , Hemorragia Cerebral/fisiopatologia , Avaliação da Deficiência , Progressão da Doença , Feminino , Alemanha , Hematoma/induzido quimicamente , Hematoma/mortalidade , Hematoma/fisiopatologia , Hemostáticos/efeitos adversos , Humanos , Coeficiente Internacional Normatizado , Masculino , Estudos Multicêntricos como Assunto , Recuperação de Função Fisiológica , Estudos Retrospectivos , Fatores de Tempo , Resultado do Tratamento
11.
Arterioscler Thromb Vasc Biol ; 40(5): 1148-1154, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32237902

RESUMO

Emicizumab is a humanized anti-FIXa/FX (factor IXa/X) bispecific monoclonal antibody that mimics FVIIIa (activated factor VIII) cofactor function. The hemostatic efficacy of emicizumab has been confirmed in clinical studies of patients with hemophilia A, irrespective of the presence of FVIII inhibitors. Emicizumab differs in some properties from FVIIIa molecule. Emicizumab requires no activation by thrombin and is not inactivated by activated protein C, but emicizumab-mediated coagulation is regulatable and maintains hemostasis. A small amount of FIXa (activated factor IX) is required to initiate emicizumab-mediated hemostasis, whereas tissue factor/FVIIa (activated factor VII)-mediated FXa (activated factor X) and thrombin activation initiates FVIIIa-mediated hemostasis. Fibrin formation, followed by fibrinolysis, appears to be similar between emicizumab- and FVIIIa-mediated hemostasis. These results suggest possible future uses of emicizumab for treating hemorrhagic diseases other than hemophilia A and reveal previously unobservable behaviors of procoagulation and anticoagulation factors in conventional hemostasis. Here, we have reviewed novel insights and new developments regarding coagulation highlighted by emicizumab.


Assuntos
Anticorpos Biespecíficos/uso terapêutico , Anticorpos Monoclonais Humanizados/uso terapêutico , Coagulação Sanguínea/efeitos dos fármacos , Hemofilia A/tratamento farmacológico , Hemostáticos/uso terapêutico , Animais , Anticorpos Biespecíficos/efeitos adversos , Anticorpos Monoclonais Humanizados/efeitos adversos , Hemofilia A/sangue , Hemofilia A/diagnóstico , Hemostáticos/efeitos adversos , Humanos , Fatores de Risco , Resultado do Tratamento
12.
World Neurosurg ; 137: 183-186, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32035204

RESUMO

BACKGROUND: An 11-year-old girl had undergone posterior spinal fusion surgery for scoliosis. The surgery was complicated by intraoperative bleeding, and hemostasis was achieved by topically applying gelatin sponges. CASE DESCRIPTION: She developed acute pulmonary embolism and cardiac arrest during the surgery, which was confirmed by transesophageal echocardiography. CONCLUSIONS: Autopsy shortly after revealed that her death was associated with unintended intravascular entry of gelatin sponge fragments, resulting in an embolic event and secondary cardiopulmonary collapse.


Assuntos
Perda Sanguínea Cirúrgica , Migração de Corpo Estranho/complicações , Esponja de Gelatina Absorvível/efeitos adversos , Hemostáticos/efeitos adversos , Complicações Intraoperatórias/etiologia , Embolia Pulmonar/etiologia , Escoliose/cirurgia , Fusão Vertebral , Criança , Ecocardiografia Transesofagiana , Evolução Fatal , Feminino , Migração de Corpo Estranho/patologia , Hemostasia Cirúrgica , Humanos , Complicações Intraoperatórias/diagnóstico por imagem , Complicações Intraoperatórias/patologia , Embolia Pulmonar/diagnóstico por imagem , Embolia Pulmonar/patologia
13.
Biomater Sci ; 8(5): 1455-1463, 2020 Mar 03.
Artigo em Inglês | MEDLINE | ID: mdl-31960840

RESUMO

In this work, a biocompatible poly(N-hydroxyethyl acrylamide) (PHEAA) polymer with hydrogen bonding acceptors and donors in its side chains is prepared and mixed with tannic acid (TA) to form a supramolecular coacervate hydrogel (TAHE) due to multiple hydrogen-bonding interactions between TA and PHEAA. The coacervate TAHE hydrogel exhibits not only self-healing and antibacterial properties, but also strong adhesion to various substrates, with average adhesion strengths of 722 kPa, 522 kPa, 484 kPa, and 322 kPa to the substrates of iron, PMMA, ceramics, and glass, respectively. Notably, the hydrogel reformed by the rehydration of freeze-dried and ground TAHE hydrogel powder retains the initial adhesive performance and exhibits an excellent hemostatic ability. This novel adhesive hydrogel holds great potential as an adhesive hemostatic material for self-rescue in emergency situations.


Assuntos
Adesivos/química , Antibacterianos/química , Hemostáticos/química , Hidrogéis/química , Resinas Acrílicas/química , Adesivos/efeitos adversos , Adesivos/farmacologia , Animais , Antibacterianos/efeitos adversos , Antibacterianos/farmacologia , Linhagem Celular , Fibroblastos/efeitos dos fármacos , Hemólise/efeitos dos fármacos , Hemostáticos/efeitos adversos , Hemostáticos/farmacologia , Hidrogéis/efeitos adversos , Hidrogéis/farmacologia , Ligação de Hidrogênio , Masculino , Camundongos , Polimetil Metacrilato/química , Ratos , Ratos Sprague-Dawley , Staphylococcus/efeitos dos fármacos , Taninos/química
14.
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
15.
J Trauma Acute Care Surg ; 88(1): e1-e21, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-31626024

RESUMO

Uncontrolled exsanguination remains the leading cause of death for trauma patients, many of whom die in the pre-hospital setting. Without expedient intervention, trauma-associated hemorrhage induces a host of systemic responses and acute coagulopathy of trauma. For this reason, health care providers and prehospital personal face the challenge of swift and effective hemorrhage control. The utilization of adjuncts to facilitate hemostasis was first recorded in 1886. Commercially available products haves since expanded to include topical hemostats, surgical sealants, and adhesives. The ideal product balances efficacy, with safety practicality and cost-effectiveness. This review of hemostasis provides a guide for successful implementation and simultaneously highlights future opportunities.


Assuntos
Hemorragia/terapia , Técnicas Hemostáticas/normas , Hemostáticos/administração & dosagem , Ferimentos e Lesões/complicações , Administração Tópica , Hemorragia/etiologia , Técnicas Hemostáticas/efeitos adversos , Técnicas Hemostáticas/tendências , Hemostáticos/efeitos adversos , Humanos , Guias de Prática Clínica como Assunto
16.
Surg Endosc ; 34(1): 317-324, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-30927124

RESUMO

BACKGROUND AND AIMS: Despite advances in pharmacological and endoscopic management of non-variceal upper gastrointestinal bleeding (NVUGIB), mortality is still relevant. TC-325 (Hemospray-Cook Medical) is a mineral powder with adsorptive properties, designed for endoscopic hemostasis. There are still no comparative trials studying this new hemostatic modality. The objective of this research was to compare the use of TC-325 (associated with epinephrine injection) with the combined technique of endoscopic clipping and epinephrine injection for the treatment of patients with NVUGIB. METHODS: We conducted a pilot randomized controlled trial with patients that presented NVUGIB with an actively bleeding lesion at the endoscopic evaluation. Patients were randomized either to the Hemospray or Hemoclip group. The randomization list was generated by a computer program and remained unknown throughout the entire trial. All patients underwent second-look endoscopy. RESULTS: Thirty-nine patients were enrolled. Peptic ulcer was the most frequent etiology. Primary hemostasis was achieved in all Hemospray cases and in 90% of Hemoclip group (p = 0.487). Five patients in Hemospray group underwent an additional hemostatic procedure during second-look endoscopy, while no patient in the Hemoclip group needed it (p = 0.04). Rebleeding, emergency surgery and mortality rates were similar in both groups. No toxicity, allergy events, or gastrointestinal obstruction signs were observed in Hemospray group. CONCLUSIONS: TC-325 presents similar hemostatic results when compared with conventional dual therapy for patients with NVUGIB. Hemospray's excellent primary hemostasis rate certifies it as a valuable tool in arduous situations of severe bleeding or difficult location site.


Assuntos
Úlcera Duodenal/complicações , Hemostase Endoscópica , Minerais/administração & dosagem , Úlcera Péptica Hemorrágica , Úlcera Gástrica/complicações , Feminino , Hemostase Endoscópica/efeitos adversos , Hemostase Endoscópica/métodos , Hemostáticos/administração & dosagem , Hemostáticos/efeitos adversos , Humanos , Masculino , Pessoa de Meia-Idade , Minerais/efeitos adversos , Úlcera Péptica Hemorrágica/etiologia , Úlcera Péptica Hemorrágica/patologia , Úlcera Péptica Hemorrágica/cirurgia , Pós/administração & dosagem , Pós/efeitos adversos , Recidiva , Reoperação/estatística & dados numéricos , Resultado do Tratamento
17.
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
18.
BMC Nephrol ; 20(1): 413, 2019 11 15.
Artigo em Inglês | MEDLINE | ID: mdl-31730448

RESUMO

BACKGROUND: Desmopressin is used to reduce bleeding after kidney biopsy but evidence supporting its use is weak, especially in patients with elevated creatinine. The present study was undertaken to evaluate efficacy of desmopressin in reducing bleeding after percutaneous kidney biopsy. METHODS: Retrospective cohort study. 269 of 322 patients undergoing percutaneous kidney biopsy between January 1, 2014 and January 31, 2018 were included. Patients had normal bleeding time, platelet count and coagulation profile. Primary outcome was defined as composite of hemoglobin drop ≥1 g/dL, hematoma on post biopsy ultrasound, gross hematuria, erythrocyte transfusion or angiography to stop bleeding. Association of desmopressin with outcomes was assessed using linear (for continuous variables) and logistic (for binary variables) regression models. Propensity score was used to minimize potential confounding. RESULTS: Desmopressin was administered to 100/269 (37.17%) patients. After propensity score adjustment patients who received desmopressin had increased odds of post biopsy bleeding [OR 3.88 (1.95-7.74), p < 0.001]. Creatinine at time of biopsy influenced bleeding risk; gender, emergent vs elective biopsy, obesity, AKI, diabetes, hypertension or bleeding time did not influence bleeding risk. Administration of desmopressin to patients with serum creatinine ≥1.8 mg/dL decreased bleeding risk [OR 2.11 (95% CI 0.87-5.11), p = 0.09] but increased bleeding risk when serum creatinine was < 1.8 mg/dL (OR 9.72 (95% CI 2.95-31.96), p < 0.001). CONCLUSION: Desmopressin should not be used routinely prior to percutaneous kidney biopsy in patients at low risk for bleeding but should be reserved for patients who are at high risk for bleeding.


Assuntos
Biópsia/efeitos adversos , Creatinina/sangue , Desamino Arginina Vasopressina , Nefropatias/diagnóstico , Rim , Hemorragia Pós-Operatória , Angiografia/métodos , Angiografia/estatística & dados numéricos , Biópsia/métodos , Coagulação Sanguínea/efeitos dos fármacos , Desamino Arginina Vasopressina/administração & dosagem , Desamino Arginina Vasopressina/efeitos adversos , Feminino , Hemostasia Cirúrgica/estatística & dados numéricos , Hemostáticos/administração & dosagem , Hemostáticos/efeitos adversos , Humanos , Rim/irrigação sanguínea , Rim/patologia , Nefropatias/epidemiologia , Testes de Função Renal , Masculino , Pessoa de Meia-Idade , Avaliação de Processos e Resultados em Cuidados de Saúde , Seleção de Pacientes , Hemorragia Pós-Operatória/sangue , Hemorragia Pós-Operatória/diagnóstico , Hemorragia Pós-Operatória/prevenção & controle , Hemorragia Pós-Operatória/terapia , Estudos Retrospectivos , Ultrassonografia/métodos , Estados Unidos/epidemiologia
19.
Crit Care Med ; 47(12): 1759-1765, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31567345

RESUMO

OBJECTIVE: Current international guidelines offer a conditional recommendation to consider a single dose of IV desmopressin (DDAVP) for antiplatelet-associated intracranial hemorrhage based on low-quality evidence. We provide the first comparative assessment analyzing DDAVP effectiveness and safety in antiplatelet-associated intracranial hemorrhage. DESIGN: Retrospective chart review. SETTING: Single tertiary care academic medical center. PATIENTS: Adult patients taking at least one antiplatelet agent based on presenting history and documented evidence of intracranial hemorrhage on cerebral CT scan were included. Patients were excluded for the following reasons: repeat cerebral CT scan not performed within the first 24 hours, noncomparative repeat cerebral CT scan, chronic anticoagulation, administration of fibrinolytic medications, concurrent ischemic stroke, and neurosurgical intervention. In total, 124 patients were included, 55 received DDAVP and 69 did not. INTERVENTIONS: DDAVP treatment at recognition of antiplatelet-associated intracranial hemorrhage versus nontreatment. MEASUREMENTS AND MAIN RESULTS: Primary effectiveness outcome was intracranial hemorrhage expansion greater than or equal to 3 mL during the first 24 hospital hours. Primary safety outcomes were the largest absolute decrease from baseline serum sodium during the first 3 treatment days and new-onset thrombotic events during the first 7 days. DDAVP was associated with 88% decreased likelihood of intracranial hemorrhage expansion during the first 24 hours ([+] DDAVP, 10.9% vs [-] DDAVP, 36.2%; p = 0.002; odds ratio [95% CI], 0.22 [0.08-0.57]). Largest median absolute decrease from baseline serum sodium ([+] DDAVP, 0 mEq/L [0-5 mEq/L] vs [-] DDAVP, 0 mEq/L [0-2 mEq/L]; p = 0.089) and thrombotic events ([+] DDAVP, 7.3% vs [-] DDAVP, 1.4%; p = 0.170; odds ratio [95% CI], 5.33 [0.58-49.16]) were similar between groups. CONCLUSIONS: DDAVP was associated with a decreased likelihood of intracranial hemorrhage expansion during the first 24 hours. DDAVP administration did not significantly affect serum sodium and thrombotic events during the study period.


Assuntos
Desamino Arginina Vasopressina/uso terapêutico , Hemostáticos/uso terapêutico , Hemorragias Intracranianas/induzido quimicamente , Hemorragias Intracranianas/tratamento farmacológico , Inibidores da Agregação Plaquetária/efeitos adversos , Idoso , Idoso de 80 Anos ou mais , Desamino Arginina Vasopressina/efeitos adversos , Feminino , Hemostáticos/efeitos adversos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Resultado do Tratamento
20.
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
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