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1.
Am J Emerg Med ; 49: 326-330, 2021 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-34224954

RESUMO

INTRODUCTION: Four-factor prothrombin complex concentrate (4PCC) is the preferred reversal agent for warfarin reversal, although the ideal dose is unknown. Fixed-dose 4PCC offers simplified dosing compared to standard-dosing algorithms with potentially lower risks of thromboembolic complications given lower doses are typically utilized. METHODS: Retrospective, observational, multicentered, pre- post- study of patients who received 4PCC for warfarin reversal among four hospitals within the same regional health system. Standard-dose patients received variable doses ranging from 25 to 50 units/kg based on total body weight and initial INR and fixed-dose patients received 2000 units. The primary outcome was achievement of a target INR ≤ 1.4 on the first post-4PCC INR result. RESULTS: After exclusions, 48 and 42 patients were analyzed in the standard-dose and fixed-dose groups, respectively. There was no difference in the ability to achieve a target INR of ≤1.4 (82.6% vs 81.5%, p = 0.14). Both groups received the same median dose of 2000 units, although fixed-dose patients actually received a higher weight-based dose than standard-dose patients (27 units/kg vs 24.5 units/kg). CONCLUSION: A fixed-dose 4PCC regimen of 2000 units among patients with ICH was as effective as standard-dose 4PCC for INR reversal among patients with ICH. However, fixed-doses of 2000 units at times exceeded standard 4PCC doses which may be contradictory to the goals of fixed-dose 4PCC for warfarin reversal.


Assuntos
Fatores de Coagulação Sanguínea/administração & dosagem , Hemorragias Intracranianas/complicações , Varfarina/efeitos adversos , Varfarina/antagonistas & inibidores , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/efeitos adversos , Fatores de Coagulação Sanguínea/uso terapêutico , Feminino , Humanos , Hemorragias Intracranianas/tratamento farmacológico , Hemorragias Intracranianas/fisiopatologia , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Estatísticas não Paramétricas
2.
Am J Emerg Med ; 41: 265.e5-265.e8, 2021 03.
Artigo em Inglês | MEDLINE | ID: mdl-33010991

RESUMO

Intracranial hemorrhage (ICH) is a known complication in patients with ventricular assist devices (VAD). We present a case of a 42-year-old male with a VAD and on warfarin who presented to the emergency department with ICH necessitating anticoagulant reversal. An attenuated dose of 15 units/kg of 4-factor prothrombin complex-concentrates (4F-PCC) was given and the patient's coagulation profile was subsequently assessed using rotational thromboelastometry (ROTEM®) to determine appropriateness of reversal. ROTEM® analysis showed adequate reversal at the time of assessment and the patient ultimately returned home without further functional deficits, highlighting the role of ROTEM® to guide anticoagulation reversal in the VAD patient population.


Assuntos
Anticoagulantes , Fatores de Coagulação Sanguínea/uso terapêutico , Coração Auxiliar/efeitos adversos , Hemorragias Intracranianas/tratamento farmacológico , Hemorragias Intracranianas/etiologia , Tromboelastografia , Varfarina/antagonistas & inibidores , Adulto , Humanos , Masculino
3.
Neurol Med Chir (Tokyo) ; 61(1): 47-54, 2021 Jan 15.
Artigo em Inglês | MEDLINE | ID: mdl-33208582

RESUMO

Warfarin remains crucially involved in the treatment of patients at thrombotic or thromboembolic risk. However, warfarin increases the mortality rate among patients with traumatic intracranial hemorrhage (TICH) through progressive hemorrhagic injury (PHI). Therefore, a rapid anticoagulation reversal could be required in patients with TICH to prevent PHI. Differences in the warfarin reversal effect between combination therapy of prothrombin complex concentrate (PCC) with vitamin K (VK) and VK monotherapy remain unclear. However, studies have reported that PCC has greater effectiveness and safety for warfarin reversal compared with fresh frozen plasma (FFP). This retrospective study aimed to evaluate the warfarin reversal effects of combination therapy of PCC with VK and VK monotherapy on TICH. We compared the clinical outcomes between the periods before and after the PCC introduction in our hospital. There were 13 and 7 patients who received VK monotherapy and PCC with VK, respectively. PHI predictors were evaluated using univariate regression analyses. Warfarin reversal using PCC had a significant negative association with PHI (odds ratio: 0.03, 95% confidence interval: 0.00-0.41, P = 0.004). None of the patients presented with thrombotic complications. Warfarin reversal through a combination of PCC with VK could be more effective for inhibiting post-trauma PHI compared with VK monotherapy. This could be attributed to a rapid and stable warfarin reversal. PCC should be administered to patients with TICH taking warfarin for PHI prevention.


Assuntos
Anticoagulantes/efeitos adversos , Fatores de Coagulação Sanguínea/uso terapêutico , Coagulação Sanguínea/efeitos dos fármacos , Hemorragia Intracraniana Traumática/tratamento farmacológico , Vitamina K/uso terapêutico , Varfarina/efeitos adversos , Varfarina/antagonistas & inibidores , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/uso terapêutico , Quimioterapia Combinada , Feminino , Estudo Historicamente Controlado , Humanos , Japão , Masculino , Estudos Retrospectivos , Varfarina/uso terapêutico
4.
Am J Emerg Med ; 38(10): 2096-2100, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-33152586

RESUMO

INTRODUCTION: Previous studies have shown fixed-dose 4PCC to be as effective as standard-dose 4PCC for warfarin reversal. However, certain patient populations such as those with high total body weight (TBW) or elevated baseline INR may be at increased risk for treatment failure. The purpose of this study was to validate the efficacy of a novel fixed-dose 4PCC protocol for warfarin reversal. METHODS: This was a multi-centered observational comparison of patients who received 4PCC for warfarin reversal. Fixed-dose patients received 1500 units of 4PCC with the dose increased to 2000 units in patients with a baseline INR ≥ 7.5, a TBW ≥ 100 kg, or for intracranial hemorrhage (ICH). Standard-dosing followed manufacturer recommendations. The primary outcome was achievement of a post-4PCC INR of ≤1.4. Secondary outcomes included target INR achievement among patients with a baseline INR ≥ 7.5, a TBW ≥ 100 kg, or neurologic bleeding indications; hospital length of stay; cost of therapy; and thromboembolic complications. RESULTS: A total of 116 patients were included in the standard-dose group and 75 in the fixed-dose group. There was no difference in the primary outcome (65% vs 57%, p = 0.32). There was no difference in secondary outcomes aside from cost of therapy in which fixed-dose 4PCC was less expensive than standard-dose 4PCC. CONCLUSION: A fixed-dose 4PCC regimen for warfarin reversal of 1500 units, with an increased dose of 2000 units for select patients, is as effective as standard-dose 4PCC for INR reversal.


Assuntos
Fatores de Coagulação Sanguínea/uso terapêutico , Hemorragia/tratamento farmacológico , Varfarina/antagonistas & inibidores , Idoso , Idoso de 80 Anos ou mais , Fatores de Coagulação Sanguínea/farmacologia , Distribuição de Qui-Quadrado , Feminino , Hemorragia Gastrointestinal/tratamento farmacológico , Hemorragia Gastrointestinal/fisiopatologia , Hemorragia/fisiopatologia , Humanos , Hemorragias Intracranianas/tratamento farmacológico , Hemorragias Intracranianas/fisiopatologia , Masculino , Pessoa de Meia-Idade , Varfarina/efeitos adversos , Varfarina/uso terapêutico
5.
Blood Coagul Fibrinolysis ; 31(2): 127-131, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-31934885

RESUMO

: The efficacy of three-factor prothrombin complex concentrates (PCCs) in the reversal of vitamin K antagonists is still a matter of debate. We compared the 'in-vitro' effect of three PCCs (one three-factor and two four-factor) on international normalized ratio (INR), thrombin generation and thromboelastometry of patients at different degrees of anticoagulation with vitamin K antagonist. We tested three concentrations of PCC (0.5, 1 and 1.5 U/ml) in six patients: three (INR 2.0-2.9) and three (INR 3.0-4.0). In this preliminary phase, we determined the lowest effective dose for a target INR less than 1.5 and to normalize endogenous thrombin potential and clotting time in EXTEM assay. In the validation phase, we tested the effect of the newly determined lowest effective PCC dose on samples of 40 (INR 2.0-2.9) and 20 (INR 3.0-4.0) patients. The minimum efficacious dosage to achieve the target INR with three-factor PCC (3-PCC) was 0.5 (INR 2.0-2.9) and 1.5 U/ml (INR 3.0-4.0). Four-factor PCCs (4-PCCs) achieved target INR with the lowest dose (0.5 U/ml) independently of baseline INR. Thrombin generation endogenous thrombin potential and EXTEM clotting time achieved normal values with the lowest dose (0.5 U/ml) of either 3-PCC or 4-PCC independently of baseline INR. Data observed in the preliminary phase were confirmed in the validation phase. 3-PCC appears to be as effective as 4-PCC in reversing oral anticoagulant treatment based on thrombin generation and EXTEM data, but not INR data, at least in the range of INR considered in our study. Further studies are needed to address the clinical implications of our results.


Assuntos
Fatores de Coagulação Sanguínea/administração & dosagem , Monitoramento de Medicamentos/métodos , Tromboelastografia/métodos , Trombina/biossíntese , Varfarina/farmacologia , Idoso , Antídotos , Fatores de Coagulação Sanguínea/farmacologia , Testes de Coagulação Sanguínea , Relação Dose-Resposta a Droga , Feminino , Humanos , Coeficiente Internacional Normatizado , Masculino , Pessoa de Meia-Idade , Varfarina/antagonistas & inibidores , Varfarina/uso terapêutico
6.
Am J Emerg Med ; 38(4): 806-809, 2020 04.
Artigo em Inglês | MEDLINE | ID: mdl-31864879

RESUMO

BACKGROUND: Dosing of four factor prothrombin complex concentrate (4PCC) for warfarin reversal remains controversial. Recently, the American College of Cardiology (ACC) recommended a low-dose PCC regimen as an option for warfarin reversal in acute major bleeding. We performed a retrospective study evaluating if a modified version of the ACC guideline recommendations was effective for warfarin reversal in acute major bleeds when compared to traditional variable dosing. METHODS: This was a retrospective cohort study of patients who received 4PCC for warfarin reversal in a 12 month period. We included patients that were ≥18 years of age, received 4PCC for warfarin reversal, and had an initial International Normalized Ratio (INR) of >2. Our primary outcome was the number of patients who had a post-4PCC infusion INR of <1.6. RESULTS: A total of 60 patients were included in the final analysis with 30 patients stratified to the traditional dosing and low-dose groups, respectively. Patient demographics were similar between both groups. We found no difference in the number of patients who had a post-4PCC infusion INR <1.6 between the traditional dosing and low dosing group (90.0% vs. 86.7%; p = 0.68). Additionally, we found no difference between post-infusion median INRs in each group (1.35 vs. 1.30; p = 0.16). Approximately 1000 units per patient were spared when utilizing the low-dose regimen. CONCLUSION: A modified version of the ACC's low-dose 4PCC option for warfarin reversal achieves similar outcomes for lowering INR values compared to traditional variable dosing regimens.


Assuntos
Anticoagulantes/efeitos adversos , Fatores de Coagulação Sanguínea/administração & dosagem , Varfarina/antagonistas & inibidores , Idoso , Idoso de 80 Anos ou mais , Fatores de Coagulação Sanguínea/uso terapêutico , Feminino , Hemorragia/induzido quimicamente , Hemorragia/tratamento farmacológico , Humanos , Coeficiente Internacional Normatizado , Masculino , Pessoa de Meia-Idade , Guias de Prática Clínica como Assunto , Estudos Retrospectivos , Resultado do Tratamento , Varfarina/efeitos adversos
7.
ASAIO J ; 66(5): 482-488, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-31192853

RESUMO

Durable left ventricular assist device (LVAD) recipients require long-term anticoagulation to prevent thromboembolic complications. Their management is complicated by the risk of bleeding, which may require rapid anticoagulation reversal. We conducted a narrative review of data published from January 2007 to September 2018, analyzing anticoagulation reversal strategies in patients with durable, continuous-flow LVADs. The aim of this review is to provide guidance for reversal strategies in patients with LVADs experiencing bleeding complications or needing urgent surgical procedures, incorporating four-factor prothrombin complex concentrate (4F-PCC). Most data were from small, retrospective studies. Data for 4F-PCC use were more robust for heart transplant than for other surgical procedures or bleeding management. In patients undergoing heart transplant, 4F-PCC reversed warfarin more rapidly and reduced total blood product use versus other reversal strategies. Most surgical procedures were conducted without excess bleeding when utilizing 4F-PCCs. Time to warfarin reversal was shorter when managing intracranial hemorrhage with 4F-PCC. No differences in thromboembolic rates between 4F-PCC and control groups were observed. Overall, the use of 4F-PCC resulted in more rapid and predictable warfarin reversal in LVAD patients with no apparent risk of thromboembolism. Well-designed, larger prospective trials are required to better define 4F-PCC use in patients with LVADs.


Assuntos
Fatores de Coagulação Sanguínea/uso terapêutico , Coração Auxiliar/efeitos adversos , Varfarina/antagonistas & inibidores , Idoso , Anticoagulantes/uso terapêutico , Feminino , Humanos , Coeficiente Internacional Normatizado , Masculino , Tromboembolia/etiologia , Tromboembolia/prevenção & controle
8.
J Emerg Med ; 57(1): 82-84, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31060844

RESUMO

BACKGROUND: Vitamin K antagonist (VKA) reversal in patients with acute major bleeding and coagulopathy is an example of an urgent intervention in the emergency department. Intravenous (IV) prothrombin complex concentrate (PCC) may reverse VKA-induced coagulopathy in <30 min. In patients lacking IV access, effective PCC administration becomes problematic. No previous case reports have documented PCC infusion via intraosseous (IO) or alternative routes in this setting. CASE REPORT: A 74-year-old man presented to the emergency department (ED) after a head injury, with sudden onset of left-sided facial droop, weakness, hypertension, and dizziness. Initial vital signs include blood pressure of 221/102 mm Hg, a heart rate of 75 beats/min, and oxygen saturation of 96% on room air. Warfarin 3 mg once daily was among his medications. His international normalized ratio (INR) was 3.9 with a computed tomography scan showing intraparenchymal hemorrhage in the right temporal lobe. Multiple attempts for IV access at various sites were unsuccessful. Therefore, IO access was established. Because of his prolonged prothrombin time, elevated INR, and intraparenchymal hemorrhage, the decision was made to use 4-factor PCC to reverse the supratherapeutic INR. The INR normalized as an emergent right parietal hematoma evacuation was performed. After an inpatient course, the patient was eventually discharged. WHY SHOULD AN EMERGENCY PHYSICIAN BE AWARE OF THIS?: VKAs, like warfarin, are commonly prescribed medications. When life-threatening hemorrhage is present, rapid reversal of a VKA-induced coagulopathy may be a life-saving therapy. In the event that IV access has not been established, we have demonstrated that IO access is a viable alternative route for PCC administration.


Assuntos
Fatores de Coagulação Sanguínea/administração & dosagem , Fatores de Tempo , Varfarina/antagonistas & inibidores , Idoso , Anticoagulantes/efeitos adversos , Fatores de Coagulação Sanguínea/uso terapêutico , Tontura/etiologia , Hemorragia/tratamento farmacológico , Hemorragia/prevenção & controle , Humanos , Hipertensão/etiologia , Infusões Intraósseas/métodos , Masculino , Debilidade Muscular/etiologia , Varfarina/efeitos adversos
9.
ASAIO J ; 65(2): e21-e24, 2019 02.
Artigo em Inglês | MEDLINE | ID: mdl-29561270

RESUMO

Left ventricular assist devices (LVADs) have become an important advancement for patients with end-stage heart failure. Left ventricular assist devices come with the risk of stroke and pump thrombosis, and to mitigate these risks, anticoagulation is given to these patients. With anticoagulation comes increased bleeding risk, and urgent reversal may be necessary. Reports have shown that the risk of thrombosis with prothrombin complex concentrate (PCC) does exist, especially in patients with baseline risk factors for thrombosis. We describe two cases of warfarin reversal with low-dose 4-factor PCC (4F-PCC) in two different LVAD patient scenarios. Low-dose 4F-PCC was administered to one patient with a Heart Mate II (HM II) LVAD, international normalized ratio (INR) of 4.7 on admission and in need of an urgent procedure. He received approximately 16 units/kg of 4F-PCC with reversal of his INR to 2.3 within 45 minutes. The second patient also had a HM II LVAD and presented with a right occipital intraparenchymal hemorrhage and subdural hematoma with an INR of 3.7. He received approximately 11 units/kg of 4F-PCC with INR reversal to 1.6 within 1 hour. Both of these patients had no thrombotic complications and successful reversal of their INR with low-dose 4F-PCC. Further investigation into low-dose 4F-PCC dosing strategies is warranted.


Assuntos
Anticoagulantes/efeitos adversos , Fatores de Coagulação Sanguínea/uso terapêutico , Coração Auxiliar/efeitos adversos , Hemorragia/induzido quimicamente , Varfarina/antagonistas & inibidores , Idoso , Humanos , Coeficiente Internacional Normatizado , Masculino , Complicações Pós-Operatórias/prevenção & controle , Estudos Retrospectivos , Trombose/prevenção & controle
10.
Can J Surg ; 62(1): 14-19, 2019 02 01.
Artigo em Inglês | MEDLINE | ID: mdl-30265643

RESUMO

BACKGROUND: Patients with hip fracture who present anticoagulated with warfarin often require reversal of anticoagulation for safe hip fracture surgery. Vitamin K is typically administered for this, but requires 24-48 hours for maximal effect. These patients have an increased delay to surgery and increased mortality. Octaplex is a prothrombin complex concentrate (PCC) that reverses warfarin anticoagulation in less than an hour. This study assesses the effectiveness and safety of Octaplex for reversal of warfarin anticoagulation for hip fracture surgery. METHODS: We reviewed the medical records of all patients with hip fracture in Calgary who received Octaplex between 2009 and 2015. Timing of admission, Octaplex administration and hip fracture surgery were recorded. Mortality and cardiac, thrombotic and orthopedic complications were assessed. RESULTS: Median time from Octaplex administration to an international normalized ratio of 1.4 or lower was 1.1 hours. The median time from admission to surgery was 22 hours. Thirty-day mortality was 15.2%, with 4 cases of cardiac arrest and 1 respiratory arrest. Patients who received both Octaplex and fresh frozen plasma (FFP) had a lower rate of 30-day survival than those who received only Octaplex (95.7% v. 60.0%, p = 0.002). CONCLUSION: There were significant rates of cardiac events and 30-day mortality among patients who received Octaplex, but this is unsurprising in this population with multiple medical comorbidities. We caution against administrering both FFP and a PCC in patients for warfarin reversal. Octaplex is effective for rapidly reversing warfarin anticoagulation and reducing delays to hip fracture surgery. Further study comparing Octaplex to reversal using only vitamin K is required.


Assuntos
Anticoagulantes , Transtornos da Coagulação Sanguínea/tratamento farmacológico , Fatores de Coagulação Sanguínea/administração & dosagem , Fraturas do Quadril/cirurgia , Varfarina/antagonistas & inibidores , Idoso , Idoso de 80 Anos ou mais , Coagulação Sanguínea/efeitos dos fármacos , Transtornos da Coagulação Sanguínea/induzido quimicamente , Fatores de Coagulação Sanguínea/efeitos adversos , Feminino , Humanos , Coeficiente Internacional Normatizado , Masculino , Estudos Retrospectivos , Fatores de Tempo , Tempo para o Tratamento , Resultado do Tratamento
11.
J Thromb Thrombolysis ; 47(2): 263-271, 2019 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-30443817

RESUMO

BACKGROUND: Four-factor PCC is the recommended standard of care for acute warfarin reversal but optimal dosing is unknown. We aim to show that a low-dose strategy is often adequate and may reduce the risk of thromboembolic events when compared to manufacturer-recommended dosing. METHODS: A weight-based dosing strategy of 15-25 units/kg was established as the institutional standard of care in May 2015. This retrospective, before-and-after cohort analysis included patients receiving 4F-PCC according to a manufacturer-recommended (n = 122) or a low-dose (n = 83) strategy. The primary efficacy outcome was a combination of INR reversal on first check and hemostatic efficacy at 24 h. RESULTS: Demographics, indications for warfarin, and presenting INR values were similar between the two groups. Patients in the manufacturer-recommended dose group received significantly more 4F-PCC than the low dose group (2110 units vs. 1530 units). More patients in the manufacturer-recommended dose group achieved the primary endpoint (75.4% vs. 61.4%), with more patients achieving the target INR on recheck in the manufacturer-recommended dose group (95.9% vs. 84.3%) and no difference in hemostatic efficacy between groups (79.5% vs. 74.7%). There was no difference in thromboembolic events at 72 h (4.1% vs. 1.2%) or at 30 days (8.2% vs. 4.8%). Significantly more patients in the manufacturer-recommended dose group died or were transferred to hospice care during hospitalization (21.3% vs. 9.6%). CONCLUSION: Utilization of a low-dose 4F-PCC strategy resulted in fewer patients achieving target INR reversal, but no difference in hemostatic efficacy, thromboembolic events, or survival.


Assuntos
Anticoagulantes , Fatores de Coagulação Sanguínea/administração & dosagem , Hemorragia/tratamento farmacológico , Hemostasia/efeitos dos fármacos , Antagonistas de Heparina/administração & dosagem , Varfarina/antagonistas & inibidores , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/administração & dosagem , Anticoagulantes/efeitos adversos , Fatores de Coagulação Sanguínea/efeitos adversos , Peso Corporal , Cálculos da Dosagem de Medicamento , Monitoramento de Medicamentos/métodos , Feminino , Hemorragia/induzido quimicamente , Hemorragia/diagnóstico , Antagonistas de Heparina/efeitos adversos , Humanos , Coeficiente Internacional Normatizado , Masculino , Modelos Biológicos , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Resultado do Tratamento , Varfarina/administração & dosagem , Varfarina/efeitos adversos
12.
J Thromb Thrombolysis ; 46(2): 180-185, 2018 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-29785470

RESUMO

Continuous flow left ventricular assist devices (CF-LVAD) require therapeutic anticoagulation which is often interrupted for procedures or bleeding. Prior to the availability of four factor prothrombin complex concentrate (4F-PCC) in the United States, warfarin was held and its effects reversed by vitamin K or fresh frozen plasma. We evaluated the use of 4F-PCC for temporary warfarin reversal in patients with CF-LVADs and assessed outcomes. This analysis is a retrospective study of CF-LVAD patients who received 4F-PCC for warfarin reversal in the setting of bleeding or need for urgent or elective procedures. Primary outcome assessments included feasibility of administration in elective versus emergent situations, safety measured as incidence of thrombotic events, and change in INR after administration. In total, 37 CF-LVAD patients received 49 4F-PCC administrations. The average 4F-PCC dose was 1842 units (range 518-4292 units), or 22 units/kg (range 5.8-58 units/kg). 4F-PCC significantly decreased the mean INR from 2.9 to 1.7 (p < 0.0001) in 47 of 49 administrations; two patients did not have post infusion INR testing. No cases of new confirmed or suspected pump thrombosis, stroke, venous thromboembolism, arterial thrombosis, or myocardial infarction were observed within 30 days of administration of 4F-PCC. 4F-PCC administration for temporary warfarin reversal was demonstrated to be feasible, effective, and, safe in CF-LVAD patients and judged to be 96% effective in patients for whom data were available. We observed no thrombotic events attributed to use of 4F-PCC.


Assuntos
Fatores de Coagulação Sanguínea/uso terapêutico , Coração Auxiliar , Varfarina/antagonistas & inibidores , Idoso , Idoso de 80 Anos ou mais , Fatores de Coagulação Sanguínea/farmacologia , Interações Medicamentosas , Ventrículos do Coração/cirurgia , Humanos , Coeficiente Internacional Normatizado , Pessoa de Meia-Idade , Resultado do Tratamento , Varfarina/uso terapêutico
13.
J Surg Res ; 223: 183-187, 2018 03.
Artigo em Inglês | MEDLINE | ID: mdl-29433872

RESUMO

BACKGROUND: Patients with traumatic intracranial hemorrhage (TIH) anticoagulated with warfarin are at an increased risk of mortality. Fresh frozen plasma (FFP) and vitamin K have been the standard treatment for warfarin reversal; however, guidelines now recommend the use of prothrombin complex concentrate (PCC) for warfarin reversal in patients with life-threatening bleeding. Our protocol uses one vial (∼1000 units) of activated PCC (aPCC) for warfarin reversal, regardless of the weight or presenting international normalized ratio (INR). The purpose of this study was to determine the safety and efficacy of using fixed, low-dose aPCC for warfarin reversal in patients with TIH. METHODS: This was a retrospective chart review that included patients with an Abbreviated Injury Scale Head score of ≥3, TIH, and initial INR ≥ 1.5 on warfarin. Patients aged <18 years and those with no repeat INR were excluded. The primary outcome was to compare the percentage of patients with INR ≤ 1.4 after receiving aPCC versus FFP within 24 hours. RESULTS: Eighty-nine patients were in the FFP group and 31 patients in the aPCC group. The INR was reversed more effectively in the aPCC group compared with the FFP group (90.3% versus 69.7%, P = 0.029). The median time (hours) to reversal was also significantly shorter in the aPCC group compared with the FFP group (3.75 versus 6.75, P = 0.003). However, there was no difference in mortality (35.5% aPCC versus 22.2% control, P = 0.162) or incidences of thrombosis. CONCLUSION: Fixed, low-dose aPCC is safe and more effective at reversing the effects of warfarin than FFP in patients with TIH.


Assuntos
Fatores de Coagulação Sanguínea/uso terapêutico , Hemorragia Intracraniana Traumática/tratamento farmacológico , Varfarina/antagonistas & inibidores , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Coeficiente Internacional Normatizado , Masculino , Estudos Retrospectivos
14.
Neurosurgery ; 82(6): 877-886, 2018 06 01.
Artigo em Inglês | MEDLINE | ID: mdl-29106685

RESUMO

BACKGROUND: Reversal of therapeutic anticoagulation prior to emergency neurosurgical procedures is required in the setting of intracranial hemorrhage. Multifactor prothrombin complex concentrate (PCC) promises rapid efficacy but may increase the probability of thrombotic complications compared to fresh frozen plasma (FFP). OBJECTIVE: To compare the rate of thrombotic complications in patients treated with PCC or FFP to reverse therapeutic anticoagulation prior to emergency neurosurgical procedures in the setting of intracranial hemorrhage at a level I trauma center. METHODS: Sixty-three consecutive patients on warfarin therapy presenting with intracranial hemorrhage who received anticoagulation reversal prior to emergency neurosurgical procedures were retrospectively identified between 2007 and 2016. They were divided into 2 cohorts based on reversal agent, either PCC (n = 28) or FFP (n = 35). The thrombotic complications rates within 72 h of reversal were compared using the χ2 test. A multivariate propensity score matching analysis was used to limit the threat to interval validity from selection bias arising from differences in demographics, laboratory values, history, and clinical status. RESULTS: Thrombotic complications were uncommon in this neurosurgical population, occurring in 1.59% (1/63) of treated patients. There was no significant difference in the thrombotic complication rate between groups, 3.57% (1/28; PCC group) vs 0% (0/35; FFP group). Propensity score matching analysis validated this finding after controlling for any selection bias. CONCLUSION: In this limited sample, thrombotic complication rates were similar between use of PCC and FFP for anticoagulation reversal in the management of intracranial hemorrhage prior to emergency neurosurgical procedures.


Assuntos
Fatores de Coagulação Sanguínea/uso terapêutico , Hemorragias Intracranianas/cirurgia , Plasma , Tromboembolia/epidemiologia , Varfarina/antagonistas & inibidores , Idoso , Anticoagulantes/uso terapêutico , Feminino , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Procedimentos Neurocirúrgicos/métodos , Pontuação de Propensão , Estudos Retrospectivos , Centros de Traumatologia
15.
Nurse Pract ; 42(11): 8-14, 2017 Nov 16.
Artigo em Inglês | MEDLINE | ID: mdl-28957948

RESUMO

For more than half a century, warfarin, a vitamin K antagonist, has been the anticoagulant of choice. However, direct oral anticoagulants are rapidly gaining in popularity, which poses the need for efficacious reversal agents. This review article summarizes the strategies and agents used to reverse oral anticoagulants.


Assuntos
Anticoagulantes/administração & dosagem , Dabigatrana/antagonistas & inibidores , Pirazóis/antagonistas & inibidores , Piridinas/antagonistas & inibidores , Piridonas/antagonistas & inibidores , Rivaroxabana/antagonistas & inibidores , Tiazóis/antagonistas & inibidores , Varfarina/antagonistas & inibidores , Administração Oral , Ensaios Clínicos Fase III como Assunto , Humanos
17.
Vox Sang ; 112(6): 595-597, 2017 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-28635130

RESUMO

For emergent warfarin reversal, four-factor prothrombin complex concentrates (4FPCCs) are recommended by many international guidelines. We surveyed international clinical sites including members of the Biomedical Excellence for Safer Transfusion (BEST) Collaborative. Most sites have emergent warfarin reversal protocols (53% use PCC, 25% use PCC+ plasma and 2% use plasma alone); however, variation between adjusted dosing and fixed dosing was observed.


Assuntos
Anticoagulantes , Fatores de Coagulação Sanguínea/uso terapêutico , Protocolos Clínicos , Hospitais , Varfarina/antagonistas & inibidores , Humanos , Plasma , Inquéritos e Questionários
18.
Med Klin Intensivmed Notfmed ; 112(2): 99-104, 2017 Mar.
Artigo em Alemão | MEDLINE | ID: mdl-28144725

RESUMO

The non-vitamin K antagonists (NOAC) are an integral component of our antithrombotic prevention and therapy. For four of the NOAC, their non-inferiority or even superiority versus vitamin K antagonists (VKA) has been proven. Thus, the management of special patient cohorts or the management of active bleeding complications is a focus of current discussion.In addition to prospective trials, numerous retrospective analyses of health insurers or public health provider data have been analyzed and published as "real life" or "real-world evidence" data. In almost all data sets the results of the NOAC approval trials were confirmed, demonstrating their non-inferiority or even superiority versus VKA. Attempts to compare the various NOAC with each other must be viewed critically since the real-world evidence (RWE) analysis provides very divergent results depending on the cohorts analyzed. Thus, a substantial prescriber-bias must be taken into account and never be excluded.In order to improve the management of bleeding complications, NOAC antidotes were developed. While the factors Xa antidote, andexanet alpha, a modified coagulation factor deleted of an intrinsic activity, will not be available before 2018, the dabigatran antidote idarucizumab is already in clinical use. Idarucizumab, a monoclonal antibody fragment directed against dabigatran, is able to completely antagonize the effect of dabigatran within minutes. Therefore, the drug has the potential to terminate life-threatening bleeding complications earlier and make emergency surgical or interventional procedures possible without an elevated bleeding risk.


Assuntos
Anticorpos Monoclonais Humanizados/efeitos adversos , Anticoagulantes/efeitos adversos , Anticoagulantes/uso terapêutico , Antídotos/uso terapêutico , Hemorragia/induzido quimicamente , Hemorragia/tratamento farmacológico , Acidente Vascular Cerebral/sangue , Acidente Vascular Cerebral/tratamento farmacológico , Tromboembolia/prevenção & controle , Idoso , Anticorpos Monoclonais Humanizados/uso terapêutico , Antídotos/efeitos adversos , Dabigatrana/efeitos adversos , Dabigatrana/antagonistas & inibidores , Dabigatrana/uso terapêutico , Fator Xa/efeitos adversos , Fator Xa/uso terapêutico , Inibidores do Fator Xa/efeitos adversos , Inibidores do Fator Xa/uso terapêutico , Feminino , Humanos , Masculino , Pirazóis/efeitos adversos , Pirazóis/antagonistas & inibidores , Piridonas/efeitos adversos , Piridonas/antagonistas & inibidores , Proteínas Recombinantes/efeitos adversos , Proteínas Recombinantes/uso terapêutico , Rivaroxabana/efeitos adversos , Rivaroxabana/antagonistas & inibidores , Tromboembolia/sangue , Vitamina K/antagonistas & inibidores , Varfarina/efeitos adversos , Varfarina/antagonistas & inibidores
19.
J Emerg Med ; 52(1): 1-7.e1, 2017 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-27793500

RESUMO

BACKGROUND: Most comparisons of bleeding patients who are taking warfarin or a non-vitamin K oral anticoagulant (NOAC) have been limited to admitted patients and major bleeding events in well-controlled, clinical trial settings. OBJECTIVES: We describe the clinical characteristics, interventions, and outcomes in patients who are taking warfarin or a NOAC who presented to the emergency department (ED) with any bleeding event. METHODS: We conducted a structured, retrospective, observational study of nonvalvular atrial fibrillation, pulmonary embolism, or deep vein thrombosis warfarin- or NOAC-treated patients presenting with any bleeding event to a large, academic ED between January 2012 and March 2015. We used descriptive statistics to summarize baseline characteristics, treatments, and outcomes and performed subgroup analyses based on the type of anticoagulant and site of bleeding. RESULTS: The electronic search yielded 95 cases of patients taking a NOAC (i.e., dabigatran [33], rivaroxaban [32], or abixaban [30]) and 342 patients taking warfarin. Reversal agents were rarely used in all anticoagulant groups. Case fatality rates were similar among warfarin- and NOAC-treated patients for gastrointestinal bleeding (7% vs. 7%) and intracranial hemorrhage (18% vs. 4%), respectively. After adjustment for other factors, only intracranial hemorrhage (odds ratio 4.4; 95% confidence interval 1.4-13.3) was associated with mortality. CONCLUSIONS: Despite the rare use of reversal strategies, mortality was low and outcomes were comparable among patients with bleeding events presenting to the ED while taking a NOAC compared with warfarin.


Assuntos
Hemorragia/terapia , Avaliação de Resultados da Assistência ao Paciente , Varfarina/efeitos adversos , Administração Oral , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/farmacologia , Anticoagulantes/uso terapêutico , Serviço Hospitalar de Emergência/organização & administração , Serviço Hospitalar de Emergência/estatística & dados numéricos , Feminino , Hemorragia/mortalidade , Humanos , Masculino , Estudos Retrospectivos , Vitamina K/farmacologia , Vitamina K/uso terapêutico , Varfarina/antagonistas & inibidores
20.
Thromb Haemost ; 116(5): 879-890, 2016 Oct 28.
Artigo em Inglês | MEDLINE | ID: mdl-27488143

RESUMO

Urgent reversal of warfarin is required for patients who experience major bleeding or require urgent surgery. Treatment options include the combination of vitamin K and coagulation factor replacement with either prothrombin complex concentrate (PCC) or fresh frozen plasma (FFP). However, the optimal reversal strategy is unclear based on clinically relevant outcomes. We searched in MEDLINE, EMBASE and Cochrane library to December 2015. Thirteen studies (5 randomised studies and 8 observational studies) were included. PCC use was associated with a significant reduction in all-cause mortality compared to FFP (OR= 0.56, 95 % CI; 0.37-0.84, p=0.006). A higher proportion of patients receiving PCC achieved haemostasis compared to those receiving FFP, but this was not statistically significant (OR 2.00, 95 % CI; 0.85-4.68). PCC use was more likely to achieve normalisation of international normalised ratio (INR) (OR 10.80, 95 % CI; 6.12-19.07) and resulted in a shorter time to INR correction (mean difference -6.50 hours, 95 %CI; -9.75 to -3.24). Red blood cell transfusion was not statistically different between the two groups (OR 0.88, 95 % CI: 0.53-1.43). Patients receiving PCC had a lower risk of post-transfusion volume overload compared to FFP (OR 0.27, 95 % CI; 0.13-0.58). There was no statistically significant difference in the risk of thromboembolism following administration of PCC or FFP (OR 0.91, 95 % CI; 0.44-1.89). In conclusion, as compared to FFP, the use of PCC for warfarin reversal was associated with a significant reduction in all-cause mortality, more rapid INR reduction, and less volume overload without an increased risk of thromboembolic events.


Assuntos
Fatores de Coagulação Sanguínea/uso terapêutico , Plasma , Varfarina/antagonistas & inibidores , Anticoagulantes , Hemorragia/tratamento farmacológico , Humanos , Coeficiente Internacional Normatizado , Estudos Observacionais como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto
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