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1.
Neurosurg Focus ; 55(4): E2, 2023 10.
Artigo em Inglês | MEDLINE | ID: mdl-37778038

RESUMO

OBJECTIVE: Although oral anticoagulant use has been implicated in worse outcomes for patients with a traumatic brain injury (TBI), prior studies have mostly examined the use of vitamin K antagonists (VKAs). In an era of increasing use of direct oral anticoagulants (DOACs) in lieu of VKAs, the authors compared the survival outcomes of TBI patients on different types of premorbid anticoagulation medications with those of patients not on anticoagulation. METHODS: The authors retrospectively reviewed the records of 1186 adult patients who presented at a level I trauma center with an intracranial hemorrhage after blunt trauma between 2016 and 2022. Patient demographics; comorbidities; and pre-, peri-, and postinjury characteristics were compared based on premorbid anticoagulation use. Multivariable Cox proportional hazards regression modeling of mortality was performed to adjust for risk factors that met a significance threshold of p < 0.1 on bivariate analysis. RESULTS: Of 1186 patients with a traumatic intracranial hemorrhage, 49 (4.1%) were taking DOACs and 53 (4.5%) used VKAs at the time of injury. Patients using oral anticoagulants were more likely to be older (p < 0.001), to have a higher Charlson Comorbidity Index (p < 0.001), and to present with a higher Glasgow Coma Scale (GCS) score (p < 0.001) and lower Injury Severity Score (ISS; p < 0.001) than those on no anticoagulation. Patients using VKAs were more likely to undergo reversal than patients using DOACs (53% vs 31%, p < 0.001). Cox proportional hazards regression demonstrated significantly increased hazard ratios (HRs) for VKA use (HR 2.204, p = 0.003) and DOAC use (HR 1.973, p = 0.007). Increasing age (HR 1.040, p < 0.001), ISS (HR 1.017, p = 0.01), and Marshall score (HR 1.186, p < 0.001) were associated with an increased risk of death. A higher GCS score on admission was associated with a decreased risk of death (HR 0.912, p < 0.001). CONCLUSIONS: Patients with a traumatic intracranial injury who were on oral anticoagulant therapy before injury demonstrated higher mortality rates than patients who were not on oral anticoagulation after adjusting for age, comorbid conditions, and injury presentation.


Assuntos
Lesões Encefálicas Traumáticas , Hemorragia Intracraniana Traumática , Adulto , Humanos , Anticoagulantes/uso terapêutico , Estudos Retrospectivos , Hemorragia Intracraniana Traumática/complicações , Hemorragia Intracraniana Traumática/tratamento farmacológico , Hemorragias Intracranianas/tratamento farmacológico , Hemorragias Intracranianas/complicações , Lesões Encefálicas Traumáticas/complicações , Lesões Encefálicas Traumáticas/tratamento farmacológico , Fatores de Risco , Vitamina K
2.
Am J Health Syst Pharm ; 80(23): 1722-1728, 2023 11 22.
Artigo em Inglês | MEDLINE | ID: mdl-37688311

RESUMO

PURPOSE: Apixaban is a direct-acting oral anticoagulant that selectively inhibits factor Xa. Reversal strategies utilized to treat factor Xa inhibitor-associated bleeding include andexanet alfa, prothrombin complex -concentrate (PCC), and activated PCC (aPCC). The optimal treatment of traumatic intracranial hemorrhage in the setting of an apixaban overdose is unknown. SUMMARY: This case report describes a 69-year-old female who initially presented to an emergency department at a community hospital due to a ground-level fall with traumatic intracranial hemorrhage. The patient reportedly ingested apixaban 275 mg, carvedilol 250 mg, atorvastatin 1,200 mg, and unknown amounts of amlodipine and ethanol. Anti-inhibitor coagulant complex, an aPCC, was administered approximately 3 hours after presentation. Initial thromboelastography performed approximately 4 hours after presentation showed a prolonged reaction time of 16.8 minutes. Ongoing imaging and evidence of coagulopathy prompted repeated aPCC administration to a cumulative dose of approximately 100 U/kg. The patient underwent craniotomy with hematoma evacuation. Postoperative imaging showed expansion of the existing intracranial hemorrhage and new areas of hemorrhage. Andexanet alfa was administered approximately 18 hours after presentation, followed by repeat craniotomy with evacuation of the hematoma. No further expansion of the intracranial hemorrhage was observed, and the reaction time on thromboelastography was normalized at 6.3 minutes. CONCLUSION: This case suggests that andexanet alfa may have a role in the management of traumatic hemorrhage in the setting of an acute massive apixaban overdose. Use of andexanet alfa, PCC, and aPCC in this context requires further research.


Assuntos
Overdose de Drogas , Hemorragia Intracraniana Traumática , Feminino , Humanos , Idoso , Fator Xa/farmacologia , Fator Xa/uso terapêutico , Hemorragia/tratamento farmacológico , Hemorragias Intracranianas/tratamento farmacológico , Hemorragia Intracraniana Traumática/tratamento farmacológico , Inibidores do Fator Xa/uso terapêutico , Overdose de Drogas/complicações , Overdose de Drogas/tratamento farmacológico , Hematoma/tratamento farmacológico , Proteínas Recombinantes/uso terapêutico , Anticoagulantes/uso terapêutico , Rivaroxabana/uso terapêutico
3.
Neurosurg Rev ; 46(1): 166, 2023 Jul 06.
Artigo em Inglês | MEDLINE | ID: mdl-37410188

RESUMO

A large number of patients who sustain a traumatic intracranial haemorrhage (tICH) are taking anti-thrombotic (AT) medications at the time of injury. These are stopped acutely, but there is uncertainty about safe timing for recommencement. This review aimed to understand the rate of new/progressive haemorrhage, thrombosis, and death in tICH patients on ATs and the rate and timing of AT recommencement. A systematic review of OVID Medline and EMBASE from 2000 to 2021 including adult patients with tICH on ATs with reported outcomes was performed. A total of 59 observational studies (20,421 patients) were included. Most patients were elderly (mean age 74), suffering falls (78%), and had a mild head injury. The mean new/progressive haemorrhage rate during admission was 26%, mostly diagnosed on routine imaging performed within 72 h of injury, with only 8% clinically significant. Thrombotic events were reported in 17 studies; mean rate of 3% during admission, 4-9% at 30 days and 3-11% at 6 months. AT recommencement rate and timing were only reported in six studies and varied widely, with some studies demonstrating reduced thrombotic events and mortality with earlier AT recommencement. Current data is observational and sparse in relation to haemorrhage, thrombosis, and AT recommencement. There is some suggestion that early recommencement, within 7-14 days, may be beneficial but higher quality studies with more consistent data are urgently required.


Assuntos
Traumatismos Craniocerebrais , Hemorragia Intracraniana Traumática , Trombose , Adulto , Humanos , Idoso , Hemorragia Intracraniana Traumática/tratamento farmacológico , Hospitalização , Hemorragia , Estudos Retrospectivos
4.
J Emerg Med ; 64(1): 1-13, 2023 01.
Artigo em Inglês | MEDLINE | ID: mdl-36658008

RESUMO

BACKGROUND: Assessing the risk of intracranial hemorrhage (ICH) in patients with a mild traumatic brain injury (MTBI) who are taking direct oral anticoagulants (DOACs) is challenging. Currently, extensive use of computed tomography (CT) is routine in the emergency department (ED). OBJECTIVE: This study aims to investigate whether the clinical and laboratory characteristics presented at the ED evaluation can also estimate the risk of post-traumatic ICH in DOAC-treated patients with MTBI. METHODS: A retrospective observational study was conducted in three EDs in Italy from January 1, 2016 to March 15, 2020. All patients treated with DOACs who were evaluated for an MTBI in the ED were enrolled. The primary outcome of the study was the presence of post-traumatic ICH in the head CT performed in the ED. RESULTS: Of 930 patients on DOACs with MTBI who were enrolled, 6.8% (63 of 930) had a post-traumatic ICH and 1.5% (14 of 930) were treated with surgery or died as a result of the ICH. None of the laboratory factors were associated with an increased risk of ICH. On multivariate analysis, previous neurosurgical intervention, major trauma dynamic, post-traumatic loss of consciousness, post-traumatic amnesia, Glasgow Coma Scale score of 14, and evidence of trauma above the clavicles were associated with a higher risk of post-traumatic ICH. The net clinical benefit provided by risk factor assessment appears superior to the strategy of performing CT on all DOAC-treated patients. CONCLUSIONS: Assessment of the clinical characteristics presented at ED admission can help identify DOAC-treated patients with MTBI who are at risk of ICH.


Assuntos
Concussão Encefálica , Hemorragia Intracraniana Traumática , Humanos , Concussão Encefálica/terapia , Anticoagulantes/uso terapêutico , Hemorragia Intracraniana Traumática/complicações , Hemorragia Intracraniana Traumática/tratamento farmacológico , Hemorragias Intracranianas/etiologia , Fatores de Risco , Estudos Retrospectivos
5.
J Neurol Surg A Cent Eur Neurosurg ; 84(4): 377-385, 2023 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-35158390

RESUMO

BACKGROUND: Traumatic intracranial hemorrhage (TICH) and its progression have historically resulted in poor prognosis and functional disability. Such outcomes can impact the daily lives and financial condition of patients' families as well as add burden to the health care system. This review examines the diverse therapeutic intervention that were observed in randomized clinical trials (RCT) on various outcomes. Many demographic and clinical risk factors have been identified for poor prognosis after a TICH. Among the many therapeutic strategies studied, few found to have some beneficial effect in minimizing the progression of hemorrhage and reducing the overall mortality. METHODS: A literature review was conducted of all relevant sources using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines to include articles that were RCTs for patients aged 18 years and above to include a total of 19 articles. RESULTS: Across studies, many therapies have been assessed; however, only few findings including infusion of tranexamic acid (TXA), use of ß-blocker, and early operative evacuation of TICH yielded favorable results. Use of steroid and blood transfusion to target higher hemoglobin levels showed evidence of adversely impacting the outcome. CONCLUSION: Of the many therapeutic strategies available for TICH, very few therapies have proven to be beneficial.


Assuntos
Hemorragia Intracraniana Traumática , Ácido Tranexâmico , Humanos , Hemorragia Intracraniana Traumática/cirurgia , Hemorragia Intracraniana Traumática/tratamento farmacológico , Hemorragia , Ácido Tranexâmico/uso terapêutico , Fatores de Risco
6.
Emerg Med J ; 39(3): 220-223, 2022 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-34158388

RESUMO

INTRODUCTION: Patients aged 60 or over account for over half of the severely injured trauma patients and a traumatic brain injury is the most common injury sustained. Many of these patients are taking antiplatelet medications but there is clinical equipoise about the role of platelet transfusion in patients with traumatic intracranial haemorrhage (ICH) taking prior antiplatelet medications. METHOD: A prepiloted survey was designed to explore a range of clinical issues in managing patients taking antiplatelet medications admitted with a traumatic brain injury. This was sent via email to consultants and specialty registrar members of a variety of relevant UK societies and working groups in the fields of emergency medicine, critical care, neurosurgery and haematology. RESULTS: 193 responses were received, mostly from colleagues in emergency medicine, neurosurgery, anaesthesia and haematology. Respondents indicated that there is a lack of evidence to support the use of platelet transfusion in this patient population but also lack of evidence of harm. Results also demonstrate uncertainties as to whether platelets should be given to all or some patients and doubt regarding the value of viscoelastic testing. DISCUSSION: Our survey demonstrates equipoise in current practice with regards to platelet transfusion in patients with a traumatic ICH who are taking antiplatelet medication. There is support for additional trials to investigate the effect of platelet transfusion in this rising population of older, high-risk patients, in order to provide a better evidence-base for guideline development.


Assuntos
Traumatismos Craniocerebrais , Hemorragia Intracraniana Traumática , Traumatismos Craniocerebrais/tratamento farmacológico , Humanos , Hemorragia Intracraniana Traumática/induzido quimicamente , Hemorragia Intracraniana Traumática/tratamento farmacológico , Pessoa de Meia-Idade , Inibidores da Agregação Plaquetária/efeitos adversos , Transfusão de Plaquetas/métodos , Estudos Retrospectivos , Inquéritos e Questionários
7.
Pharmacotherapy ; 41(6): 501-507, 2021 06.
Artigo em Inglês | MEDLINE | ID: mdl-33866591

RESUMO

STUDY OBJECTIVES: Current neurocritical care guidelines recommend 50 IU/kg four-factor prothrombin complex concentrate (4PCC) for factor Xa inhibitor (FXaI) reversal in intracranial hemorrhage (ICH) based on few clinical studies conducted among non-ICH subjects. Two recent studies suggest that low-dose (25 IU/kg) 4PCC may be similar to 50 IU/kg in reversal of FXaI in ICH, and both 25 and 50 IU/kg doses are used in clinical practice for this indication. To our knowledge, no studies have directly compared 25 IU/kg versus 50 IU/kg 4PCC for FXaI reversal in ICH. The purpose of this study is to determine whether there is a difference in hemostatic efficacy between 25 IU/kg versus 50 IU/kg 4PCC for FXaI reversal in ICH. DESIGN: This multicenter, retrospective cohort study was performed in five hospitals in central Texas from November 2013 to December 2019. DATA SOURCE: Patients were identified with a medication use report of 4PCC and were classified in the low- or standard-dose group based on whether the 25 IU/kg or 50 IU/kg dose was received, respectively. PATIENTS: A total of 93 patients were included (25 IU/kg, n = 62; 50 IU/kg, n = 31). MEASUREMENTS AND MAIN RESULTS: There was no difference in hemostatic efficacy between groups (82.3% low dose vs. 83.9% standard dose, p = 0.846). No differences were identified in-hospital mortality, length of stay, thrombotic events, or the need for surgery or additional blood products between groups. CONCLUSION: For the reversal of FXaI in ICH, a 25 IU/kg dose may be an effective alternative to 50 IU/kg 4PCC dosing.


Assuntos
Fatores de Coagulação Sanguínea , Inibidores do Fator Xa , Hemorragias Intracranianas , Fatores de Coagulação Sanguínea/administração & dosagem , Relação Dose-Resposta a Droga , Inibidores do Fator Xa/efeitos adversos , Humanos , Hemorragia Intracraniana Traumática/induzido quimicamente , Hemorragia Intracraniana Traumática/tratamento farmacológico , Hemorragias Intracranianas/induzido quimicamente , Hemorragias Intracranianas/tratamento farmacológico , Estudos Retrospectivos
8.
Acta Neurochir (Wien) ; 163(5): 1391-1401, 2021 05.
Artigo em Inglês | MEDLINE | ID: mdl-33759013

RESUMO

BACKGROUND: The role of coagulopathy in patients with traumatic brain injury has remained elusive. In the present study, we aim to assess the prevalence of coagulopathy in patients with traumatic intracranial hemorrhage, their clinical features, and the effect of coagulopathy on treatment and mortality. METHODS: An observational, retrospective single-center cohort of consecutive patients with traumatic intracranial hemorrhage treated at Helsinki University Hospital between 01 January and 31 December 2010. We compared clinical and radiological parameters in patients with and without coagulopathy defined as drug- or disease-induced, i.e., antiplatelet or anticoagulant medication at a therapeutic dose, thrombocytopenia (platelet count < 100 E9/L), international normalized ratio > 1.2, or thromboplastin time < 60%. Primary outcome was 30-day all-cause mortality. Logistic regression analysis allowed to assess for factors associated with coagulopathy and mortality. RESULTS: Of our 505 patients (median age 61 years, 65.5% male), 206 (40.8%) had coagulopathy. Compared to non-coagulopathy patients, coagulopathy patients had larger hemorrhage volumes (mean 140.0 mL vs. 98.4 mL, p < 0.001) and higher 30-day mortality (18.9% vs. 9.7%, p = 0.003). In multivariable analysis, older age, lower admission Glasgow Coma Scale score, larger hemorrhage volume, and conservative treatment were independently associated with mortality. Surgical treatment was associated with lower mortality in both patients with and without coagulopathy. CONCLUSIONS: Coagulopathy was more frequent in patients with traumatic intracranial hemorrhage presenting larger hemorrhage volumes compared to non-coagulopathy patients but was not independently associated with higher 30-day mortality. Hematoma evacuation, in turn, was associated with lower mortality irrespective of coagulopathy.


Assuntos
Transtornos da Coagulação Sanguínea/complicações , Hemorragia Intracraniana Traumática/tratamento farmacológico , Hemorragia Intracraniana Traumática/mortalidade , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/uso terapêutico , Transtornos da Coagulação Sanguínea/epidemiologia , Feminino , Escala de Coma de Glasgow , Humanos , Hemorragia Intracraniana Traumática/complicações , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Estudos Retrospectivos
9.
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
10.
J Clin Neurosci ; 79: 197-202, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-33070895

RESUMO

OBJECTIVE: Administration of prothrombin complex concentrate (PCC) is recommended for vitamin K antagonist (VKA) reversal in patients with severe bleeding complications. However, there are only limited data available on its use for VKA reversal in patients with traumatic intracranial hemorrhage (ICH). METHODS: Data from all anticoagulated patients referred to our hospital for treatment of traumatic ICH and who received PCC for anticoagulation reversal were retrospectively analysed with specific focus on bleeding and thromboembolic complications during the further in-hospital course. RESULTS: A total of 142 patients were included in the present study. The median age was 78 years (Interquartile range [IQR]: 72-84) and the median Glasgow Coma Scale (GCS) score on admission was 12 (IQR: 7-14). Median International Normalized Ratio (INR) on admission was 2.5 [IQR: 2.0-3.3] and decreased to 1.2 [IQR: 1.1-1.3] following administration of a median dose of 2000 I.U. PCC [IQR: 1500-2625]. The in-hospital mortality rate was 13% and the median GCS of survivors at discharge was 14 [IQR: 12-15]. Thromboembolic events after PCC administration occurred in 4 patients (2.8%). The overall one-year mortality rate in this patient cohort was 49%. CONCLUSIONS: PCC administration rapidly normalises INR and facilitates urgent neurosurgical procedures in anticoagulated patients with traumatic ICH.


Assuntos
Fatores de Coagulação Sanguínea/uso terapêutico , Hemorragia Intracraniana Traumática/tratamento farmacológico , Idoso , Anticoagulantes/efeitos adversos , Coagulação Sanguínea , Fatores de Coagulação Sanguínea/administração & dosagem , Feminino , Escala de Coma de Glasgow , Humanos , Hemorragia Intracraniana Traumática/sangue , Hemorragia Intracraniana Traumática/patologia , Pessoa de Meia-Idade , Resultado do Tratamento
12.
J Head Trauma Rehabil ; 35(5): 317-323, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32881765

RESUMO

OBJECTIVE: To evaluate the effect of early tranexamic acid (TXA) administration on circulating markers of endotheliopathy. SETTING: Twenty trauma centers in the United States and Canada. PARTICIPANTS: Patients with moderate-to-severe traumatic brain injury (TBI) (MS-TBI) and intracranial hemorrhage who were not in shock (systolic blood pressure ≥90 mm Hg). DESIGN: TXA (2 g) or placebo administered prior to hospital arrival, less than 2 hours postinjury. Blood samples and head computed tomographic scan collected upon arrival. Plasma markers measured using Luminex analyte platform. Differences in median marker levels evaluated using t tests performed on log-transformed variables. Comparison groups were TXA versus placebo and less than 45 minutes versus 45 minutes or more from time of injury to treatment administration. MAIN MEASURES: Plasma levels of angiopoietin-1, angiopoietin-2, syndecan-1, thrombomodulin, thrombospondin-2, intercellular adhesion molecule 1, vascular adhesion molecule 1. RESULTS: Demographics and Injury Severity Score were similar between the placebo (n = 129) and TXA (n = 158) groups. Levels of syndecan-1 were lower in the TXA group (median [interquartile range or IQR] = 254.6 pg/mL [200.7-322.0] vs 272.4 pg/mL [219.7-373.1], P = .05. Patients who received TXA less than 45 minutes postinjury had significantly lower levels of angiopoietin-2 (median [IQR] = 144.3 pg/mL [94.0-174.3] vs 154.6 pg/mL [110.4-209.8], P = .05). No differences were observed in remaining markers. CONCLUSIONS: TXA may inhibit early upregulation of syndecan-1 and angiopoietin-2 in patients with MS-TBI, suggesting attenuation of protease-mediated vascular glycocalyx breakdown. The findings of this exploratory analysis should be considered preliminary and require confirmation in future studies.


Assuntos
Angiopoietina-2/sangue , Antifibrinolíticos , Lesões Encefálicas Traumáticas , Hemorragia Intracraniana Traumática , Sindecana-1/sangue , Ácido Tranexâmico , Adulto , Antifibrinolíticos/uso terapêutico , Lesões Encefálicas Traumáticas/complicações , Lesões Encefálicas Traumáticas/diagnóstico , Lesões Encefálicas Traumáticas/tratamento farmacológico , Método Duplo-Cego , Feminino , Humanos , Hemorragia Intracraniana Traumática/tratamento farmacológico , Masculino , Pessoa de Meia-Idade , Ácido Tranexâmico/uso terapêutico , Estados Unidos
13.
World Neurosurg ; 142: e95-e100, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32561488

RESUMO

BACKGROUND: Andexanet alfa, a novel anticoagulation reversal agent for factor Xa inhibitors, was recently approved. Traumatic intracranial hemorrhage presents a prime target for this drug. The Novel Antidote to the Anticoagulation Effects of Factor Xa Inhibitors study established the efficacy of andexanet alfa in reversing factor Xa inhibitors. However, the association between anticoagulation reversal and traumatic intracranial hemorrhage progression is not well understood. The objective of this study was to determine progression rates of patients with traumatic intracranial hemorrhage on factor Xa inhibitors prior to hospitalization who were managed without the use of andexanet alfa. METHODS: A retrospective cohort study was performed between 2016 and 2019 at a single institution. An institutional traumatic brain injury (TBI) registry was queried. Patients with recorded use of apixaban or rivaroxaban <18 hours before injury were included. The primary study outcome was <35% increase in hemorrhage volume or thickness on repeated head computed tomography (CT) scans. RESULTS: We identified 25 patients meeting the inclusion criteria. Two patients were excluded because of a lack of necessary CT data. Twelve patients (52%) were receiving apixaban, and 11 were (48%) on rivaroxaban. On admission CT scan, 14 patients had subdural hematoma, 6 had traumatic intraparenchymal hemorrhage, and 3 had subarachnoid hemorrhage. Anticoagulation reversal was attempted in 17 patients (74%), primarily using 4-factor prothrombin complex concentrate. Twenty patients (87%) were adjudicated as having excellent or good hemostasis on repeat imaging. CONCLUSIONS: Our results indicate that patients on factor Xa inhibitors with complicated mild TBI have a similar intracranial hemorrhage progression rate to patients who are not anticoagulated or anticoagulated with a reversible agent. The hemostatic outcomes in our cohort were similar to those reported after andexanet alfa administration.


Assuntos
Fatores de Coagulação Sanguínea/uso terapêutico , Inibidores do Fator Xa/efeitos adversos , Fator Xa/uso terapêutico , Hemorragia Intracraniana Traumática/tratamento farmacológico , Proteínas Recombinantes/uso terapêutico , Idoso , Idoso de 80 Anos ou mais , Fibrilação Atrial/tratamento farmacológico , Hemorragia Cerebral Traumática/diagnóstico por imagem , Hemorragia Cerebral Traumática/tratamento farmacológico , Hemorragia Cerebral Traumática/fisiopatologia , Estudos de Coortes , Progressão da Doença , Inibidores do Fator Xa/uso terapêutico , Feminino , Escala de Coma de Glasgow , Hematoma Subdural Intracraniano/diagnóstico por imagem , Hematoma Subdural Intracraniano/tratamento farmacológico , Hematoma Subdural Intracraniano/fisiopatologia , Hemostasia , Humanos , Hemorragia Intracraniana Traumática/diagnóstico por imagem , Hemorragia Intracraniana Traumática/fisiopatologia , Masculino , Pessoa de Meia-Idade , Plasma , Transfusão de Plaquetas , Pirazóis/efeitos adversos , Pirazóis/uso terapêutico , Piridonas/efeitos adversos , Piridonas/uso terapêutico , Estudos Retrospectivos , Risco , Fatores de Risco , Rivaroxabana/efeitos adversos , Rivaroxabana/uso terapêutico , Hemorragia Subaracnoídea Traumática/diagnóstico por imagem , Hemorragia Subaracnoídea Traumática/tratamento farmacológico , Hemorragia Subaracnoídea Traumática/fisiopatologia , Tomografia Computadorizada por Raios X , Tromboembolia Venosa/tratamento farmacológico , Tromboembolia Venosa/prevenção & controle
14.
Lancet ; 394(10210): 1713-1723, 2019 11 09.
Artigo em Inglês | MEDLINE | ID: mdl-31623894

RESUMO

BACKGROUND: Tranexamic acid reduces surgical bleeding and decreases mortality in patients with traumatic extracranial bleeding. Intracranial bleeding is common after traumatic brain injury (TBI) and can cause brain herniation and death. We aimed to assess the effects of tranexamic acid in patients with TBI. METHODS: This randomised, placebo-controlled trial was done in 175 hospitals in 29 countries. Adults with TBI who were within 3 h of injury, had a Glasgow Coma Scale (GCS) score of 12 or lower or any intracranial bleeding on CT scan, and no major extracranial bleeding were eligible. The time window for eligibility was originally 8 h but in 2016 the protocol was changed to limit recruitment to patients within 3 h of injury. This change was made blind to the trial data, in response to external evidence suggesting that delayed treatment is unlikely to be effective. We randomly assigned (1:1) patients to receive tranexamic acid (loading dose 1 g over 10 min then infusion of 1 g over 8 h) or matching placebo. Patients were assigned by selecting a numbered treatment pack from a box containing eight packs that were identical apart from the pack number. Patients, caregivers, and those assessing outcomes were masked to allocation. The primary outcome was head injury-related death in hospital within 28 days of injury in patients treated within 3 h of injury. We prespecified a sensitivity analysis that excluded patients with a GCS score of 3 and those with bilateral unreactive pupils at baseline. All analyses were done by intention to treat. This trial was registered with ISRCTN (ISRCTN15088122), ClinicalTrials.gov (NCT01402882), EudraCT (2011-003669-14), and the Pan African Clinical Trial Registry (PACTR20121000441277). RESULTS: Between July 20, 2012, and Jan 31, 2019, we randomly allocated 12 737 patients with TBI to receive tranexamic acid (6406 [50·3%] or placebo [6331 [49·7%], of whom 9202 (72·2%) patients were treated within 3 h of injury. Among patients treated within 3 h of injury, the risk of head injury-related death was 18·5% in the tranexamic acid group versus 19·8% in the placebo group (855 vs 892 events; risk ratio [RR] 0·94 [95% CI 0·86-1·02]). In the prespecified sensitivity analysis that excluded patients with a GCS score of 3 or bilateral unreactive pupils at baseline, the risk of head injury-related death was 12·5% in the tranexamic acid group versus 14·0% in the placebo group (485 vs 525 events; RR 0·89 [95% CI 0·80-1·00]). The risk of head injury-related death reduced with tranexamic acid in patients with mild-to-moderate head injury (RR 0·78 [95% CI 0·64-0·95]) but not in patients with severe head injury (0·99 [95% CI 0·91-1·07]; p value for heterogeneity 0·030). Early treatment was more effective than was later treatment in patients with mild and moderate head injury (p=0·005) but time to treatment had no obvious effect in patients with severe head injury (p=0·73). The risk of vascular occlusive events was similar in the tranexamic acid and placebo groups (RR 0·98 (0·74-1·28). The risk of seizures was also similar between groups (1·09 [95% CI 0·90-1·33]). INTERPRETATION: Our results show that tranexamic acid is safe in patients with TBI and that treatment within 3 h of injury reduces head injury-related death. Patients should be treated as soon as possible after injury. FUNDING: National Institute for Health Research Health Technology Assessment, JP Moulton Charitable Trust, Department of Health and Social Care, Department for International Development, Global Challenges Research Fund, Medical Research Council, and Wellcome Trust (Joint Global Health Trials scheme). TRANSLATIONS: For the Arabic, Chinese, French, Hindi, Japanese, Spanish and Urdu translations of the abstract see Supplementary Material.


Assuntos
Antifibrinolíticos/administração & dosagem , Lesões Encefálicas Traumáticas/complicações , Hemorragia Intracraniana Traumática/tratamento farmacológico , Ácido Tranexâmico/administração & dosagem , Adulto , Idoso , Antifibrinolíticos/efeitos adversos , Lesões Encefálicas Traumáticas/tratamento farmacológico , Lesões Encefálicas Traumáticas/mortalidade , Esquema de Medicação , Feminino , Humanos , Análise de Intenção de Tratamento , Cooperação Internacional , Hemorragia Intracraniana Traumática/mortalidade , Masculino , Pessoa de Meia-Idade , Índice de Gravidade de Doença , Análise de Sobrevida , Tempo para o Tratamento , Ácido Tranexâmico/efeitos adversos , Resultado do Tratamento , Doenças Vasculares/epidemiologia , Doenças Vasculares/etiologia , Adulto Jovem
15.
World Neurosurg ; 125: e665-e670, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-30721773

RESUMO

BACKGROUND: Fall with head injury is a pervasive challenge, especially in the aging population. Contributing factors for mortality include the development of cerebral contusions and delayed traumatic intracerebral hematoma. Currently, there is no established specific treatment for these conditions. OBJECT: This study aimed to investigate the impact of independent factors on the mortality rate of traumatic brain injury with contusions or traumatic subarachnoid hemorrhage. METHODS: Data were collected from consecutive patients admitted for cerebral contusions or traumatic subarachnoid hemorrhage at an academic trauma center from 2010 to 2016. The primary outcome was the 30-day mortality rate. Independent factors for analysis included patient factors and treatment modalities. Univariate and multivariate analyses were conducted to identify independent factors related to mortality. Secondary outcomes included thromboembolic complication rates associated with the use of tranexamic acid. RESULTS: In total, 651 consecutive patients were identified. For the patient factors, low Glasgow Coma Scale on admission, history of renal impairment, and use of warfarin were identified as independent factors associated with higher mortality from univariate and multivariate analyses. For the treatment modalities, univariate analysis identified tranexamic acid as an independent factor associated with lower mortality (P = 0.021). Thromboembolic events were comparable in patients with or without tranexamic acid. CONCLUSION: Tranexamic acid was identified by univariate analysis as an independent factor associated with lower mortality in cerebral contusions or traumatic subarachnoid hemorrhage. Further prospective studies are needed to validate this finding.


Assuntos
Contusão Encefálica/tratamento farmacológico , Contusão Encefálica/mortalidade , Hemorragia Subaracnoídea Traumática/mortalidade , Ácido Tranexâmico/farmacologia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Hemorragia Cerebral Traumática/tratamento farmacológico , Hemorragia Cerebral Traumática/mortalidade , Feminino , Humanos , Hemorragia Intracraniana Traumática/tratamento farmacológico , Hemorragia Intracraniana Traumática/mortalidade , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Hemorragia Subaracnoídea Traumática/cirurgia , Adulto Jovem
16.
Am J Emerg Med ; 37(10): 1907-1911, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-30651183

RESUMO

OBJECTIVE: The objective of this study was to determine the effectiveness and safety of four-factor prothrombin complex concentrate (4F-PCC) for the reversal of factor Xa inhibitors in patients with traumatic intracranial hemorrhage (ICH). METHODS: This was a retrospective cohort study of patients taking factor Xa inhibitors with traumatic ICH between March 1, 2015 and August 31, 2017 at two trauma centers. The primary outcome was in-hospital mortality in patients who received 4F-PCC (4F-PCC group) compared to those who did not (no reversal group). Secondary outcomes included functional recovery, hospital and intensive care unit (ICU) length of stay (LOS), and thromboembolic complications. RESULTS: There were 62 patients included in the study. Injury Severity Score (ISS) was significantly higher in the 4F-PCC group (17.6 vs. 12.1, p = 0.019). The 4F-PCC group had a significantly higher mortality (22.9% vs. 3.7%, p = 0.034) and longer ICU LOS (2.5 vs. 1.4 days, p = 0.0024). The no reversal group had a significantly higher incidence of ischemic stroke/transient ischemic attack (TIA) (0% vs. 14.8%, p = 0.019). After controlling for ISS, there was no significant difference in mortality (p = 0.20), ICU LOS (p = 0.64), or ischemic stroke/TIA (p = 0.94). There was no difference in hospital LOS, discharge disposition, final Activity Measure for Post Acute Care daily activity score, VTE, or MI. CONCLUSION: Patients with a higher ISS received 4F-PCC preferentially, which led to an apparent mortality benefit the no reversal group. After adjusting for baseline differences between groups, there was no difference in mortality, functional recovery, hospital and ICU LOS, or thromboembolic complications.


Assuntos
Fatores de Coagulação Sanguínea/uso terapêutico , Inibidores do Fator Xa/efeitos adversos , Hemorragia Intracraniana Traumática/tratamento farmacológico , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Mortalidade Hospitalar , Humanos , Hemorragia Intracraniana Traumática/etiologia , Hemorragia Intracraniana Traumática/mortalidade , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Resultado do Tratamento
17.
World Neurosurg ; 123: e25-e30, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30528524

RESUMO

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


Assuntos
Anticoagulantes/administração & dosagem , Hemorragia Intracraniana Traumática/tratamento farmacológico , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Enoxaparina/administração & dosagem , Feminino , Heparina/administração & dosagem , Humanos , Hemorragia Intracraniana Traumática/cirurgia , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Resultado do Tratamento , Varfarina/administração & dosagem , Adulto Jovem
18.
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
19.
Trials ; 18(1): 330, 2017 07 17.
Artigo em Inglês | MEDLINE | ID: mdl-28716153

RESUMO

BACKGROUND: Tranexamic acid prevents blood clots from breaking down and reduces bleeding. However, it is uncertain whether tranexamic acid is effective in traumatic brain injury. The CRASH-3 trial is a randomised controlled trial that will examine the effect of tranexamic acid (versus placebo) on death and disability in 13,000 patients with traumatic brain injury. The CRASH-3 trial hypothesizes that tranexamic acid will reduce intracranial haemorrhage, which will reduce the risk of death. Although it is possible that tranexamic acid will reduce intracranial bleeding, there is also a potential for harm. In particular, tranexamic acid may increase the risk of cerebral thrombosis and ischaemia. The protocol detailed here is for a mechanistic sub-study nested within the CRASH-3 trial. This mechanistic sub-study aims to examine the effect of tranexamic acid (versus placebo) on intracranial bleeding and cerebral ischaemia. METHODS: The CRASH-3 Intracranial Bleeding Mechanistic Sub-Study (CRASH-3 IBMS) is nested within a prospective, double-blind, multi-centre, parallel-arm randomised trial called the CRASH-3 trial. The CRASH-3 IBMS will be conducted in a cohort of approximately 1000 isolated traumatic brain injury patients enrolled in the CRASH-3 trial. In the CRASH-3 IBMS, brain scans acquired before and after randomisation are examined, using validated methods, for evidence of intracranial bleeding and cerebral ischaemia. The primary outcome is the total volume of intracranial bleeding measured on computed tomography after randomisation, adjusting for baseline bleeding volume. Secondary outcomes include progression of intracranial haemorrhage (from pre- to post-randomisation scans), new intracranial haemorrhage (seen on post- but not pre-randomisation scans), intracranial haemorrhage following neurosurgery, and new focal ischaemic lesions (seen on post-but not pre-randomisation scans). A linear regression model will examine whether receipt of the trial treatment can predict haemorrhage volume. Bleeding volumes and new ischaemic lesions will be compared across treatment groups using relative risks and 95% confidence intervals. DISCUSSION: The CRASH-3 IBMS will provide an insight into the mechanism of action of tranexamic acid in traumatic brain injury, as well as information about the risks and benefits. Evidence from this trial could inform the management of patients with traumatic brain injury. TRIAL REGISTRATION: The CRASH-3 trial was prospectively registered and the CRASH-3 IBMS is an addition to the original protocol registered at the International Standard Randomised Controlled Trials registry ( ISRCTN15088122 ) 19 July 2011, and ClinicalTrials.gov on 25 July 2011 (NCT01402882).


Assuntos
Antifibrinolíticos/uso terapêutico , Lesões Encefálicas Traumáticas/tratamento farmacológico , Isquemia Encefálica/tratamento farmacológico , Hemorragia Intracraniana Traumática/tratamento farmacológico , Ácido Tranexâmico/uso terapêutico , Antifibrinolíticos/efeitos adversos , Lesões Encefálicas Traumáticas/diagnóstico por imagem , Lesões Encefálicas Traumáticas/mortalidade , Isquemia Encefálica/diagnóstico por imagem , Isquemia Encefálica/mortalidade , Protocolos Clínicos , Método Duplo-Cego , Escala de Coma de Glasgow , Humanos , Hemorragia Intracraniana Traumática/diagnóstico por imagem , Hemorragia Intracraniana Traumática/mortalidade , Modelos Lineares , Estudos Prospectivos , Projetos de Pesquisa , Fatores de Risco , Fatores de Tempo , Tomografia Computadorizada por Raios X , Ácido Tranexâmico/efeitos adversos , Resultado do Tratamento , Reino Unido
20.
Neurocrit Care ; 27(3): 334-340, 2017 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-28660341

RESUMO

BACKGROUND: Prothrombin complex concentrates (PCCs) have become the first-line therapy for warfarin reversal in the setting of central nervous system (CNS) hemorrhage. Randomized, controlled studies comparing agents for warfarin reversal excluded patients with international normalized ratio (INR) <2, yet INR values of 1.6-1.9 are also associated with poor outcomes. METHODS: We retrospectively reviewed our use of a low-dose (15 units/kg) strategy of 4-factor PCC (4F-PCC) on warfarin reversal (INR 1.6-1.9) in the setting of both traumatic and spontaneous intracranial bleeding. RESULTS: A total of 21/134 (15.7%) patients with either spontaneous or traumatic intracranial hemorrhage presented with an INR value of 1.6-1.9. Nine patients (43%) presented with traumatic bleeding and 12 (57%) with spontaneous bleeding. The median (IQR) presenting INR was 1.8 (1.7, 1.9) which decreased to 1.3 (1.2, 1.3) following the administration of low-dose 4F-PCC (median dose = 1062 units; 15.2 units/kg). A total of 19/20 (95%) patients achieved a goal INR value of ≤1.5 on the first check following dosing and 17/20 (85%) achieved an INR value ≤1.3. One patient did not have follow-up INR testing due to withdrawal of life support. No patient experienced hematoma expansion within 48 h of 4F-PCC, and there were no thromboembolic events within 72 h of administration. CONCLUSIONS: The administration of low dose (15 units/kg) of 4F-PCC for urgent warfarin reversal in the setting of CNS hemorrhage was effective in correcting the INR in patients presenting with INR values of 1.6-1.9. Further assessment of low-dose PCC for urgent reversal of modest INR elevation is warranted.


Assuntos
Anticoagulantes/efeitos adversos , Fatores de Coagulação Sanguínea/farmacologia , Hemorragia Intracraniana Traumática/tratamento farmacológico , Hemorragias Intracranianas/tratamento farmacológico , Avaliação de Resultados em Cuidados de Saúde , Varfarina/efeitos adversos , Idoso , Idoso de 80 Anos ou mais , Fatores de Coagulação Sanguínea/administração & dosagem , Feminino , Humanos , Coeficiente Internacional Normatizado , Hemorragias Intracranianas/induzido quimicamente , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos
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