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1.
N Z Med J ; 134(1529): 69-79, 2021 02 05.
Artigo em Inglês | MEDLINE | ID: mdl-33582709

RESUMO

AIMS: This study aims to determine whether door-to-needle times (DNT) for reversal of anticoagulant-associated intracerebral haemorrhage (ICH) (1) have improved over time, (2) differ between warfarin and dabigatran and (3) are comparable to ischaemic stroke (IS) thrombolysis DNT, and (4) whether reversal is monitored. METHODS: Retrospective review of all warfarin- and dabigatran-associated ICH presenting to Christchurch Hospital over a 15-year period. DNT data from 2013-2018 were compared between warfarin-related ICH (WRICH), dabigatran-related ICH (DRICH) and IS thrombolysis. RESULTS: 172 WRICH were identified. Over time there were significant reductions in door-to-first-reversal-agent (r=-0.21, p=0.01), scan-to-first-reversal-agent (r=-0.27, p=0.001) and scan-to-prothrombin-complex-concentrate (PCC) (r=-0.33, p=0.001) times. In the 2013-2018 cohort, WRICH had significantly slower DNT, door-to-scan time and scan-to-needle time compared to DRICH and IS thrombolysis (all p<0.001). There was no statistical difference between DRICH and IS. Median DNT was 183 minutes for WRICH, 72 minutes for DRICH and 52 minutes for IS. Median time to repeat international normalised ratio was 231 minutes, and the median time to repeat thrombin clotting time was 825 minutes. CONCLUSION: Door-to-any-reversal-agent and scan-to-PCC times have improved over time, but they remain significantly longer than IS thrombolysis times. Monitoring of reversal is inadequate, particularly for WRICH receiving PCC.


Assuntos
Fatores de Coagulação Sanguínea/uso terapêutico , Hemorragias Intracranianas/induzido quimicamente , Hemorragias Intracranianas/tratamento farmacológico , Terapia Trombolítica/métodos , Terapia Trombolítica/normas , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/efeitos adversos , Fatores de Coagulação Sanguínea/administração & dosagem , Dabigatrana/efeitos adversos , Feminino , Humanos , Coeficiente Internacional Normatizado , Hemorragias Intracranianas/diagnóstico , Masculino , Pessoa de Meia-Idade , Nova Zelândia , Estudos Retrospectivos , Fatores de Tempo , Resultado do Tratamento , Varfarina/efeitos adversos
2.
Hematology ; 25(1): 489-493, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-33317427

RESUMO

BACKGROUND: Four-factor prothrombin complex concentrate (4F-PCC) is widely used for urgent reversal of anticoagulation with warfarin, but the optimal 4F-PCC dosing approach is unknown. Herein, we sought to determine the efficacy of a novel fixed, weight-based dosing nomogram. METHODS: We retrospectively studied consecutive adult patients receiving fixed, weight-based 4F-PCC dosing for warfarin reversal between 30 April 2009 and 31 December 2010. The primary outcome was reversal of warfarin anticoagulation, defined as INR ≤1.5 within 6 h. Secondary outcome was the occurrence of thromboembolic events. RESULTS: A total of 227 patients (56% male), with a median age of 74 years and a median weight of 76kg were evaluated. The most common indications for 4F-PCC were active bleeding (37.4%: 12.7% intracranial, 12.3% gastrointestinal, 4.0% trauma, 8.4% other), reversal for a procedure (22.0%), reversal for surgery (29.5%) or other (11.1%). 66.1% of patients achieved an INR ≤1.5 within 6 h of 4F-PCC administration. 95.0% (57/60) of patients completed a planned procedure and 95.7% (67/70) of patients completed a planned surgery. The median baseline INR was 2.9 (1.5-10) and decreased significantly to a median of 1.3 (1.0-3.7) (p < .001) post-4F-PCC administration. There was no statistically significant difference in response to a fixed, weight-based dose of 4F-PCC based on pre-PCC INR, as long as the pre-treatment INR was ≤ 4.5. Although the majority of patients in our study (99%) received doses over 1000IU, rates of thrombosis were low (1.8%). CONCLUSION: Fixed, weight-based dosing of 4F-PCC is effective for reversing warfarin anticoagulation in patients with a pre-dosing INR ≤ 4.5.


Assuntos
Anticoagulantes/efeitos adversos , Fatores de Coagulação Sanguínea/administração & dosagem , Fatores de Coagulação Sanguínea/efeitos adversos , Coagulação Sanguínea/efeitos dos fármacos , Varfarina/efeitos adversos , Adulto , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/administração & dosagem , Feminino , Hemorragia/tratamento farmacológico , Hemorragia/etiologia , Humanos , Coeficiente Internacional Normatizado , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Resultado do Tratamento , Varfarina/administração & dosagem
3.
Emerg Med Clin North Am ; 38(4): 871-889, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-32981623

RESUMO

Massive gastrointestinal hemorrhage is a life-threatening condition that can result from numerous causes and requires skilled resuscitation to decrease patient morbidity and mortality. Successful resuscitation begins with placement of large-bore intravenous or intraosseous access; early blood product administration; and early consultation with a gastroenterologist, interventional radiologist, and/or surgeon. Activate a massive transfusion protocol when initial red blood cell transfusion does not restore effective perfusion or the patient's shock index is greater than 1.0. Promptly reverse coagulopathies secondary to oral anticoagulant or antiplatelet use. Use thromboelastography or rotational thromboelastometry to guide further transfusions. Secure a definitive airway and minimize aspiration.


Assuntos
Hemorragia Gastrointestinal/terapia , Manuseio das Vias Aéreas , Antibacterianos/uso terapêutico , Anticorpos Monoclonais Humanizados/administração & dosagem , Anticoagulantes/efeitos adversos , Antifibrinolíticos/uso terapêutico , Oclusão com Balão , Fatores de Coagulação Sanguínea/administração & dosagem , Transfusão de Sangue/métodos , Cateteres , Serviço Hospitalar de Emergência , Fator Xa/administração & dosagem , Hemorragia Gastrointestinal/diagnóstico , Hemorragia Gastrointestinal/etiologia , Humanos , Infusões Intraósseas , Infusões Intravenosas , Anamnese , Exame Físico , Inibidores da Bomba de Prótons/uso terapêutico , Proteínas Recombinantes/administração & dosagem , Ressuscitação , Tromboelastografia , Vasoconstritores/uso terapêutico
5.
Hosp Pract (1995) ; 48(3): 123-127, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32295428

RESUMO

OBJECTIVES: Despite the availability of FDA-labeled anticoagulant reversal agents, there is considerable variability in clinical practice as to the regimen and agent used for reversal. The objective of this study was to characterize the current practices of pharmacists surrounding the reversal of anticoagulant-associated life-threatening hemorrhage. Methods: A cross-sectional analysis of critical care and emergency medicine pharmacists. Current practice was compared for the type of hospital, country region, and type of ordering physician. In addition, pharmacists were asked to rank their involvement with activities involved with the reversal of anticoagulants. Respondents ranked their involvement with these activities as either never involved, rarely involved, occasionally involved, frequently involved, or always involved. Results:281 respondents were included. The majority used 4-factor PCC for warfarin reversal (92.9%) and factor Xa inhibitor reversal (79.7%). However, only 58.7% used the labeled dose of 4-PCC for warfarin reversal. Of the 30.6% that utilized a fixed-dose regimen, the most common regimen was 1500 units once. A higher proportion of respondents practicing in a teaching hospital reported that they used activated prothrombin complex concentrates for reversal of factor Xa inhibitor (22 [12.2%] vs. 5 [5%]; p < 0.05) or coagulation factor Xa (recombinant)-inactivated-zhzo (31 [17.2%] vs. 5 [5%]; p < 0.05). In addition, the majority of respondents utilized idarucizumab for dabigatran reversal. The only involvement activity in which <50% of respondents said they were frequently involved or always involved was 'administration of reversal agent.' Conclusions: There is considerable variability in which agents were utilized for anticoagulant-associated bleeding reversal.


Assuntos
Anticoagulantes/efeitos adversos , Cuidados Críticos/organização & administração , Hemorragia/induzido quimicamente , Hemorragia/prevenção & controle , Hemostáticos/administração & dosagem , Anticorpos Monoclonais Humanizados/administração & dosagem , Fatores de Coagulação Sanguínea/administração & dosagem , Cuidados Críticos/normas , Estudos Transversais , Relação Dose-Resposta a Droga , Inibidores do Fator Xa/efeitos adversos , Humanos , Metilmetacrilatos , Padrões de Prática Médica , Características de Residência
6.
J Card Surg ; 35(4): 801-809, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-32048355

RESUMO

BACKGROUND: Patients who refuse allogeneic blood transfusions (alloBT) on the basis of religious doctrine, such as Jehovah's Witnesses (JWs), can pose a challenge when undergoing surgical procedures. During cardiac surgery, special considerations regarding surgical techniques and blood loss minimization strategies can lead to improved outcomes. Limited literature exists to guide the use of four-factor prothrombin complex concentrate (4PCC) in this patient population undergoing cardiac surgery. STUDY DESIGN AND METHODS: This retrospective, single-center study evaluated the impact of 4PCC on hemoglobin (Hgb) change from baseline to postoperative nadir within a 7-day period among patients who refused alloBT during cardiac surgery. This study identified patients who refused alloBT from January 2011 to June 2017. Multivariable linear regression was used to control for confounding variables to evaluate the effectiveness of 4PCC. RESULTS: During the study timeframe, 79 patients met inclusion criteria, all of whom identified as JWs, and underwent cardiac surgery. Of these, 19 received intraoperative 4PCC. Multivariable linear regression found no difference in Hgb change in patients who received 4PCC vs those who did not. No significant differences were found in mortality, thromboembolic complications, or in-hospital postoperative events. CONCLUSIONS: In JWs undergoing cardiac surgery who refuse alloBT, intraoperative use of 4PCC was not associated with a difference in Hgb change within 7 days postoperatively when adjusting for confounding variables. In the event of excessive blood loss, the utilization of 4PCC may provide a viable option in JW patients who undergo cardiac surgery where few options exist to mitigate blood loss.


Assuntos
Fatores de Coagulação Sanguínea/administração & dosagem , Procedimentos Cirúrgicos Cardíacos/métodos , Religião , Recusa do Paciente ao Tratamento , Idoso , Perda Sanguínea Cirúrgica/prevenção & controle , Transfusão de Sangue/psicologia , Feminino , Hemoglobinas/metabolismo , Humanos , Cuidados Intraoperatórios , Masculino , Pessoa de Meia-Idade , Avaliação de Resultados em Cuidados de Saúde , Período Pós-Operatório , Estudos Retrospectivos , Resultado do Tratamento
7.
Br J Hosp Med (Lond) ; 81(2): 1-6, 2020 Feb 02.
Artigo em Inglês | MEDLINE | ID: mdl-32097070

RESUMO

BACKGROUND/AIMS: Four-factor prothrombin complex concentrate is the first-line treatment in vitamin K antagonist-related intracerebral haemorrhage. Early administration is associated with improved patient outcomes. A quality improvement project investigated delays in prothrombin complex concentrate administration in vitamin K antagonist-related intracerebral haemorrhage in order to reduce the time from computed tomography scan confirming intracerebral haemorrhage to prothrombin complex concentrate administration (scan-to-needle time). METHOD: Twenty patients were identified by retrospective audit over a 3-year period. The median scan-to-needle time for prothrombin complex concentrate was 156 minutes. Several points of delay were identified, including contacting both haematology and transfusion departments for prothrombin complex concentrate dosing and dispensing. Following this audit, interventions were brought in which included the introduction of a protocol with a prothrombin complex concentrate dosing algorithm, negating the need to contact haematology before administration. A dedicated supply of prothrombin complex concentrate was given to the stroke unit avoiding the need to contact the transfusion service. RESULTS: A re-audit showed a 68% reduction in median scan-to-needle time from 156 minutes to 49 minutes. Prospective data collection is ongoing.


Assuntos
Fatores de Coagulação Sanguínea/uso terapêutico , Hemorragia Cerebral/induzido quimicamente , Hemorragia Cerebral/tratamento farmacológico , Vitamina K/antagonistas & inibidores , Idoso , Idoso de 80 Anos ou mais , Algoritmos , Fatores de Coagulação Sanguínea/administração & dosagem , Hemorragia Cerebral/diagnóstico por imagem , Relação Dose-Resposta a Droga , Feminino , Humanos , Masculino , Melhoria de Qualidade , Estudos Retrospectivos , Fatores de Tempo , Tomografia Computadorizada por Raios X
8.
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
9.
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
10.
Am J Emerg Med ; 38(3): 539-544, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-31176578

RESUMO

INTRODUCTION: Coagulopathy due to warfarin in patients with major bleeding was traditionally reversed with fresh frozen plasma and intravenous (IV) vitamin K, but prothrombin complex concentrates (PCC) are increasingly used in the treatment of these patients. Factor Eight Inhibitor Bypassing Activity (FEIBA) is an activated four-factor PCC most commonly used in patients with hemophilia. We aimed to evaluate the efficacy and safety of FEIBA and IV vitamin K for the reversal of warfarin-associated coagulopathy in patients with major bleeding, by measuring the percentage of patients who achieved target INR ≤ 1.5 and the incidence of thrombotic adverse events (TAE). METHODS: In this prospective observational study, we enrolled patients presenting to the Emergency Department (ED) with warfarin associated coagulopathy (INR > 1.5) and major bleeding. Patients received FEIBA using an INR based dosing strategy and IV vitamin K. RESULTS: In 43 patients, median initial INR was 4.0 (2.7, 7.3 interquartile range (IQR)). Median time to result the second INR was 45 min (38, 55 IQR) and the median INR was 1.4 (1.3, 1.6 IQR). Out of the 43 patients, 93% achieved the target INR of ≤1.5. In-hospital mortality was 40% (17 patients). There were 11 TAEs in 6 patients (14%); 4 events in 2 patients (5%) were attributed to FEIBA. CONCLUSION: A protocolized use of FEIBA and IV vitamin K resulted in the efficacious reversal of warfarin-induced coagulopathy in patients with major bleeding. TAEs occurred in 14% of patients and were attributed to FEIBA in 5% of patients.


Assuntos
Anticoagulantes/efeitos adversos , Fatores de Coagulação Sanguínea/administração & dosagem , Coagulantes/administração & dosagem , Hemorragia/tratamento farmacológico , Varfarina/efeitos adversos , Adulto , Idoso , Idoso de 80 Anos ou mais , Esquema de Medicação , Feminino , Hemorragia/induzido quimicamente , Hemorragia/mortalidade , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Vitamina K/administração & dosagem
11.
J Gastroenterol Hepatol ; 35(5): 846-854, 2020 May.
Artigo em Inglês | MEDLINE | ID: mdl-31689724

RESUMO

BACKGROUND AND AIM: To study the management of coagulation and hematological derangements among severe acute liver failure (ALF) patients in Australia and New Zealand liver transplant intensive care units (ICUs). METHODS: Analysis of key baseline characteristics, etiology, coagulation and hematological tests, use of blood products, thrombotic complications, and clinical outcomes during the first ICU week. RESULTS: We studied 62 ALF patients. The first day median peak international normalized ratio was 5.5 (inter-quartile range [IQR] 3.8-8.7), median longest activated partial thromboplastin time was 62 s (IQR 44-87), and median lowest fibrinogen was 1.1 (IQR 0.8-1.6) g/L. Fibrinogen was only measured in 85% of patients, which was less than other tests (P < 0.0001). Median initial lowest platelet count was 83 (IQR 41-122) × 109 /L. Overall, 58% of patients received fresh frozen plasma, 40% cryoprecipitate, 35% platelets, and 15% prothrombin complex concentrate. Patients with bleeding complications (19%) had more severe overall hypofibrinogenemia and thrombocytopenia. Thrombotic complications were less common (10% of patients), were not associated with consistent patterns of abnormal hemostasis, and were not immediately preceded by clotting factor administration and half occurred only after liver transplantation surgery. CONCLUSION: In ALF patients admitted to dedicated Australia and New Zealand ICUs, fibrinogen was measured less frequently than other coagulation parameters but, together with platelets, appeared more relevant to bleeding risk. Blood products and procoagulant factors were administered to most patients at variable levels of hemostatic derangement, and bleeding complications were more common than thrombotic complications. This epidemiologic information and practice variability provide baseline data for the design and powering of interventional studies.


Assuntos
Transtornos da Coagulação Sanguínea/etiologia , Fatores de Coagulação Sanguínea/administração & dosagem , Fármacos Hematológicos/administração & dosagem , Hemorragia/etiologia , Falência Hepática Aguda/etiologia , Trombose/etiologia , Adulto , Austrália/epidemiologia , Transtornos da Coagulação Sanguínea/sangue , Transtornos da Coagulação Sanguínea/epidemiologia , Testes de Coagulação Sanguínea , Feminino , Hemorragia/sangue , Hemorragia/epidemiologia , Hemostasia , Humanos , Falência Hepática Aguda/sangue , Falência Hepática Aguda/epidemiologia , Masculino , Pessoa de Meia-Idade , Nova Zelândia/epidemiologia , Trombose/sangue , Trombose/epidemiologia , Adulto Jovem
12.
J Thromb Thrombolysis ; 49(1): 121-131, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31664662

RESUMO

Andexanet-alpha is a specific reversal agent for direct factor Xa inhibitors (dFXaI). We aimed to project utilization rates and cost of andexanet for reversal of dFXaI-related major hemorrhage compared to 4-factor prothrombin complex concentrates (4F-PCC). A retrospective, multicenter review was conducted between 1/1/2014 and 7/15/2018 of patients who received 4F-PCC for reversal of dFXaI-related life-threatening hemorrhages. Total hospital reimbursements/patient were calculated based on national average MS-DRG payments adjusting for Medicare discounts. The projected cost for andexanet (based on dose and insurance) and % reimbursement/patient was compared to the actual cost of 4F-PCC. Hemostasis at 24 h (excellent/good vs. poor) and 30-day thrombotic complications were assessed. Of 126 patients who received 4F-PCC to reverse dFXaI, 46 (~ 10 per-year) met inclusion criteria. The median projected cost of andexanet was $22,120/patient, compared to $5670/patient for 4F-PCC (P < 0.001). The median hospital reimbursement was $11,492/hospitalization. The projected cost of andexanet alone would exceed the entire hospital reimbursement in 74% of patients by a median of $7604, while 4F-PCC cost exceeded the total hospital payments in 7% of patients in the same cohort (P < 0.001). Hemostasis was excellent/good in 72% of patients post-4F-PCC, compared to 82% in andexanet trials. Thromboembolic events occurred in 4% of patients following 4F-PCC versus 10% in andexanet trials. The projected cost of andexanet would exceed the national average hospital reimbursement/patient in nearly 75% of patients by over $7500/hospitalization. 4F-PCC was significantly less expensive, had lower rates of thrombosis, but also lower rates of good/excellent hemostasis compared to published data for andexanet.


Assuntos
Fatores de Coagulação Sanguínea , Inibidores do Fator Xa , Fator Xa , Hemorragia , Proteínas Recombinantes , Centros de Atenção Terciária/economia , Idoso , Idoso de 80 Anos ou mais , Fatores de Coagulação Sanguínea/administração & dosagem , Fatores de Coagulação Sanguínea/economia , Custos e Análise de Custo , Fator Xa/administração & dosagem , Fator Xa/economia , Inibidores do Fator Xa/administração & dosagem , Inibidores do Fator Xa/efeitos adversos , Inibidores do Fator Xa/economia , Feminino , Hemorragia/induzido quimicamente , Hemorragia/tratamento farmacológico , Hemorragia/economia , Hemorragia/epidemiologia , Humanos , Masculino , Proteínas Recombinantes/administração & dosagem , Proteínas Recombinantes/economia , Estudos Retrospectivos
13.
Ann Ital Chir ; 90: 421-426, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31814603

RESUMO

BACKGROUND: Non-operative management (NOM) may be particularly challenging in patients receiving synchronous antithrombotic therapy (AT). The current study examined the feasibility of NOM in patients under AT who sustained blunt splenic or hepatic injuries. METHODS: We analyzed the results of a 5-year (2010-2014) pre-decided treatment protocol, including 15 patients under AT who were treated for splenic and/or hepatic injuries at our institution. The antithrombotic therapy consisted of acenocoumarol 4 mg, acetylsalicylic acid 100 mg and clopidogrel 75 mg. Vitamin K (Vit K), Fresh frozen plasma (FFP) and Prothrombin Complex Concentrate (PCC) were transfused to patients receiving anticoagulant therapy, while platelets (PLTs) were given to patients under antiplatelet therapy if their level was excessively low. The organ injury grading scale, injury severity score (ISS), the need for blood transfusion and intensive care unit (ICU)/ high dependency unit (HDU) admission, morbidity, mortality and duration of hospital stay were also recorded. RESULTS: Ten patients fulfilled the criteria for NOM and were treated accordingly. No conversion to operative management (OM) was required (success rate 100%). Five patients were managed surgically due to hemodynamic instability and/or signs of peritonitis. Reversal of AT was attempted in all cases. CONCLUSIONS: Hemodynamically stable patients under AT with blunt hepatic or splenic injuries (grade ≤ III) and no signs of peritonitis, may be good candidates for NOM, despite their bleeding tendency. The type of AT does not seem to influence the final outcome. Reversal of AT should be stratified individually. KEY WORDS: Antithrombotic therapy, Hemodynamic stability, Non-operative management.


Assuntos
Fatores de Coagulação Sanguínea/uso terapêutico , Transfusão de Sangue , Fibrinolíticos/efeitos adversos , Hemorragia/prevenção & controle , Fígado/lesões , Plasma , Baço/lesões , Vitamina K/uso terapêutico , Ferimentos não Penetrantes/terapia , Acenocumarol/efeitos adversos , Acenocumarol/uso terapêutico , Adulto , Idoso , Idoso de 80 Anos ou mais , Aspirina/efeitos adversos , Aspirina/uso terapêutico , Fatores de Coagulação Sanguínea/administração & dosagem , Terapia Combinada , Cuidados Críticos , Gerenciamento Clínico , Estudos de Viabilidade , Feminino , Fibrinolíticos/uso terapêutico , Hemorragia/induzido quimicamente , Hemorragia/etiologia , Humanos , Escala de Gravidade do Ferimento , Tempo de Internação/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Resultado do Tratamento , Vitamina K/administração & dosagem , Ferimentos não Penetrantes/complicações , Ferimentos não Penetrantes/fisiopatologia
14.
J Am Pharm Assoc (2003) ; 59(6): 797-803, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31405805

RESUMO

OBJECTIVES: In France, only hospital pharmacies can dispense clotting factor concentrates to persons with hemophilia, which limits the access to care for the treatment and the prevention of bleeding episodes. Moreover, the cost of clotting factor concentrates may restrain the maintenance of sufficient stocks in hospital pharmacies. The aim of this study was to investigate the accessibility of clotting factor concentrates to persons with hemophilia in the context of long-term prophylaxis and emergency treatment in the Rhone-Alpes region of France. METHODS: A geographic information system was used for evaluating accessibility of clotting factor concentrates. Persons with hemophilia and hospital pharmacies were geolocalized with the use of postal data, and the evaluation of accessibility was based on the road network. RESULTS: Approximately 72% of the study area was accessible in less than 30 minutes to a hospital pharmacy. Eighty-five percent of persons with hemophilia had access to clotting factor concentrates for prophylactic treatment in less than 20 minutes. Most of them were patients with severe or moderate hemophilia. Regarding emergency doses, factor VIII was accessible in less than 30 minutes in 45.6% of the study area, and factor IX in 30.5%. CONCLUSION: This study highlights that spatial access to clotting factor concentrates by persons with hemophilia in the Rhône-Alpes region is good for prophylactic treatment but is more uneven for emergency doses.


Assuntos
Fatores de Coagulação Sanguínea/administração & dosagem , Acesso aos Serviços de Saúde , Hemofilia A/terapia , Serviço de Farmácia Hospitalar/estatística & dados numéricos , Adulto , Feminino , França , Sistemas de Informação Geográfica , Humanos , Masculino , Análise Espacial
15.
Transfus Med ; 29(4): 268-274, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31347218

RESUMO

OBJECTIVE: To evaluate the effectiveness and safety of prothrombin complex concentrates (PCCs) in approved and off-label indications. BACKGROUND: PCCs are approved for the urgent reversal of vitamin K antagonists (VKAs). Data concerning the efficacy, safety and dosing for off-label indications are limited, but they are included in massive bleeding protocols. METHODS: This was a retrospective review of cases treated with four-factor PCCs (4F-PCCs) between January 2009 and 2016. Efficacy end-points include: (i) VKA reversal efficacy assessed by international normalised ratio (INR) normalisation (<1·5) and (ii) clinical efficacy as bleeding cessation and/or decreased number of transfused blood components and 24-h mortality in bleeding coagulopathy. The safety end-point is the incidence of thromboembolic events. RESULTS: A total of 328 patients were included (51·8% male, median age 78 years old). Indications were as follows: VKA reversal (66·6%), bleeding coagulopathy (30·5%) and direct anticoagulant (DOAC) reversal due to bleeding (2·5%). VKA reversal was effective in 97·1% of patients, and 76·5% demonstrated complete reversal (INR < 1·5); only 34·3% patients needed hemoderivatives. Prior to emergency procedures, PCCs achieved global responses in 83% of patients, with no bleeding complication during intervention. DOAC reversal was effective in 88·9% of patients. Bleeding cessation was associated with the dose administered (P = 0·002). In coagulopathy bleeding, haemorrhage cessation, established by the International Society of Thrombosis and Haemostais (ISTH) definition, occurred in 56·7% of massive bleeding events and in 42·5% of other coagulopathies; 24-h mortality was 30%, mainly related to active bleeding. Ten thrombotic episodes were observed (3·1%). CONCLUSION: 4F-PCC was effective as adjuvant treatment with an acceptable safety profile, not only for the emergent reversal of VKAs but also for refractory coagulopathy associated with major bleeding.


Assuntos
Anticoagulantes/efeitos adversos , Fatores de Coagulação Sanguínea/administração & dosagem , Coagulação Intravascular Disseminada , Hemorragia , Uso Off-Label , Segurança , Vitamina K/antagonistas & inibidores , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/administração & dosagem , Fatores de Coagulação Sanguínea/efeitos adversos , Coagulação Intravascular Disseminada/sangue , Coagulação Intravascular Disseminada/tratamento farmacológico , Coagulação Intravascular Disseminada/mortalidade , Feminino , Hemorragia/sangue , Hemorragia/induzido quimicamente , Hemorragia/tratamento farmacológico , Hemorragia/mortalidade , Humanos , Incidência , Coeficiente Internacional Normatizado , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Tromboembolia/sangue , Tromboembolia/induzido quimicamente , Tromboembolia/mortalidade
16.
West J Emerg Med ; 20(4): 619-625, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31316701

RESUMO

Introduction: Warfarin is a potent anticoagulant used for the prevention and treatment of venous and arterial thrombosis. Occasionally, patients require emergent warfarin reversal due to active bleeding, supratherapeutic international normalized ratio, or emergent diagnostic or therapeutic interventions. Various agents can be used for emergent warfarin reversal, including fresh frozen plasma (FFP) and 4-factor prothrombin complex concentrate (4F-PCC). Both FFP and 4F-PCC are generally considered safe; however, both agents contain coagulation factors and have the potential to provoke a thromboembolic event. Although clinical trials have compared the efficacy and safety of FFP and 4F-PCC, data are limited comparing the risk of thromboembolism between the two agents. Methods: A retrospective chart review was performed at a single, urban, academic medical center comparing the incidence of thromboembolism with FFP or 4F-PCC for warfarin reversal during a three-year period in the emergency department (ED) at Massachusetts General Hospital. Patients were included in the study if they were at least 18 years of age and were on warfarin per electronic health records. Patients were excluded if they had received both FFP and 4F-PCC during the same visit. The primary outcome was the frequency of thromboembolism within 30 days of 4F-PCC or FFP. Secondary outcomes included time to thromboembolic event and in-hospital mortality. Results: Three hundred and thirty-six patients met the inclusion criteria. Thromboembolic events within 30 days of therapy occurred in seven patients (2.7%) in the FFP group and 14 patients (17.7%) in the 4F-PCC group (p=<0.001). Death occurred in 39 patients (15.2%) who received FFP and 18 patients (22.8%) who received 4F-PCC (p=0.115). Since the 4F-PCC group was treated disproportionately for central nervous system (CNS) bleeding, a subgroup analysis was performed including patients requiring reversal due to CNS bleeds that received vitamin K. The primary outcome remained statistically significant, occurring in four patients (4.1%) in the FFP group and nine patients (14.1%) in the 4F-PCC group (p=0.02). Conclusion: Our study found a significantly higher risk of thromboembolic events in patients receiving 4F-PCC compared to FFP for urgent warfarin reversal. This difference remained statistically significant when controlled for CNS bleeds and administration of vitamin K.


Assuntos
Fatores de Coagulação Sanguínea/efeitos adversos , Plasma , Tromboembolia/induzido quimicamente , Idoso , Anticoagulantes/efeitos adversos , Fatores de Coagulação Sanguínea/administração & dosagem , Serviço Hospitalar de Emergência , Feminino , Humanos , Masculino , Estudos Retrospectivos , Tromboembolia/epidemiologia , Varfarina/efeitos adversos
18.
BMC Anesthesiol ; 19(1): 97, 2019 06 11.
Artigo em Inglês | MEDLINE | ID: mdl-31185916

RESUMO

BACKGROUND: Most centres use fresh frozen plasma (FFP) based protocols to prevent or treat haemostatic disturbances during liver transplantation. In the present study, we used a rotational thrombelastometry (ROTEM™, TEM, Munich, Germany) guided haemostasis management with fibrinogen concentrates, prothrombin complex concentrates (PCC), platelet concentrates and tranexamic acid without FFP usage and determined the effect on 30 day mortality. METHODS: Retrospective data analysis with 372 consecutive adult liver transplant patients performed between 2007 and 2011. RESULTS: Thrombelastometry guided coagulation management resulted in a transfusion rate for fibrinogen concentrates in 50.2%, PCC in 18.8%, platelet concentrates in 21.2%, tranexamic acid in 4.5%, and red blood cell concentrates in 59.4%. 30 day mortality for the whole cohort was 14.2%. The univariate analyses indicated that nonsurvivors received significantly more fibrinogen concentrates, PCC, red blood cell concentrates, platelet concentrates, and infusion volume, and had a higher MELD score. However, association with mortality was weak as evidenced by receiver operating characteristic curve analyses. Further univariate analyses demonstrated, that up to 8 g of fibrinogen did not increase mortality compared to patients not receiving the coagulation factor. Multivariate analysis demonstrated that platelet concentrates (p = 0.0002, OR 1.87 per unit), infused volume (p = 0.0004, OR = 1.13 per litre), and MELD score (p = 0.024; OR 1.039) are independent predictors for mortality. Fibrinogen concentrates, PCC, and red blood cell concentrates were ruled out as independent risk factors. CONCLUSIONS: ROTEM™ guided substitution with fibrinogen concentrates and PCC does not negatively affect mortality after liver transplantation, while the well-known deleterious effect associated with platelet concentrates was confirmed.


Assuntos
Fatores de Coagulação Sanguínea/metabolismo , Coagulação Sanguínea/fisiologia , Hemostáticos/sangue , Transplante de Fígado/mortalidade , Transplante de Fígado/métodos , Rotação , Adolescente , Adulto , Idoso , Antifibrinolíticos/administração & dosagem , Antifibrinolíticos/sangue , Coagulação Sanguínea/efeitos dos fármacos , Fatores de Coagulação Sanguínea/administração & dosagem , Plaquetas/metabolismo , Criança , Feminino , Fibrinogênio/administração & dosagem , Fibrinogênio/metabolismo , Hemostasia/efeitos dos fármacos , Hemostasia/fisiologia , Hemostáticos/administração & dosagem , Humanos , Transplante de Fígado/efeitos adversos , Transplante de Fígado/tendências , Masculino , Pessoa de Meia-Idade , Mortalidade/tendências , Estudos Retrospectivos , Tromboelastografia/efeitos adversos , Tromboelastografia/métodos , Ácido Tranexâmico/administração & dosagem , Ácido Tranexâmico/sangue , Adulto Jovem
19.
Expert Rev Hematol ; 12(7): 525-540, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-31159607

RESUMO

Introduction: Current guidelines recommend the administration of prothrombin complex concentrate in combination with vitamin K for normalization of coagulation in patients presenting with vitamin K antagonist-associated major bleeding, but until recently no adequately powered comparative trials had been conducted to support these recommendations. In this article, the authors review the evidence from studies assessing prothrombin complex concentrate treatment in these patients. Areas covered: A PubMed search (spanning January 1900 to September 2018) was conducted using the following search terms: prothrombin complex concentrate* AND (warfarin or (vitamin K antagonist*)), and papers relevant to major hemorrhagic events were identified; results from studies that used a randomized controlled trial (RCT) or a prospective design are presented here. Overall, the identified studies support the current guideline recommendations and indicate that prothrombin complex concentrates have at least similar safety profiles to other treatment options, such as fresh frozen plasma and recombinant activated factor VII. Expert opinion: It is hoped that the results from studies discussed here will inform future guideline updates; however, local clinical practice may also occasionally act as a barrier to adoption of guideline recommendations. There is an urgent need for further RCTs/prospective trials directly comparing PCC and plasma administration in acute bleeding settings.


Assuntos
Anticoagulantes/efeitos adversos , Fatores de Coagulação Sanguínea/uso terapêutico , Hemorragia/etiologia , Hemorragia/terapia , Vitamina K/antagonistas & inibidores , Fatores de Coagulação Sanguínea/administração & dosagem , Fatores de Coagulação Sanguínea/efeitos adversos , Gerenciamento Clínico , Prova Pericial , Hemorragia/diagnóstico , Humanos , Plasma , Resultado do Tratamento
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