RESUMO
Direct oral anticoagulants (DOAC) are the most widely prescribed oral anticoagulants in the United States. Despite advantages over warfarin, system-level improvements are needed to optimize outcomes. While Veterans Health Administration and others have described successful DOAC management dashboard implementation, the extent of use nationally is unknown. A survey of Anticoagulation Forum's members was conducted to assess access to digital tools available within a dashboard and to describe implementation models. An Expert Forum was subsequently convened to identify barriers to dashboard development and adoption. Responses were received from 340 targeted recipients (8.5% of invitees). Only a minority of inpatient (25/52, 48.1%) and outpatient (47/133, 35.3%) respondents outside of Veterans Health Administration were able to generate rosters of DOAC users on-demand, and fewer had the ability to digitally display key clinical data elements, identify drug-related problems, document interventions, or generate reports. The lack of regulatory requirements regarding Anticoagulation Stewardship was identified by the Expert Forum as the major barrier to widespread development of digital tools for improved anticoagulation management. While some health systems have demonstrated the feasibility of DOAC dashboards and described their impact on quality and efficiency, these tools do not appear to be widely available in the United States apart from Veterans Health Administration. The lack of regulatory requirements for Anticoagulation Stewardship may be the primary barrier to the development of digital resources to better manage anticoagulants. Efforts to secure regulatory requirements for Anticoagulation Stewardship are needed, and evidence of improvements in clinical and financial outcomes through DOAC dashboard use will likely bolster such efforts.
Assuntos
Anticoagulantes , Fibrilação Atrial , Humanos , Estados Unidos , Anticoagulantes/uso terapêutico , Varfarina/uso terapêutico , Coagulação Sanguínea , Administração Oral , Fibrilação Atrial/tratamento farmacológicoRESUMO
Ciraparantag, an anticoagulant reversal agent, is a small molecule specifically designed to bind noncovalently by charge-charge interaction to unfractionated heparin and low-molecular-weight heparin. It shows binding characteristics that are similar to those of direct oral anticoagulants (DOACs). A dynamic light-scattering methodology was used to demonstrate ciraparantag's binding to the heparins and DOACs and its lack of binding to a variety of proteins including coagulation factors and commonly used drugs. Ciraparantag reaches maximum concentration within minutes after IV administration with a half-life of 12 to 19 minutes. It is primarily hydrolyzed by serum peptidases into 2 metabolites, neither of which has substantial activity. Ciraparantag and its metabolites are recovered almost entirely in the urine. In animal models of bleeding (rat tail transection and liver laceration), a single IV dose of ciraparantag given at peak concentrations of the anticoagulant, but before the bleeding injury, significantly reduced the blood loss. Ciraparantag, given after the bleeding injury, also significantly reduced blood loss. It appears to have substantial ability to reduce blood loss in animal models in which a variety of anticoagulants are used and has potential as a useful DOAC reversal agent.
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Arginina/análogos & derivados , Coagulação Sanguínea/efeitos dos fármacos , Hemorragia/tratamento farmacológico , Piperazinas/farmacologia , Piperazinas/farmacocinética , Animais , Anticoagulantes/efeitos adversos , Arginina/metabolismo , Arginina/farmacocinética , Arginina/farmacologia , Feminino , Meia-Vida , Hemorragia/induzido quimicamente , Humanos , Masculino , Piperazinas/metabolismo , Ratos , Ratos Sprague-DawleyRESUMO
BACKGROUND: There are very few documented reports in literature of cerebral venous sinus thrombosis (CVST) caused by immune-mediated heparin-induced thrombocytopenia (HIT). Further, there are very few reports of false negative serotonin release assays (SRAs) when testing for immune-mediated HIT. CASE PRESENTATION: We present a case of a 60- year-old male with recent unfractionated heparin administration for venous thromboembolism prophylaxis, an elevated 4T score of 5 and acute CVST in which immune-mediated HIT was suspected. The enzyme-linked immunosorbent assay (ELISA) screening assay was positive for PF4 antibodies and subsequent reflexive SRA testing was negative. However, given the clinical picture, a false-negative SRA was suspected (and eventually confirmed), prompting use of the alternative PF4-dependent p-selectin expression assay (PEA) which was confirmed to be positive. The patient was successfully managed with a bivalirudin infusion and eventually transitioned to apixaban. CONCLUSION: It is uncommon for immune-mediated HIT with thrombosis to manifest as CVST. Similarly, false-negative SRA is uncommon in immune-mediated HIT. Take-away lessons from our case report include considering HIT in CVST patients with an elevated 4T score and considering the entire clinical picture and degree of suspicion for HIT when interpreting negative HIT testing results. The PEA, in conjunction with the 4Ts score, may be considered as an alternate diagnostic assay for HIT.
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This scoping review summarizes the extent and characteristics of the published literature describing digital population management dashboards implemented to improve the quality of anticoagulant management. A standardized search protocol was executed to identify relevant manuscripts published between January 1, 2015 and May 31, 2022. The resulting records were systematically evaluated by multiple blinded reviewers and the findings from selected papers were evaluated and summarized. Twelve manuscripts were identified, originating from 5 organizations within the US and 2 from other countries. The majority (75%) described implementation in the outpatient setting. The identified papers described a variety of positive results of dashboard use, including a 24.5% reduction of questionable direct oral anticoagulant dosing in one organization, a 33.3% relative improvement in no-show appointments in an ambulatory care clinic, and a 75% improvement in intervention efficiency. One medical center achieved a 98.4% risk-appropriate venous thromboembolism risk prophylaxis prescribing rate and 40.6% reduction in anticoagulation-related adverse event rates. The manuscripts primarily described retrospective findings from single-center dashboard implementation experiences. Digital dashboards have been successfully implemented to support the anticoagulation of acute and ambulatory patients and available manuscripts suggest a positive impact on care-related processes and relevant patient outcomes. Prospective studies are needed to better characterize the implementation and impact of dashboards for anticoagulation management. Published reports suggest that digital dashboards may improve the quality, safety, and efficiency of anticoagulation management. Additional research is needed to validate these findings and to understand how best to implement these tools.
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Antithrombotic therapies include anticoagulants and antiplatelet agents. It is increasingly recognized that combined dual antithrombotic (DAT, which consists of an oral anticoagulant and a single antiplatelet) and triple antithrombotic therapies (TAT, which consists of an oral anticoagulant and two antiplatelets) increase bleeding risk. Additionally, the benefit of aspirin for primary prevention has been called into question by a number of randomized controlled trials over the last few years. As such, several recent clinical trials have explored de-escalated antithrombotic regimens that have resulted in less bleeding with similar efficacy. Our study was a retrospective, observational investigation assessing the effect of a systematic antithrombosis stewardship intervention implemented in outpatient, pharmacy-driven antithrombosis clinics on the number of patients receiving potentially inappropriate combined antithrombotic therapy. Pharmacists identified anticoagulation patients on concomitant antiplatelet therapy, assessed for appropriateness, and performed interventions if needed. Of the 875 patients included, 261 (29.8%) were on combined antithrombotic therapy, 48 (18.4%) of which were deemed inappropriate at baseline. By the end of the intervention period, 45 (93%) of these patients had a de-escalation in combined therapy (p < 0.001). We found that a systematic de-escalation protocol led to a significant reduction in patients on inappropriate combined antithrombotic therapy.
Assuntos
Fibrilação Atrial , Intervenção Coronária Percutânea , Instituições de Assistência Ambulatorial , Anticoagulantes/efeitos adversos , Fibrilação Atrial/tratamento farmacológico , Quimioterapia Combinada , Fibrinolíticos/efeitos adversos , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Inibidores da Agregação Plaquetária/uso terapêutico , Estudos RetrospectivosRESUMO
Thromboembolism is a common and deadly consequence of COVID-19 infection for hospitalized patients. Based on clinical evidence pre-dating the COVID-19 pandemic and early observational reports, expert consensus and guidance documents have strongly encouraged the use of prophylactic anticoagulation for patients hospitalized for COVID-19 infection. More recently, multiple clinical trials and larger observational studies have provided evidence for tailoring the approach to thromboprophylaxis for patients with COVID-19. This document provides updated guidance for the use of anticoagulant therapies in patients with COVID-19 from the Anticoagulation Forum, the leading North American organization of anticoagulation providers. We discuss ambulatory, in-hospital, and post-hospital thromboprophylaxis strategies as well as provide guidance for patients with thrombotic conditions who are considering COVID-19 vaccination.
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COVID-19 , Tromboembolia Venosa , Anticoagulantes/uso terapêutico , Vacinas contra COVID-19 , Humanos , Pandemias , Tromboembolia Venosa/tratamento farmacológico , Tromboembolia Venosa/etiologia , Tromboembolia Venosa/prevenção & controleRESUMO
Coronavirus disease 2019 (COVID-19) is a viral infection that can, in severe cases, result in cytokine storm, systemic inflammatory response and coagulopathy that is prognostic of poor outcomes. While some, but not all, laboratory findings appear similar to sepsis-associated disseminated intravascular coagulopathy (DIC), COVID-19- induced coagulopathy (CIC) appears to be more prothrombotic than hemorrhagic. It has been postulated that CIC may be an uncontrolled immunothrombotic response to COVID-19, and there is growing evidence of venous and arterial thromboembolic events in these critically ill patients. Clinicians around the globe are challenged with rapidly identifying reasonable diagnostic, monitoring and anticoagulant strategies to safely and effectively manage these patients. Thoughtful use of proven, evidence-based approaches must be carefully balanced with integration of rapidly emerging evidence and growing experience. The goal of this document is to provide guidance from the Anticoagulation Forum, a North American organization of anticoagulation providers, regarding use of anticoagulant therapies in patients with COVID-19. We discuss in-hospital and post-discharge venous thromboembolism (VTE) prevention, treatment of suspected but unconfirmed VTE, laboratory monitoring of COVID-19, associated anticoagulant therapies, and essential elements for optimized transitions of care specific to patients with COVID-19.
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Anticoagulantes/uso terapêutico , Infecções por Coronavirus/terapia , Pneumonia Viral/terapia , Tromboembolia Venosa/prevenção & controle , COVID-19 , Infecções por Coronavirus/complicações , Heparina/uso terapêutico , Humanos , Pandemias , Alta do Paciente , Transferência de Pacientes , Pneumonia Viral/complicações , Terapia Trombolítica , Tromboembolia Venosa/virologia , VarfarinaRESUMO
Two specific reversal agents for direct oral anticoagulants (DOACs) have been approved in the United States: idarucizumab for dabigatran reversal and andexanet alfa for apixaban and rivaroxaban reversal. Non-specific prohemostatic agents such as prothrombin complex concentrate (PCC) and activated PCC have also been used for DOAC reversal. The goal of this document is to provide comprehensive guidance from the Anticoagulation Forum, a North American organization of anticoagulation providers, regarding use of DOAC reversal agents. We discuss indications for reversal, provide guidance on how the individual reversal agents should be administered, and offer suggestions for stewardship at the health system level.
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Anticorpos Monoclonais Humanizados/uso terapêutico , Anticoagulantes/efeitos adversos , Fator Xa/uso terapêutico , Proteínas Recombinantes/uso terapêutico , Anticoagulantes/uso terapêutico , Humanos , Guias de Prática Clínica como AssuntoRESUMO
BACKGROUND: No randomized controlled trials have investigated enoxaparin once versus twice daily for venous thromboembolism (VTE) treatment in cancer patients. OBJECTIVE: To compare the safety and efficacy of enoxaparin 1 mg/kg twice daily versus enoxaparin 1.5 mg/kg/day for the treatment of acute VTE in cancer patients. METHODS: This was a single-center, retrospective, observational cohort study. Adults with active cancer and an acute VTE were included. The primary outcome evaluated was the incidence of clinically relevant (major and nonmajor) bleeding (CRB) within 30 days of enoxaparin initiation. Secondary outcomes included the incidence of CRB, thrombosis, and death at 30, 90, and 180 days. The study protocol was approved by the institutional review board. RESULTS: A total of 123 patients met inclusion criteria; 85 patients (69%) were treated with once-daily and 38 patients (31%) with twice-daily enoxaparin. CRB was numerically higher at 30 days in the twice-daily enoxaparin group compared with the once-daily group (5.3% vs 2.4%, P = 0.587). There was a nonsignificant higher incidence of CRB in the once-daily enoxaparin group compared with the twice-daily group at 90 days (8.3% vs 8%, P = 1.0) and 180 days (12.5% vs 7.1%, P = 1.0). The composite outcome of CRB, thrombosis, and death was higher at all time points with enoxaparin once daily. CONCLUSIONS: Lack of statistical power in this study precludes definitive conclusions. Clinicians may consider twice-daily enoxaparin because of potentially fewer adverse events but may be limited by patient preference and/or financial constraints.
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Anticoagulantes/administração & dosagem , Enoxaparina/administração & dosagem , Neoplasias/tratamento farmacológico , Tromboembolia Venosa/tratamento farmacológico , Doença Aguda , Idoso , Anticoagulantes/efeitos adversos , Esquema de Medicação , Enoxaparina/efeitos adversos , Feminino , Hemorragia/induzido quimicamente , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Trombose VenosaRESUMO
Published literature suggests that a fixed-dose 4-factor prothrombin complex concentrate (4FPCC) may be efficacious in managing warfarin-associated hemorrhage, however the ideal dose is still unclear. The purpose of this evaluation was to determine the efficacy of fixed-dose 4FPCC in reducing the International Normalized Ratio (INR) to ≤ 1.5 among warfarin patients with need for urgent or emergent anticoagulation reversal. Starting October 2016, our institution changed from standard 4FPCC FDA-labeled dosing based on the patient's presenting INR and weight, to a fixed-dose of 1500 units for all patients requiring urgent or emergent warfarin reversal. We conducted a retrospective evaluation, after implementation, with the primary outcome being the proportion of patients who achieved an INR ≤ 1.5 with a single fixed-dose of 1500 units of 4FPCC. Secondary outcomes assessed included: medication turnaround times, attainment of target INR ≤ 2 or clinical hemostasis (as judged by the prescribing provider), use of rescue doses, thrombotic events, and cost savings. A total of 37 patients were included in the analysis. Almost 75% of patients achieved an INR ≤ 1.5 after a single fixed dose of 1500 units, and 100% of patients achieved an INR ≤ 2. The median pre- and post-dose INRs were 3.06 and 1.32 respectively. Based on this evaluation, the administration of a fixed dose of 1500 units 4FPCC, was shown to be effective in adequately reversing the INR in the majority of patients with minimal thrombotic risks.
Assuntos
Fatores de Coagulação Sanguínea/administração & dosagem , Coeficiente Internacional Normatizado , Varfarina/uso terapêutico , Adulto , Idoso , Fatores de Coagulação Sanguínea/efeitos adversos , Fatores de Coagulação Sanguínea/economia , Fatores de Coagulação Sanguínea/uso terapêutico , Cálculos da Dosagem de Medicamento , Interações Medicamentosas , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Trombose/induzido quimicamente , Varfarina/efeitos adversosRESUMO
Emerging evidence suggests the use of peri-procedural bridging during interruptions in warfarin therapy increases bleed risk without reducing thromboembolic events. We implemented a peri-procedural anticoagulant management risk assessment tool in a single, outpatient anticoagulation clinic within an academic teaching institution. In this retrospective, pre-post observational study, we evaluated adults who required an interruption in warfarin therapy for an invasive procedure. The primary outcome was the proportion of patients who received bridging prior to and following implementation of the tool. Secondary outcomes included major bleeding, clinically relevant non-major bleeding, thromboembolic events, and other surgical complications within 30 days of the index procedure. In total, 149 patients were included. Bridging was recommended in 60% of the pre-intervention group and in 39.3% of the post-intervention group (p = 0.012). There were no significant differences in the secondary outcomes between the groups. However, patients who received bridging had numerically more bleeding events than patients who did not (12.3 vs. 3.9%, p = 0.102), and patients who received therapeutic dose bridging had more bleeding events than those who received modified dose bridging (10.9 vs. 1.4%, p = 0.466). Following implementation of the tool, there was a statistically significant decrease in the number of patients who received bridging without an increase in thromboembolic events. There were numerically higher rates of bleeding in those who received bridging. Additional research is needed to evaluate efficacy and safety of prophylactic versus treatment dose bridging and how implementation of peri-procedural antithrombotic tools reflecting the emerging evidence will affect patient outcomes, satisfaction and healthcare costs.
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Anticoagulantes/uso terapêutico , Assistência Perioperatória , Tromboembolia/prevenção & controle , Adulto , Idoso , Anticoagulantes/efeitos adversos , Feminino , Hemorragia/induzido quimicamente , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Tromboembolia/tratamento farmacológico , Resultado do Tratamento , Varfarina/efeitos adversos , Varfarina/uso terapêuticoRESUMO
BACKGROUND: Anticoagulated patients are particularly vulnerable to ADEs when they experience changes in medical acuity, pharmacotherapy, or care setting, and resources guiding care transitions are lacking. The New York State Anticoagulation Coalition convened a task force to develop a consensus list of requisite data elements (RDEs) that should accompany all anticoagulated patients undergoing care transitions. METHODS: A multidisciplinary panel of 15 anticoagulation experts voluntarily completed an iterative Delphi process. Resources were disseminated and deliberated via remote technology, with consensus achieved via blinded electronic polling. RESULTS: The panel reached consensus on a list of 15 RDEs for anticoagulation communication at discharge (the ACDC List). Consensus was rapidly achieved by the full panel on 13 elements, while 3 (2 of which were combined into 1 element) required multiple iterations and achieved consensus with votes from 8 available panelists. The elements encompassed a range of factors, including drug use and indications, previous exposure and duration of therapy, recent drug exposure and laboratory results and expectations for subsequent administration, therapy goals, patient education and comprehension, and expectations for clinical management. Twelve of the elements are applicable to any anticoagulant, and 3 are specific to warfarin. CONCLUSION: The ACDC List identifies specific pieces of clinical information that a panel of anticoagulant experts agree should be communicated to downstream providers for all anticoagulated patients undergoing care transitions. Additional study is needed to objectively evaluate the ability of existing care systems to communicate the elements and to assess possible relationships between communication of the elements and clinical outcomes.
Assuntos
Anticoagulantes/administração & dosagem , Lista de Checagem/normas , Continuidade da Assistência ao Paciente/organização & administração , Transferência de Pacientes/organização & administração , Melhoria de Qualidade/organização & administração , Anticoagulantes/efeitos adversos , Comunicação , Consenso , Técnica Delphi , Documentação/normas , Humanos , Reconciliação de Medicamentos/organização & administração , New York , Alta do Paciente , Educação de Pacientes como Assunto/normas , Segurança do Paciente , Transferência de Pacientes/normas , Guias de Prática Clínica como Assunto/normas , Desenvolvimento de Programas , Melhoria de Qualidade/normas , Qualidade da Assistência à Saúde/organização & administração , Estados UnidosRESUMO
Anticoagulant drugs are the foundation of therapy for patients with VTE. While effective therapeutic agents, anticoagulants can also result in hemorrhage and other side effects. Thus, anticoagulant therapy selection should be guided by the risks, benefits and pharmacologic characteristics of each agent for each patient. Safe use of anticoagulants requires not only an in-depth knowledge of their pharmacologic properties but also a comprehensive approach to patient management and education. This paper will summarize the key pharmacologic properties of the anticoagulant agents used in the treatment of patients with VTE.
RESUMO
Anticoagulant drugs are the foundation of therapy for patients with VTE. While effective therapeutic agents, anticoagulants can also result in hemorrhage and other side effects. Thus, anticoagulant therapy selection should be guided by the risks, benefits and pharmacologic characteristics of each agent for each patient. Safe use of anticoagulants requires not only an in-depth knowledge of their pharmacologic properties but also a comprehensive approach to patient management and education. This paper will summarize the key pharmacologic properties of the anticoagulant agents used in the treatment of patients with VTE.
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Anticoagulantes/uso terapêutico , Tromboembolia Venosa/tratamento farmacológico , Anticoagulantes/efeitos adversos , Hemorragia/induzido quimicamente , Hemorragia/prevenção & controle , HumanosRESUMO
Misdiagnosis of heparin-induced thrombocytopenia (HIT) is common and exposes patients to high-risk therapies and potentially serious adverse events. The primary objective of this study was to evaluate the impact of collaboration between an inpatient pharmacy-driven anticoagulation management service (AMS) and hospital reference laboratory to reduce inappropriate HIT antibody testing via pharmacist intervention and use of the 4T pre-test probability score. Secondary objectives included clinical outcomes and cost-savings realized through reduced laboratory testing and decreased unnecessary treatment of HIT. This was a single center, pre-post, observational study. The hospital reference laboratory contacted the AMS when they received a blood sample for an enzyme-linked immunosorbent HIT antibody (HIT Ab). Trained pharmacists prospectively scored each HIT Ab ordered by using the 4T score with subsequent communication to physicians recommending for or against processing and reporting of lab results. Utilizing retrospective chart review and a database for all patients with a HIT Ab ordered during the study period, we compared the incidence of HIT Ab testing before and after implementation of the pharmacy-driven 4T score intervention. Our intervention significantly reduced the number of inappropriate HIT Ab tests processed (176 vs. 63, p < 0.0001), with no increase in thrombotic or hemorrhagic events. Overall incidence of suspected and confirmed HIT was <3 and <0.005 %, respectively. Overall cost savings were $75,754 (US) or 62 % per patient exposed to heparin between the pre and post intervention groups. Collaboration between inpatient pharmacy AMS and hospital reference laboratories can result in reduction of misdiagnosis of HIT and significant cost savings with similar safety.
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Anticoagulantes/efeitos adversos , Autoanticorpos/sangue , Heparina/efeitos adversos , Laboratórios Hospitalares , Erros Médicos , Trombocitopenia , Anticoagulantes/administração & dosagem , Heparina/administração & dosagem , Trombocitopenia/sangue , Trombocitopenia/induzido quimicamente , Trombocitopenia/diagnóstico , Trombocitopenia/economiaRESUMO
Venous thromboembolism (VTE) is a serious medical condition associated with significant morbidity and mortality, and an incidence that is expected to double in the next forty years. The advent of direct oral anticoagulants (DOACs) has catalyzed significant changes in the therapeutic landscape of VTE treatment. As such, it is imperative that clinicians become familiar with and appropriately implement new treatment paradigms. This manuscript, initiated by the Anticoagulation Forum, provides clinical guidance for VTE treatment with the DOACs. When possible, guidance statements are supported by existing published evidence and guidelines. In instances where evidence or guidelines are lacking, guidance statements represent the consensus opinion of all authors of this manuscript and are endorsed by the Board of Directors of the Anticoagulation Forum.The authors of this manuscript first developed a list of pivotal practical questions related to real-world clinical scenarios involving the use of DOACs for VTE treatment. We then performed a PubMed search for topics and key words including, but not limited to, apixaban, antidote, bridging, cancer, care transitions, dabigatran, direct oral anticoagulant, deep vein thrombosis, edoxaban, interactions, measurement, perioperative, pregnancy, pulmonary embolism, reversal, rivaroxaban, switching, \thrombophilia, venous thromboembolism, and warfarin to answer these questions. Non- English publications and publications > 10 years old were excluded. In an effort to provide practical information about the use of DOACs for VTE treatment, answers to each question are provided in the form of guidance statements, with the intent of high utility and applicability for frontline clinicians across a multitude of care settings.
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Anticoagulantes/uso terapêutico , Tromboembolia Venosa/tratamento farmacológico , Administração Oral , Anticoagulantes/efeitos adversos , Feminino , Humanos , Masculino , Guias de Prática Clínica como Assunto , Gravidez , Tromboembolia Venosa/sangueAssuntos
Betacoronavirus/isolamento & purificação , Técnicas de Laboratório Clínico/métodos , Infecções por Coronavirus/diagnóstico , Pneumonia Viral/diagnóstico , Índice de Gravidade de Doença , Tromboelastografia/métodos , COVID-19 , Teste para COVID-19 , Humanos , Masculino , Pessoa de Meia-Idade , Pandemias , SARS-CoV-2RESUMO
Integration of accepted practice standards into electronic health record systems can facilitate standardization of anticoagulation care delivery and result in improved anticoagulation safety. However, the majority of commonly used electronic health record systems are lacking the specialized features necessary for optimal anticoagulation management. The Task Force on Electronic Health Records of the New York State Anticoagulation Coalition provides such a Consensus Statement in this issue of the journal. The Anticoagulation Forum endorses these recommendations and advises the electronic health record industry and health information technology programmers at the institutional level to adopt these recommendations in a comprehensive and timely manner.
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Anticoagulantes/uso terapêutico , Registros Eletrônicos de Saúde , HumanosRESUMO
Background: Venous thromboembolism (VTE) is a major health problem and common cause of morbidity and mortality in hospitalized patients. While trials in both surgical and medically ill patients have demonstrated efficacy and safety of enoxaparin for VTE prophylaxis (VTEP), they failed to adequately represent morbidly obese (body mass index > 40 kg/m2) patients. Objective: To assess the impact of a weight-adjusted enoxaparin dosing algorithm on anti-factor Xa levels, thrombosis, and bleeding in morbidly obese patients. Methods: A retrospective chart review was conducted, which included morbidly obese patients receiving VTEP with adjusted-dose enoxaparin. Patients received enoxaparin 0.5 mg/kg subcutaneously once or twice daily based on VTE risk. An anti-factor Xa level was drawn 3 to 5 hours after 2 or more consecutive doses. The primary outcome was the percentage of patients achieving target anti-factor Xa levels, defined as 0.2 to 0.6 IU/mL. Secondary outcomes included the incidence of symptomatic VTE and major bleeding. Results: Of the 182 charts reviewed, 141 anti-factor Xa levels from 130 patients met inclusion criteria. The study population was 44% male, and the median body mass index was 45.6 kg/m2. A total of 120 anti-factor Xa levels (85.1%) were within the target prophylactic range. Sixteen anti-factor Xa levels (11.3%) were below target range, and 5 (3.4%) were above range. The only significant difference among the 3 groups was baseline renal function (P = .035). There were 2 thromboembolic events and 1 major bleed in the study population. Conclusion: A weight-based VTEP dosing strategy for morbidly obese patients is effective without an apparent increase in adverse events.
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The aim of this study is to evaluate and describe the utilization and safety of 4F-PCC in a nonanticoagulated, surgical patient population at an academic, tertiary care center. This retrospective, single-center chart review evaluated nonanticoagulated adult patients at least 18âyears of age who had at least one dose of 4F-PCC administered between 1 January 2017 and 30 September 2022 for a surgical or peri-procedural indication. Hemostatic efficacy following 4F-PCC administration was the primary outcome, assessed by subsequent blood product administration and hemoglobin and hematocrit reduction. Secondary outcomes included an assessment of thrombotic events within 30âdays post-4F-PCC administration, in-hospital mortality, and the length of hospital stay. A total of 71 patients met the inclusion criteria, with 61 patients receiving 4F-PCC for cardiac surgery and 10 patients for other intraoperative or peri-procedural indications. The mean total 4F-PCC dose was 25.0âU/kg. For the primary outcome of hemostatic efficacy, 81% of patients had excellent hemostasis; however, blood product administration was reported in 95.8% of patients post-4F-PCC. Thromboembolic events occurred in 10 (14.1%) patients and 21.1% of patients expired prior to discharge in the total cohort. Off-label 4F-PCC use in nonanticoagulated patients is reported despite a lack of robust guidance for use. Following 4F-PCC administration, hemostatic efficacy based on hemoglobin and hematocrit changes was observed; however, blood product use was frequent, and 4F-PCC administration was not without risks, including thromboembolic complications such deep vein thrombosis (DVT), pulmonary embolism, and stroke. Further studies are needed to validate the off-label administration of 4F-PCC in nonanticoagulated patients.