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1.
JAMA ; 323(2): 130-139, 2020 01 14.
Artigo em Inglês | MEDLINE | ID: mdl-31935028

RESUMO

Importance: The efficacy of factor XIa inhibition for thromboprophylaxis is unknown. Osocimab is a long-acting, fully human monoclonal antibody that inhibits factor XIa. Objective: To compare different doses of osocimab with enoxaparin and apixaban for thromboprophylaxis in patients who have undergone knee arthroplasty. Design, Setting, and Participants: Randomized, open-label, adjudicator-blinded, phase 2 noninferiority trial with observer blinding for osocimab doses, conducted at 54 hospitals in 13 countries. Adult patients undergoing unilateral knee arthroplasty were randomized from October 2017 through August 2018 and followed up until January 2019. Interventions: Single intravenous osocimab postoperative doses of 0.3 mg/kg (n = 107), 0.6 mg/kg (n = 65), 1.2 mg/kg (n = 108), or 1.8 mg/kg (n = 106); preoperative doses of 0.3 mg/kg (n = 109) or 1.8 mg/kg (n = 108); or 40 mg of subcutaneous enoxaparin once daily (n = 105) or 2.5 mg of oral apixaban twice daily (n = 105) for at least 10 days or until venography. Main Outcomes and Measures: The primary outcome was venous thromboembolism incidence between 10 and 13 days postoperatively (assessed by mandatory bilateral venography performed 10 to 13 days after surgery or confirmed symptomatic deep vein thrombosis or pulmonary embolism). A 5% noninferiority margin compared with enoxaparin was chosen. The primary safety outcome of major or clinically relevant nonmajor bleeding was assessed until 10 to 13 days postoperatively. Results: Of 813 randomized participants (mean [SD] age, 66.5 years [8.2 years]; body mass index, 32.7 [5.7]; and 74.2% women), 600 were included in the per-protocol population used for the primary analysis. The primary outcome occurred in 18 patients (23.7%) receiving 0.3 mg/kg, 8 (15.7%) receiving 0.6 mg/kg, 13 (16.5%) receiving 1.2 mg/kg, and 14 (17.9%) receiving 1.8 mg/kg of osocimab postoperatively; 23 (29.9%) receiving 0.3 mg/kg and 9 (11.3%) receiving 1.8 mg/kg of osocimab preoperatively; 20 (26.3%) receiving enoxaparin; and 12 (14.5%) receiving apixaban. Osocimab given postoperatively met criteria for noninferiority compared with enoxaparin with risk differences (1-sided 95% CIs) of 10.6% (95% CI, -1.2% to ∞) at the 0.6-mg/kg dose; 9.9% (95% CI, -0.9% to ∞) at the 1.2-mg/kg dose, and 8.4% (95% CI, -2.6 to ∞) at the 1.8-mg/kg dose. The preoperative dose of 1.8 mg/kg of osocimab met criteria for superiority compared with enoxaparin with a risk difference of 15.1%; 2-sided 90% CI, 4.9% to 25.2%). Postoperative and preoperative doses of 0.3 mg/kg of osocimab did not meet the prespecified criteria for noninferiority, with risk differences (1-sided 95% CIs) of 2.6% (95% CI, -8.9% to ∞) and -3.6% (95% CI, -15.5% to ∞), respectively. Major or clinically relevant nonmajor bleeding was observed in up to 4.7% of those receiving osocimab, 5.9% receiving enoxaparin, and 2% receiving apixaban. Conclusions and Relevance: Among patients undergoing knee arthroplasty, postoperative osocimab 0.6 mg/kg, 1.2 mg/kg, and 1.8 mg/kg met criteria for noninferiority compared with enoxaparin, and the preoperative 1.8-mg/kg dose of osocimab met criteria for superiority compared with enoxaparin for the primary outcome of incidence of venous thromboembolism at 10 to 13 days postoperatively. Further studies are needed to establish efficacy and safety of osocimab relative to standard thromboprophylaxis. Trial Registration: ClinicalTrials.gov Identifier: NCT03276143.


Assuntos
Anticoagulantes/administração & dosagem , Artroplastia do Joelho , Inibidores do Fator Xa/administração & dosagem , Hemorragia/induzido quimicamente , Complicações Pós-Operatórias/prevenção & controle , Tromboembolia Venosa/prevenção & controle , Idoso , Anticoagulantes/efeitos adversos , Relação Dose-Resposta a Droga , Enoxaparina/administração & dosagem , Enoxaparina/efeitos adversos , Inibidores do Fator Xa/efeitos adversos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Cuidados Pré-Operatórios , Embolia Pulmonar/prevenção & controle , Pirazóis/administração & dosagem , Pirazóis/efeitos adversos , Piridonas/administração & dosagem , Piridonas/efeitos adversos , Método Simples-Cego , Trombose Venosa/prevenção & controle
3.
Dis Colon Rectum ; 62(11): 1381-1389, 2019 11.
Artigo em Inglês | MEDLINE | ID: mdl-31318768

RESUMO

BACKGROUND: There is increasing evidence to support extended thromboprophylaxis after colorectal surgery to minimize the incidence of postdischarge venous thromboembolic events. However, the absolute number of events is small, and extended thromboprophylaxis requires significant resources from the health care system. OBJECTIVE: This study aimed to determine the cost-effectiveness of extended thromboprophylaxis in patients undergoing colorectal surgery for malignancy or IBD. DESIGN: An individualized patient microsimulation model (1,000,000 patients; 1-month cycle length) comparing extended thromboprophylaxis (28-day course of enoxaparin) to standard management (inpatient administration only) after colorectal surgery was constructed. SETTINGS: The sources for this study were The American College of Surgeons National Surgical Quality Improvement Project Participant User File and literature searches. OUTCOMES: Costs (Canadian dollars), quality-adjusted life-years, and venous thromboembolism-related deaths prevented over a 1-year time horizon starting with hospital discharge were determined. The results were stratified by malignancy or IBD. RESULTS: In patients with malignancy, extended prophylaxis was associated with higher costs (+113$; 95% CI, 102-123), but increased quality-adjusted life-years (+0.05; 95% CI, 0.04-0.06), resulting in an incremental cost-effectiveness ratio of 2473$/quality-adjusted life-year. For IBD, extended prophylaxis also had higher costs (+116$; 95% CI, 109-123), more quality-adjusted life-years (+0.05; 95% CI, 0.04-0.06), and an incremental cost-effectiveness ratio of 2475$/quality-adjusted life-year. Extended prophylaxis prevented 16 (95% CI, 4-27) venous thromboembolism-related deaths per 100,000 patients and 22 (95% CI, 6-38) for malignancy and IBD. There was a 99.7% probability of cost-effectiveness at a willingness-to-pay threshold of 50,000$/quality-adjusted life-year. To account for statistical uncertainty around variables, sensitivity analysis was performed and found that extended prophylaxis is associated with lower overall costs when the incidence of postdischarge venous thromboembolic events reaches 1.8%. LIMITATIONS: Significant differences in health care systems may affect the generalizability of our results. CONCLUSIONS: Despite the rarity of venous thromboembolic events, extended thromboprophylaxis is a cost-effective strategy. See Video Abstract at http://links.lww.com/DCR/A976. COSTO-EFECTIVIDAD DE LA TROMBOPROFILAXIS EXTENDIDA EN PACIENTES SOMETIDOS A CIRUGÍA COLORRECTAL DESDE UNA PERSPECTIVA DEL SISTEMA DE SALUD CANADIENSE:: Cada vez hay más pruebas que apoyen la tromboprofilaxis extendida después de la cirugía colorrectal para minimizar la incidencia de eventos tromboembólicos venosos después del alta hospitalaria. Sin embargo, el número absoluto de eventos es pequeño y la tromboprofilaxis extendida requiere recursos significativos del sistema médico.Determinar la rentabilidad (relación costo-efectividad) de la tromboprofilaxis extendida en pacientes sometidos a cirugía colorrectal por neoplasia maligna o enfermedad inflamatoria intestinal.Un modelo de microsimulación de paciente individualizado (1,000,000 de pacientes; ciclo de 1 mes) que compara la tromboprofilaxis extendida (curso de enoxaparina de 28 días) con el tratamiento estándar (solo para pacientes hospitalizados) después de la cirugía colorrectal.Archivo de usuario participante del Proyecto de Mejoramiento de la Calidad Quirúrgica del Colegio Nacional de Cirujanos Americanos (ACS-NSQIP) y búsquedas bibliográficas.Costos (en dólares Canadienses), años de vida ajustados por la calidad y muertes relacionadas con el tromboembolismo venoso prevenidas en un horizonte temporal de 1 año a partir del alta hospitalaria. Los resultados fueron estratificados por malignidad o enfermedad inflamatoria intestinal.En pacientes con neoplasias malignas, la profilaxis extendida se asoció con costos más altos (+113 $; IC del 95%, 102-123), pero con un aumento de la calidad de vida ajustada por años de vida (+0.05; IC del 95%, 0.04-0.06), lo que resultó en un incremento de relación costo-efectividad de 2473 $/año de vida ajustado por calidad. Para la enfermedad inflamatoria intestinal, la profilaxis extendida también tuvo costos más altos (+116 $; 95% IC, 109-123), más años de vida ajustados por calidad (+0.05; 95% IC, 0.04-0.06) y una relación costo-efectividad incremental de 2475 $/año de vida ajustado por calidad. La profilaxis prolongada evitó 16 (95% IC, 4-27) muertes relacionadas con tromboembolismo venoso por cada 100,000 pacientes y 22 (95% IC, 6-38) por malignidad y enfermedad inflamatoria intestinal, respectivamente. Hubo un 99.7% de probabilidad de costo-efectividad en un límite de disposición a pagar de 50,000 $/año de vida ajustado por calidad. Para tener en cuenta la incertidumbre estadística en torno a los variables, se realizó un análisis de sensibilidad y se encontró que la profilaxis extendida se asocia con menores costos generales cuando la incidencia de eventos tromboembólicos venosos después del alta hospitalaria alcanza 1.8%.Las diferencias significativas en los sistemas de salud pueden afectar la generalización de nuestros resultados.A pesar de la escasez de eventos tromboembólicos venosos, la tromboprofilaxis extendida es una estrategia rentable. Vea el video del resumen en http://links.lww.com/DCR/A976.


Assuntos
Quimioprevenção , Colectomia/efeitos adversos , Enoxaparina , Complicações Pós-Operatórias , Tromboembolia Venosa , Anticoagulantes/administração & dosagem , Anticoagulantes/efeitos adversos , Anticoagulantes/economia , Quimioprevenção/economia , Quimioprevenção/métodos , Colectomia/métodos , Neoplasias do Colo/cirurgia , Análise Custo-Benefício , Técnicas de Apoio para a Decisão , Enoxaparina/administração & dosagem , Enoxaparina/efeitos adversos , Enoxaparina/economia , Feminino , Humanos , Síndrome do Intestino Irritável/cirurgia , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/mortalidade , Complicações Pós-Operatórias/prevenção & controle , Tromboembolia Venosa/etiologia , Tromboembolia Venosa/mortalidade , Tromboembolia Venosa/prevenção & controle
4.
J Surg Res ; 244: 1-8, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31279258

RESUMO

BACKGROUND: The pathophysiology behind the subacute but persistent hypercoagulable state after traumatic brain injury (TBI) is poorly understood but contributes to morbidity induced by venous thromboembolism. Because platelets and their microvesicles have been hypothesized to play a role in post-traumatic hypercoagulability, administration of commonly used agents may ameliorate this coagulability. We hypothesized that utilization of aspirin, ketorolac, amitriptyline, unfractionated heparin, or enoxaparin would modulate the platelet aggregation response after TBI. METHODS: Concussive TBI was induced by weight drop. Mice were then randomized to receive aspirin, ketorolac, amitriptyline, heparin, enoxaparin, or saline control at 2 and 8 h after TBI. Mice were sacrificed at 6 or 24 h after injury to determine coagulability by rotational thromboelastometry (ROTEM), platelet function testing with impedance aggregometry, and microvesicle enumeration. Platelet sphingolipid metabolites were analyzed by mass spectrometry. RESULTS: ROTEM demonstrated increased platelet contribution to maximum clot firmness at 6 h after TBI in mice that received aspirin or amitriptyline, but this did not persist at 24 h. By contrast, adenosine diphosphate- and arachidonic acid-induced platelet aggregation at 6 h was significantly lower in mice receiving ketorolac, aspirin, and amitriptyline compared with mice receiving saline at 6 h after injury and only arachidonic acid-initiated platelet aggregation was decreased by aspirin at 24 h. There were no differences in microvesicle production at either time point. Platelet sphingosine-1-phosphate levels were decreased at 6 h in the group receiving amitriptyline and increased at 24 h along with platelet ceramide levels at 24 h in the amitriptyline group. CONCLUSION: After TBI, amitriptyline decreased platelet aggregability and increased contribution to clot in a manner similar to aspirin. The amitriptyline effects on platelet function and sphingolipid metabolites may represent a possible role of the acid sphingomyelinase in the hypercoagulability observed after injury. In addition, inhibition of platelet reactivity may be an underappreciated benefit of low molecular weight heparins, such as enoxaparin.


Assuntos
Lesões Encefálicas Traumáticas/complicações , Inibidores da Agregação de Plaquetas/administração & dosagem , Tromboembolia Venosa/prevenção & controle , Amitriptilina/administração & dosagem , Animais , Aspirina/administração & dosagem , Coagulação Sanguínea/efeitos dos fármacos , Lesões Encefálicas Traumáticas/sangue , Lesões Encefálicas Traumáticas/fisiopatologia , Modelos Animais de Doenças , Enoxaparina/administração & dosagem , Humanos , Metabolismo dos Lipídeos/efeitos dos fármacos , Masculino , Camundongos , Agregação Plaquetária/efeitos dos fármacos , Agregação Plaquetária/fisiologia , Testes de Função Plaquetária , Esfingolipídeos/metabolismo , Tromboelastografia , Tromboembolia Venosa/sangue , Tromboembolia Venosa/etiologia
5.
Am J Health Syst Pharm ; 76(11): 815-819, 2019 May 17.
Artigo em Inglês | MEDLINE | ID: mdl-31361813

RESUMO

PURPOSE: The study analyzes the effectiveness and safety of a higher than standard enoxaparin dosing protocol implemented for pediatric patients requiring initiation of therapeutic anticoagulation. METHODS: A retrospective review of 2 enoxaparin dosing and monitoring protocols was performed. The standard protocol used 1.5 mg/kg/dose (in patients <3 months of age) and 1 mg/kg/dose (in patients ≥3 months of age) with anti-Xa monitoring following the first dose. The high-dose protocol was implemented at 1.7 mg/kg/dose (in patients <3 months of age), 1.5 mg/kg/dose (in patients 3 through 11 months of age), 1.2 mg/kg/dose (in patients 1 through 4 years of age), and 1.1 mg/kg/dose (in patients 5 through 17 years of age), with anti-Xa monitoring after the second dose. Primary outcomes were number of dosing changes prior to and time to first target anti-Xa level. Secondary outcomes included percentage of patients with anti-Xa levels above target level. RESULTS: The median number of dose changes required to achieve a target anti-Xa level was 1 (interquartile range [IQR], 0-1.5) and 0 (IQR, 0-1) for the standard-dose (n = 87) and high-dose groups (n = 132) (p = 0.17), respectively. The median number of dose adjustments to achieve target anti-Xa levels in the 3 through 11 months of age subgroup declined from 2 (IQR, 1-3.25) to 0 (IQR, 0-1) in the standard- versus high-dose groups, respectively (p < 0.01). No difference was seen in other age subgroups. Patients with above-target levels did not differ statistically between groups. CONCLUSION: Initiating enoxaparin at higher doses in pediatric patients may result in fewer dosing changes than standard dosing. Benefit was demonstrated for the 3-11 months of age high-dose subgroup. Across all groups, the high-dose strategy was safe and did not result in a statistically significant increase in above-target levels.


Assuntos
Monitoramento de Medicamentos/métodos , Enoxaparina/administração & dosagem , Inibidores do Fator Xa/administração & dosagem , Adolescente , Coagulação Sanguínea/efeitos dos fármacos , Criança , Pré-Escolar , Relação Dose-Resposta a Droga , Enoxaparina/efeitos adversos , Enoxaparina/sangue , Inibidores do Fator Xa/efeitos adversos , Inibidores do Fator Xa/sangue , Feminino , Hospitais Pediátricos/estatística & dados numéricos , Humanos , Lactente , Masculino , Estudos Retrospectivos
6.
World J Surg Oncol ; 17(1): 110, 2019 Jun 27.
Artigo em Inglês | MEDLINE | ID: mdl-31248419

RESUMO

BACKGROUND: Pharmacological thromboprophylaxis after colorectal cancer (CRC) surgery is internationally recommended for venous thromboembolism (VTE) prevention. The aim of this retrospective study was to evaluate the risk factors of postoperative bleeding after elective surgery for patients with primary CRC receiving pharmacological thromboprophylaxis of fondaparinux or enoxaparin. METHODS: We experienced consecutive 266 patients who underwent elective surgery for CRC during the study period. Finally, the medical records of 218 patients with CRC administrated fondaparinux or enoxaparin following surgery were retrospectively reviewed to evaluate symptomatic VTE until 28 days and postoperative bleeding comparing perioperative D-dimer levels. RESULTS: The significant differences in TNM classification staging and type of thromboprophylaxis were observed between postoperative bleeding-negative and bleeding-positive group. There was no statistical significance among other backgrounds of patients between the two groups. One case (0.46%) of symptomatic VTE and total 11 cases (5%) of postoperative bleeding were observed. In the univariate analysis, fondaparinux thromboprophylaxis and early disease-stage CRC (stages 0 and I) were associated with risk for postoperative bleeding. Multivariate analysis revealed that fondaparinux thromboprophylaxis was identified as an independent risk factor of postoperative bleeding. Moreover, preoperative levels of D-dimer in patients with stage IV CRC were significantly higher than those with the other stages. The significant elevation in preoperative D-dimer was also observed in patients with stage II CRC compared to those with stage I CRC. Perioperative levels of D-dimer in patients with advanced disease-stage CRC (stages II, III, and IV) were significantly higher than those in patients with early disease-stage CRC. CONCLUSIONS: Fondaparinux administration and early disease-stage CRC appeared to be risk factors for postoperative bleeding in patients with pharmacological thromboprophylaxis undergoing surgical treatment for CRC. Patients' hypercoagulative condition depending on disease progression of CRC might be related to the occurrence of postoperative bleeding following CRC surgery.


Assuntos
Anticoagulantes/efeitos adversos , Neoplasias Colorretais/cirurgia , Procedimentos Cirúrgicos Eletivos/efeitos adversos , Hemorragia Pós-Operatória/diagnóstico , Tromboembolia Venosa/prevenção & controle , Idoso , Anticoagulantes/administração & dosagem , Neoplasias Colorretais/patologia , Progressão da Doença , Enoxaparina/administração & dosagem , Enoxaparina/efeitos adversos , Feminino , Fondaparinux/administração & dosagem , Fondaparinux/efeitos adversos , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Hemorragia Pós-Operatória/epidemiologia , Hemorragia Pós-Operatória/etiologia , Prognóstico , Estudos Retrospectivos , Resultado do Tratamento , Tromboembolia Venosa/epidemiologia , Tromboembolia Venosa/etiologia
7.
BMC Pharmacol Toxicol ; 20(1): 27, 2019 05 07.
Artigo em Inglês | MEDLINE | ID: mdl-31064405

RESUMO

BACKGROUND: Thromboprophylaxis dosing strategies using enoxaparin in elderly patients with renal disease are limited, while dose adjustments or monitoring of anti-Xa levels are recommended. We sought to evaluate the efficacy and safety of enoxaparin 20 mg versus 30 mg subcutaneously daily by comparing anti-Xa levels, thrombosis and bleeding. METHODS: We conducted a prospective, single-blinded, single-center randomized clinical trial including non-surgical patients, 70 years of age or older, with renal disease requiring thromboprophylaxis. Patients were randomized to receive either 20 mg or 30 mg of enoxaparin. The primary endpoint was peak anti-Xa levels on day 3. Secondary endpoints included trough anti-Xa levels on day 3, achievement of within range prophylactic target peak anti-Xa levels and the occurrence of hemorrhage, thrombosis, thrombocytopenia or hyperkalemia during hospitalization. RESULTS: Thirty-two patients were recruited and sixteen patients were randomized to each arm. Mean peak anti-Xa level was significantly higher in 30 mg arm (n = 13) compared to the 20 mg arm (n = 11) 0.26 ± 0.11, 95%CI (0.18-0.34), versus 0.14 ± 0.09, 95CI (0.08-0.19) UI/ml, respectively; p = 0.004. Mean trough anti-Xa level was higher in 30 mg arm (n = 10) compared to the 20 mg arm (n = 16), 0.06 ± 0.03, 95CI (0.04-0.08) versus 0.03 ± 0.03, 95CI (0.01-0.05) UI/ml, respectively; p = 0.044. Bleeding events reported in the 30 mg arm were one retroperitoneal bleed requiring multiple transfusions, and in the 20 mg arm one hematuria. No thrombotic events were reported. CONCLUSION: Peak anti-Xa levels provided by enoxaparin 20 mg were lower than the desired range for thromboprophylaxis in comparison to enoxaparin 30 mg. TRIAL REGISTRATION: The trial was retrospectively registered on ClinicalTrials.gov identifier: NCT03158792 . Registered: May 18, 2017.


Assuntos
Anticoagulantes/administração & dosagem , Enoxaparina/administração & dosagem , Fator Xa/análise , Insuficiência Renal/tratamento farmacológico , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/efeitos adversos , Enoxaparina/efeitos adversos , Feminino , Hemorragia/induzido quimicamente , Humanos , Masculino , Insuficiência Renal/sangue , Método Simples-Cego , Trombose/prevenção & controle , Resultado do Tratamento
8.
Anticancer Res ; 39(5): 2615-2625, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-31092460

RESUMO

BACKGROUND/AIM: This study aimed to assess whether low-molecular-weight heparin (LMWH) is effective and safe in preventing postoperative venous thromboembolism (VTE) in patients undergoing esophageal cancer surgery. PATIENTS AND METHODS: In this single-institution, prospective, randomized trial, 73 patients with esophageal cancer undergoing esophagectomy were randomly divided into the enoxaparin group (E group) and intermittent pneumatic compression group (I group). The primary endpoint was efficacy of enoxaparin, and secondary endpoints were evidence of bleeding and serum anti-Xa activity in the E group. RESULTS: The E group comprised 42 patients and the I group comprised 31 patients. Deep vein thrombosis was observed in 0 (0%) patients in the E group and 7 (22.6%) patients in the I group (p=0.002). Soluble fibrin monomer complex was significantly lower in the E versus I group on day 8 (p<0.001). D-dimer was significantly lower in the E versus I group on days 2, 8, and 15 (p=0.008, p<0.001, p<0.001, respectively). CONCLUSION: VTE was significantly reduced by using enoxaparin.


Assuntos
Enoxaparina/administração & dosagem , Neoplasias Esofágicas/complicações , Esofagectomia/efeitos adversos , Tromboembolia Venosa/tratamento farmacológico , Idoso , Neoplasias Esofágicas/patologia , Neoplasias Esofágicas/cirurgia , Feminino , Hemorragia/tratamento farmacológico , Hemorragia/etiologia , Hemorragia/patologia , Heparina de Baixo Peso Molecular , Humanos , Masculino , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Complicações Pós-Operatórias , Tromboembolia Venosa/etiologia , Trombose Venosa/diagnóstico , Trombose Venosa/patologia , Trombose Venosa/prevenção & controle
9.
Pediatr Blood Cancer ; 66(6): e27719, 2019 06.
Artigo em Inglês | MEDLINE | ID: mdl-30900794

RESUMO

Asparaginase therapy induces a transient antithrombin III (ATIII) deficiency, which contributes to the risk of asparaginase-induced thrombosis. At Cincinnati Children's Hospital Medical Center, management of asparaginase-induced thrombosis includes ATIII supplementation during therapeutic anticoagulation with enoxaparin. Due to the expense associated with ATIII, a capped dosing approach for ATIII was evaluated in this population. Peak ATIII levels were obtained following capped doses to evaluate response. In this pilot evaluation, 11 patients received a total of 138 capped doses for a total cost savings of $803 782. This pilot evaluation represents the first reported analysis of capped ATIII dosing in oncology patients.


Assuntos
Deficiência de Antitrombina III/tratamento farmacológico , Deficiência de Antitrombina III/economia , Antitrombina III/economia , Asparaginase/efeitos adversos , Análise Custo-Benefício , Enoxaparina/economia , Trombose/tratamento farmacológico , Adolescente , Adulto , Anticoagulantes/administração & dosagem , Anticoagulantes/economia , Antitrombina III/administração & dosagem , Antitrombina III/metabolismo , Deficiência de Antitrombina III/induzido quimicamente , Criança , Quimioterapia Combinada , Enoxaparina/administração & dosagem , Feminino , Seguimentos , Humanos , Masculino , Projetos Piloto , Prognóstico , Estudos Retrospectivos , Trombose/enzimologia , Trombose/patologia , Adulto Jovem
10.
AAPS PharmSciTech ; 20(3): 140, 2019 Mar 12.
Artigo em Inglês | MEDLINE | ID: mdl-30868291

RESUMO

Facilitating utility of prior knowledge to accelerate evidence-based new drug development is a focus of several communities of knowledge, such as clinical pharmacology. For example, progress has been made via modeling and simulation of pharmacokinetic and pharmacodynamic relationships in the more effective use of "End of Phase 2" regulatory meetings for a New Drug Application (NDA). Facilitating utility of prior "Chemistry, Manufacturing, and Controls" (CMC) knowledge to accelerate new drug development and regulatory review process is also a topic of significant interest. This paper focuses on facilitating the utility of prior pharmaceutical formulation knowledge to accelerate drug product development and regulatory review of generic and biosimilar products. This knowledge is described as New Prior Knowledge (NPK) because research is often needed to fill ontological (i.e., the domain of connectivity between concepts and phenomena), epistemological (i.e., distinguishing knowledge or justified belief from the opinion), and methodological gaps in information derived a decade or so ago. The corporate economic advantages of such knowledge are derived, in part, when significant portions remain a trade secret. The proposed NPK seeks to generate knowledge about critical aspects of pharmaceutical quality and failure modes to place it in the public domain and to facilitate accelerated and more confident development and regulatory review of generic products. The paradoxical combination of "new" and "prior knowledge" is chosen deliberately to highlight both a distinction from proprietary and trade secret information and to acknowledge certain historical dogmas inherent in the current practices. Considerations for operationalizing NPK are also summarized.


Assuntos
Preparações Farmacêuticas , Equivalência Terapêutica , Administração Intranasal , Medicamentos Biossimilares , Desenvolvimento de Medicamentos , Medicamentos Genéricos , Enoxaparina/administração & dosagem , Humanos , Furoato de Mometasona/administração & dosagem , Tiroxina/administração & dosagem
11.
Burns ; 45(4): 818-824, 2019 06.
Artigo em Inglês | MEDLINE | ID: mdl-30827851

RESUMO

INTRODUCTION: Patients recovering from burn injury are at high risk of developing deep venous thrombosis (DVT). While 30-mg twice-daily enoxaparin is accepted as the standard prophylactic dose, recent evidence in injured patients suggests this dosing strategy may result in sub-optimal pharmacologic DVT prophylaxis. We hypothesized that standard enoxaparin dosing would result in inadequate DVT prophylaxis in burn patients. METHODS: A retrospective review of an ABA-verified Burn center's registry from January 2012 - December 2016 identified patients with peak plasma anti-Xa levels to monitor the efficacy of pharmacologic DVT prophylaxis. Patients ≥18 years old were included if they received at least 3 doses of enoxaparin and had appropriately timed peak anti-Xa levels. We analyzed data including patient demographics, body weight, body mass index (BMI) and total body surface area burn (TBSA). Diagnosis of DVT was collected. RESULTS: During the study period, 393 patients were screened with a plasma anti-Xa levels. Of the 157 patients that met inclusion criteria, 81 (51.6%) achieved target peak plasma anti-Xa levels (0.2-0.4 IU/mL) on standard 30-mg twice-daily prophylactic enoxaparin and 76 (48.4%) had sub-prophylactic levels. Sub-prophylactic patients were more likely to be male, have increased body weight and elevated BMI. 49 of the 76 sub-prophylactic patients received a dose-adjustment in order to reach target anti-Xa levels; 37 patients required 40mg twice-daily, 10 required 50mg twice-daily and 2 required 60mg twice-daily. The overall DVT rate was 3.8%. CONCLUSIONS: The current recommended prophylactic dose of 30-mg twice-daily enoxaparin is inadequate in many burn patients. Alternate dosing strategies should be considered to increase the number of burn patients achieving target prophylactic anti-Xa levels. Determining whether prophylactic enoxaparin dose adjustment decreases DVT rates in burn injured patients should be evaluated in future prospective trials.


Assuntos
Anticoagulantes/administração & dosagem , Queimaduras/terapia , Enoxaparina/administração & dosagem , Fator Xa/metabolismo , Trombose Venosa/prevenção & controle , Adulto , Idoso , Testes de Coagulação Sanguínea , Índice de Massa Corporal , Peso Corporal , Queimaduras/sangue , Quimioprevenção , Relação Dose-Resposta a Droga , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Fatores Sexuais , Trombose Venosa/sangue , Adulto Jovem
13.
A A Pract ; 13(1): 23-26, 2019 Jul 01.
Artigo em Inglês | MEDLINE | ID: mdl-30730309

RESUMO

A 71-year-old man with advanced vocal cord carcinoma presented with severe airway obstruction. Therapeutic anticoagulation with enoxaparin complicated management. Failure of an oral awake bronchoscopic intubation was rescued by passing a guidewire through the working channel and threading an Arndt exchange catheter into the trachea under videoscopic vision. Ventilation with the Ventrain device lasting 40 minutes (15 L/min, inspiration/expiration 1:1, 15 breaths/min), during IV anesthesia with muscle paralysis, resulted in excellent blood gas values until placement of the tracheal cannula. This case report highlights the effectiveness of a novel ventilation technique that should be considered as back-up when bronchoscopic intubation fails.


Assuntos
Obstrução das Vias Respiratórias/terapia , Enoxaparina/administração & dosagem , Intubação Intratraqueal/instrumentação , Idoso , Obstrução das Vias Respiratórias/etiologia , Broncoscopia , Cateteres , Humanos , Neoplasias Laríngeas/complicações , Masculino , Respiração Artificial/instrumentação , Prega Vocal/patologia , Vigília
14.
Med. clín (Ed. impr.) ; 152(3): 90-97, feb. 2019. graf, tab
Artigo em Espanhol | IBECS | ID: ibc-181864

RESUMO

Antecedentes y objetivos: Los programas de ahorro de transfusión disminuyen el consumo de concentrados de hematíes en cirugía protésica. Se evalúa la efectividad de un protocolo basado en el Consenso de Sevilla en la disminución de la tasa transfusional y se propone una ecuación predictiva en cirugía de rodilla. Pacientes y métodos: Estudio de cohortes en pacientes sometidos a prótesis de rodilla y cadera en 2014 y 2015 en el Hospital Comarcal de l'Alt Penedès (HCAP). Pacientes con hemoglobina (Hb) entre 10 y 13g/dl se clasificaron en anemia con o sin déficit de hierro y recibieron hierro o combinación de hierro y eritropoyetina. El día de la cirugía se administró ácido tranexámico, al día siguiente se midió la caída de Hb y durante su estancia los requerimientos y el dintel transfusional. Resultados: El estudio incluyó 334 pacientes. El protocolo disminuyó la tasa de transfusión del 41,5 al 14,8%. En cirugía de cadera los pacientes transfundidos fueron mayores, con mayor porcentaje de comorbilidad y uso de anticoagulantes y menor Hb preoperatoria. El ácido tranexámico no se asoció a disminución del sangrado. En cirugía de rodilla, el análisis multivariante mostró que la administración de ácido tranexámico fue la variable que más disminuyó el riesgo de transfusión, seguido de valores de Hb preoperatoria más altos. La ecuación resultante predice la tasa transfusional, con una sensibilidad del 55% y una especificidad del 95,7%. Conclusión: La implantación del programa disminuyó la tasa transfusional. La efectividad de ácido tranexámico varía según la artroplastia. El uso conjunto de hierro y eritropoyetina recombinante humana es necesario para mejorar la Hb


Background and objectives: Patient blood management in orthopaedic surgery reduces transfusion risk. The best protocol is unknown. The effectiveness of a protocol based on the Seville Consensus on the reduction of transfusion risk is evaluated and a predictive transfusion equation is proposed in knee surgery. Patients and methods: Cohort study in patients undergoing knee and hip arthroplasty from January 2014 to December 2015 at a second level complexity hospital in Vilafranca del Penedès (Barcelona). Patients with Hb between 10 and 13g/dL were classified as anaemic with or without iron deficiency and received iron or combination of iron and erythropoietin. On the day of surgery, tranexamic acid was administered, the Hb drop was measured the next day and the requirements and the transfusion lintel were measured during the stay. Results: A total of 334 patients were included in the study. The implementation of the programme decreased the transfusion risk from 41.5% to 14.8% at the end of the study. In hip surgery, transfused patients were significantly older, sicker and with lower preoperative Hb. Tranexamic acid did not decrease bleeding. In knee surgery, the administration of tranexamic acid was the variable that most decreased the transfusion risk followed by a high preoperative Hb. The equation predicts transfusion risk with a sensitivity of 55% and specificity of 95.7%. Conclusion: The implementation of the programme reduces transfusion risk. The effectiveness of tranexamic acid varies according to surgery site. The use of iron and recombinant human erythropoietin is necessary to improve Hb


Assuntos
Humanos , Resultado do Tratamento , Transfusão de Eritrócitos , Estudos de Coortes , Prótese do Joelho , Prótese de Quadril , Avaliação de Eficácia-Efetividade de Intervenções , Anemia/complicações , Anemia/tratamento farmacológico , Ácido Tranexâmico/administração & dosagem , Enoxaparina/administração & dosagem
15.
Thromb Haemost ; 119(3): 461-466, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30650446

RESUMO

The double-blind, randomized, AMPLIFY trial compared 6 months' treatment with apixaban (10 mg twice daily for 7 days and 5 mg twice daily thereafter) versus conventional treatment (subcutaneous enoxaparin [1 mg/kg twice daily for ≥ 5 days] overlapped and followed by warfarin [international normalized ratio = 2.0-3.0]) in patients with acute venous thromboembolism (VTE). This post hoc analysis of AMPLIFY compared outcomes among those taking or not taking concomitant anti-platelet therapy. The primary efficacy outcome was recurrent VTE or VTE-related death; the principal safety outcome was major bleeding. Of 5,365 (apixaban, n = 2,676; enoxaparin/warfarin, n = 2,689) randomized patients, 813 (apixaban, n = 402 [15%]; enoxaparin/warfarin, n = 411 [15%]) took concomitant anti-platelet therapy, of which 92% consisted of low-dose aspirin. Rates of VTE or VTE-related death were similar whether or not anti-platelet agents were taken (apixaban: 3.6 and 2.0%; enoxaparin/warfarin: 3.0 and 2.6%; anti-platelet use: relative risk [RR], 1.23; 95% confidence interval [CI], 0.58-2.62; no anti-platelet use: RR, 0.77; 95% CI, 0.52-1.13); interaction p-value = 0.299. Major bleeding rates were threefold higher in those taking versus those not taking anti-platelet agents (apixaban: 1.2 and 0.4%; enoxaparin/warfarin: 4.1 and 1.4%; anti-platelet use: RR, 0.30; 95% CI, 0.11-0.81; no anti-platelet use: RR, 0.31; 95% CI, 0.15-0.63); interaction p-value = 0.924. Concomitant anti-platelet therapy produced a proportionally similar increase in major bleeding in patients randomized to apixaban or conventional therapy, but there were fewer major bleeds with apixaban. Therefore, the overall safety of apixaban over conventional therapy was maintained in patients receiving anti-platelet therapy. Clinicaltrials.gov: NCT00643201.


Assuntos
Anticoagulantes/administração & dosagem , Enoxaparina/administração & dosagem , Inibidores do Fator Xa/administração & dosagem , Inibidores da Agregação de Plaquetas/administração & dosagem , Pirazóis/administração & dosagem , Piridonas/administração & dosagem , Tromboembolia Venosa/tratamento farmacológico , Varfarina/administração & dosagem , Adulto , Idoso , Anticoagulantes/efeitos adversos , Método Duplo-Cego , Esquema de Medicação , Enoxaparina/efeitos adversos , Inibidores do Fator Xa/efeitos adversos , Feminino , Hemorragia/induzido quimicamente , Humanos , Masculino , Pessoa de Meia-Idade , Inibidores da Agregação de Plaquetas/efeitos adversos , Pirazóis/efeitos adversos , Piridonas/efeitos adversos , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Tromboembolia Venosa/sangue , Tromboembolia Venosa/diagnóstico , Tromboembolia Venosa/mortalidade , Varfarina/efeitos adversos
16.
Int J Gynaecol Obstet ; 145(1): 70-75, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30671924

RESUMO

OBJECTIVE: To assess the efficacy and safety of anti-Xa guided dose-adjusted low molecular weight heparin (LMWH) thromboprophylaxis in at-risk pregnant women. METHODS: This single-center retrospective study was conducted at a quaternary hospital in Johannesburg, South Africa. We analyzed clinical and laboratory data for pregnant patients referred between January 1, 1999, and May 1, 2017, with an increased risk of venous thromboembolic disease (VTED) and treated with prophylactic LMWH adjusted according to anti-Xa levels. The efficacy endpoint was pregnancy-related VTED and/or pregnancy loss despite anti-Xa guided dose-adjusted LMWH thromboprophylaxis. RESULTS: We reviewed data for 113 consecutive pregnant patients with 151 pregnancies referred for prophylactic LMWH. Prevalence of pregnancy-related VTED was 1.3% (95% confidence interval [CI] 0.1-4.7), which is lower than that reported in the literature for fixed-dose thromboprophylaxis in similar at-risk groups. One venous thromboembolism event occurred in the antenatal period (despite adequate prophylaxis) and the second in the postpartum period (related to prolonged labor). Prevalence of pregnancy-related bleeding was 2% (95% CI 0.4-5.7) with all bleeding events considered to be minor and unrelated to LMWH therapy. CONCLUSION: This study demonstrated the efficacy and safety of anti-Xa dose-adjusted LMWH thromboprophylaxis in at-risk pregnant patients.


Assuntos
Anticoagulantes/administração & dosagem , Enoxaparina/administração & dosagem , Tromboembolia Venosa/prevenção & controle , Adulto , Relação Dose-Resposta a Droga , Feminino , Humanos , Hemorragia Pós-Parto/prevenção & controle , Período Pós-Parto , Gravidez , Prevalência , Estudos Retrospectivos , Fatores de Risco , África do Sul
17.
Int J Lab Hematol ; 41(3): 309-315, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-30698331

RESUMO

INTRODUCTION: Co-administration of enoxaparin and a direct oral factor Xa inhibitor (xabans: apixaban, edoxaban, rivaroxaban) could give rise to the problem of overlapping the anti-Xa activity when measuring direct oral anticoagulant (DOAC) levels. We aimed to evaluate in vitro the degree of the interference of increasing enoxaparin concentrations on xaban plasma levels measured by different chromogenic anti-Xa assays with drug-specific calibrators and controls. METHODS: Seven plasma samples were spiked with apixaban, edoxaban, or rivaroxaban at fixed concentration, and enoxaparin at increasing concentrations (0, 0.125, 0.250, 0.50, 1.0, 1.50, and 2.0 IU/mL). The evaluated chromogenic assays were as follows: Biophen DiXaI and Biophen Heparin LRT (Hyphen BioMed), Berichrom Heparin and Innovance Heparin (Siemens), STA-Liquid Anti-Xa (Stago Diagnostics), Technochrom anti-Xa (Technoclone), and HemosIL Liquid Anti-Xa (Werfen). RESULTS: The presence of enoxaparin caused increased DOAC levels, with over-estimation depending on the anti-Xa assay and on the heparin concentration in the sample. The smallest over-estimation was in the sample with enoxaparin 0.125 IU/mL and the greatest in the sample with enoxaparin 2.0 IU/mL (0%, 3.1%, and 7.4% vs 583.8%, 526.1%, and 415.2% for apixaban, edoxaban, and rivaroxaban, respectively). Biophen DiXaI showed lower interference compared to other methods (maximum over-estimation in the presence of enoxaparin 2.0 IU/mL: 56.4% dosing rivaroxaban by Biophen DIXaI vs 583.8% dosing apixaban by Berichrom Heparin). CONCLUSION: The presence of enoxaparin interferes with xabans measurement by chromogenic anti-Xa assays causing falsely elevated DOAC levels, the over-estimation being dependent on the anti-Xa assay and on the heparin concentration in the sample.


Assuntos
Testes de Coagulação Sanguínea/métodos , Enoxaparina/farmacocinética , Inibidores do Fator Xa/farmacocinética , Técnicas In Vitro , Enoxaparina/administração & dosagem , Inibidores do Fator Xa/administração & dosagem , Humanos
18.
Thromb Haemost ; 119(1): 87-91, 2019 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-30597503

RESUMO

OBJECTIVE: Randomized trials showed no improvement in pregnancy outcomes with the use of low molecular weight heparin (LMWH) to prevent placenta-mediated pregnancy complications (PMPCs) among thrombophilic women. However, the effect of treatment on placental findings was not examined. We aimed to examine the occurrence of placental vascular lesions in thrombophilic women treated with LMWH dose adjusted according to anti-factor Xa compared with a fixed dose. STUDY DESIGN: This study was a secondary analysis of a randomized trial designed to examine whether LMWH dose adjusted according to anti-factor Xa levels compared with a fixed dose would reduce the risk of PMPC. Eligible women were randomly allocated in a 1:1 ratio to either a fixed dose of 40 mg daily LMWH (fixed dose group) or adjusted dose according to anti-factor Xa levels (adjusted dose group). Placentas were examined by the same perinatal pathologist who was blinded to group allocation. The primary outcome for this analysis was the incidence of maternal placental vascular lesions. RESULTS: During the study period, 88 placentas were examined; 41 and 47 from the fixed and adjusted dose groups, respectively. Demographics, obstetrics and types of thrombophilias were similar between the groups. Maternal placental vascular lesions were observed in 23 (56.1%) and 21 (44.68%) placentas (p = 0.28) and foetal placental vascular lesions in 2 (4.88%) and 1 (2.13%) placentas (p = 0.59) in the fixed and adjusted groups, respectively. CONCLUSION: Adjusted dose of enoxaparin according to anti-factor Xa levels compared with a fixed dose did not affect placental vascular lesions in thrombophilic women.


Assuntos
Enoxaparina/administração & dosagem , Placenta/efeitos dos fármacos , Trombofilia/tratamento farmacológico , Adolescente , Adulto , Anticoagulantes/uso terapêutico , Interpretação Estatística de Dados , Esquema de Medicação , Fator Xa/análise , Inibidores do Fator Xa/uso terapêutico , Feminino , Heparina de Baixo Peso Molecular/uso terapêutico , Humanos , Pessoa de Meia-Idade , Obstetrícia , Placenta/patologia , Gravidez , Complicações Cardiovasculares na Gravidez/prevenção & controle , Resultado da Gravidez , Tromboembolia Venosa/prevenção & controle , Adulto Jovem
19.
Rev. esp. anestesiol. reanim ; 66(1): 37-45, ene. 2019. ilus, tab
Artigo em Espanhol | IBECS | ID: ibc-177288

RESUMO

La insuficiencia cardiaca constituye un cuadro sindrómico de elevada incidencia en la medicina actual. Cuando los síntomas de la insuficiencia cardiaca progresan y se convierten en refractarios, la indicación de trasplante cardiaco es la mejor opción terapéutica. Sin embargo, debido a la escasez de donantes y a las largas listas de espera, muchos de estos pacientes necesitan la implantación de dispositivos de asistencia ventricular como puente a este trasplante, o en algunos casos, cuando el trasplante no es una opción, como terapia definitiva. En este artículo se presenta una serie de 4 casos clínicos en pacientes portadores de dispositivos de asistencia ventricular que precisaron intervención quirúrgica. Tres de ellos estaban asistidos con asistencias de larga duración: 2 EXCOR (pulsátiles y paracorpórea) y un HEARTWARE (no pulsátil e intracorpórea) y el último con una asistencia de corta duración; CentriMag Levitronix biventricular. No existe bibliografía significativa sobre las implicaciones perioperatorias de estos pacientes cuando son sometidos a cirugía urgente o programada. La experiencia en nuestro centro nos lleva a plantear la necesidad de conocer una serie de aspectos: funcionamiento de cada dispositivo, recalcando la correcta colocación de las cánulas durante la cirugía; el manejo apropiado de la medicación, recalcando la importancia de las terapias anticoagulantes y antiagregantes; los cambios fisiopatológicos a nivel cardiopulmonar debidos a la implantación de estos dispositivos; y la importancia de la administración de una correcta antibioterapia. Ante la complejidad que presentan estos casos, la escasa experiencia en este campo y los pocos casos que existen de estas situaciones se recomienda la creación de protocolos para garantizar un manejo correcto de estos


Heart failure (HF) is a syndromic condition with a high incidence in current medicine. When the symptoms of HF progress, and become refractory, cardiac transplant is the best therapeutic option. However, due to the shortage of donors and the long waiting lists, many of those patients are candidates for implantation of ventricular assist devices as a bridge to the cardiac transplant, or when this is not an option, as a definitive therapy. A series of four clinical cases of patients with ventricular assist devices that required surgical intervention, is presented. Three of them were assisted with long-term care: two EXCOR (pulsatile and para-corporeal) and one HEARTWARE (non-pulsatile and intra-corporeal), and the last one with short-term assistance; CentriMag biventricular Levitronix. There is no significant literature on the peri-operative implications of these patients when they undergo urgent or scheduled surgery. The experience in our centre leads us to raise the need to determine a series of aspects: operation of each device, emphasising the correct placement of the cannulas during the surgery; the proper management of any medication, emphasising the importance of anticoagulant and anti-platelet therapies; the Pathophysiological changes at cardiopulmonary level due to the implantation of these devices; and the importance of the administration of a correct antibiotic therapy. Given the complexity of these cases, the limited experience in this field, and the few cases that exist in these situations, it is recommended to create protocols to ensure their proper management


Assuntos
Humanos , Masculino , Adulto , Pessoa de Meia-Idade , Idoso , Anestesia Geral/métodos , Apendicectomia/métodos , Enoxaparina/administração & dosagem , Colecistectomia/métodos , Inibidores da Agregação de Plaquetas/administração & dosagem , Acenocumarol/administração & dosagem , Falha de Prótese , Craniotomia/métodos , Disfunção Ventricular Esquerda/complicações , Coração Auxiliar
20.
World Neurosurg ; 123: e25-e30, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30528524

RESUMO

OBJECTIVE: Anticoagulant therapy (ACT) after traumatic intracranial hemorrhage may lead to progression of hemorrhage, but in the presence of thromboembolic events, the clinician must decide if the benefits outweigh the risks. Currently, no data exist to guide therapy in the acute setting. METHODS: We retrospectively identified all patients admitted to our institution with traumatic intracranial hemorrhage that received intravenous heparin, full-dose enoxaparin, or warfarin during their initial hospitalization over a 3-year period. We reviewed their demographics, hospital course, clinical indication and timing for initiation of ACT, and complications. RESULTS: A total of 112 patients were identified. The median age and Glasgow Coma Scale score of these patients was 50.5 years and 9.5, respectively. Twenty-two patients required neurosurgical procedures for their presenting injury, including intracranial pressure monitors and/or open surgeries. Fifty-four patients had deep vein thrombosis or pulmonary embolism prior to initiation, and the remaining 20 patients had preexisting conditions or other indications for initiating ACT. The median time from injury to starting ACT was 8 days. Immediate complications occurred in 6 patients; however, none of these patients required a neurosurgical intervention. Delayed complications included progression of acute to chronic subdural hematoma that required intervention in 2 patients. One patient died from delayed hemorrhage. CONCLUSIONS: For this patient population, the risk of immediate and delayed intracranial hemorrhages from initiating ACT therapy in intracranial injury must be weighed against the morbidity of delaying treatment. Although further studies are needed, our review provides the first rates of complications for this patient population.


Assuntos
Anticoagulantes/administração & dosagem , Hemorragia Intracraniana Traumática/tratamento farmacológico , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Enoxaparina/administração & dosagem , Feminino , Heparina/administração & dosagem , Humanos , Hemorragia Intracraniana Traumática/cirurgia , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Resultado do Tratamento , Varfarina/administração & dosagem , Adulto Jovem
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