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1.
Clin Orthop Surg ; 15(6): 942-952, 2023 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-38045586

RESUMEN

Background: This study aimed to evaluate the annual trends of transfusion rates and utilization of blood management agents in total knee arthroplasty (TKA) based on the operation type and to analyze the risk factors of transfusion after TKA. Methods: Using the Korean National Insurance claims database of 797,106 primary and revision TKAs between January 2008 and October 2019, data on the patients' characteristics, comorbidities, utilization of transfusion, and blood management agents were collected. The patients were categorized into three groups based on the operation type: primary, revision, and simultaneous bilateral TKA. The transfusion rate and utilization of blood management agents (intraoperative tranexamic acid [TXA] and preoperative iron supplements) were compared, and the risk factors for transfusion were evaluated. Results: After excluding the inaccurate data, 730,554 arthroplasties (636,292 primary, 10,540 revision, and 41,861 simultaneous bilateral TKAs) were identified. The transfusion rates of primary, revision, and simultaneous bilateral TKAs in 2019 were 64.0%, 67.7%, and 68.9%, respectively, which were significantly decreased compared with 83.2%, 88.0%, and 92.5% in 2008, respectively (p < 0.001). Conversely, the utilization of intraoperative TXA and preoperative iron supplements was significantly increased from 4.6% and 13.8%, respectively, in 2008 to 52.4% and 27.0%, respectively, in 2019 (p < 0.001). The utilization of intraoperative TXA and preoperative iron supplements significantly lowered the risk of transfusion after TKA (odds ratio [OR], 0.20; p < 0.001 and OR, 0.71; p < 0.001). Conclusions: The transfusion rate after TKA decreased gradually from 83.5% to 64.5% between 2008 and 2019 in South Korea corresponding with the increased utilization of blood management agents. Therefore, consistent attention to patient blood management should be emphasized to reduce the transfusion rate after TKA.


Asunto(s)
Antifibrinolíticos , Artroplastia de Reemplazo de Rodilla , Ácido Tranexámico , Humanos , Artroplastia de Reemplazo de Rodilla/efectos adversos , Antifibrinolíticos/uso terapéutico , Ácido Tranexámico/uso terapéutico , Transfusión Sanguínea , Pérdida de Sangre Quirúrgica , Hierro
3.
J Craniofac Surg ; 34(5): 1452-1455, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-37277900

RESUMEN

Tranexamic acid (TXA) has been increasingly utilized in orthognathic surgery, aesthetic surgery, and craniofacial surgery. However, the risk of increasing venous thromboembolic events (VTE) must be carefully considered as TXA is a prothrombotic agent. Our study aimed to investigate the safety of TXA in the setting of facial feminization surgery. These patients are at an elevated risk for VTE at baseline given their uniform history of exogenous estrogen supplementation. A retrospective review of all patients that underwent facial feminization surgery at our medical center between December 2015 and September of 2022 was performed. Demographic information, procedure type, Caprini scores, hematoma rate, VTE rate, estimated blood loss, and operative time were all studied. Unpaired t tests were used to compare patients that received TXA and those who did not. In total, there were 79 surgeries performed during our study period. There were 33 surgeries (41.77%) that used TXA intraoperatively. Ten patients (12.65%) received anticoagulation postoperatively, 5 of whom received TXA intraoperatively. Of the 33 patients who received TXA, 30 patients remained on estrogen therapy. There was no statistically significant difference in VTE rates in patients who received TXA (n=33, 41.77%) and those who did not (n=46, 58.23%). Bleeding events, Caprini scores, estimated blood loss, and operative time were also not found to be significantly different between the 2 cohorts. The authors found no significant increase in VTE in facial feminization patients undergoing estrogen supplementation when intraoperative TXA was utilized. This is the first known report investigating the safety of TXA in this higher risk patient population.


Asunto(s)
Antifibrinolíticos , Ácido Tranexámico , Tromboembolia Venosa , Masculino , Humanos , Ácido Tranexámico/uso terapéutico , Antifibrinolíticos/uso terapéutico , Tromboembolia Venosa/inducido químicamente , Tromboembolia Venosa/epidemiología , Feminización , Estética Dental , Estrógenos/uso terapéutico , Suplementos Dietéticos , Estudios Retrospectivos , Pérdida de Sangre Quirúrgica/prevención & control
4.
Cochrane Database Syst Rev ; 3: CD005431, 2023 03 13.
Artículo en Inglés | MEDLINE | ID: mdl-36912744

RESUMEN

BACKGROUND: Traumatic hyphema is the entry of blood into the anterior chamber, the space between the cornea and iris, following significant injury to the eye. Hyphema may be associated with significant complications that uncommonly cause permanent vision loss. Complications include elevated intraocular pressure, corneal blood staining, anterior and posterior synechiae, and optic nerve atrophy. People with sickle cell trait or disease may be particularly susceptible to increases in intraocular pressure and optic atrophy. Rebleeding is associated with an increase in the rate and severity of complications. OBJECTIVES: To assess the effectiveness of various medical interventions in the management of traumatic hyphema. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2022, Issue 3); MEDLINE Ovid; Embase.com; PubMed (1948 to March 2022); the ISRCTN registry; ClinicalTrials.gov; and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). The last date of the search was 22 March 2022. SELECTION CRITERIA: Two review authors independently assessed the titles and abstracts of all reports identified by the electronic and manual searches. We included randomized and quasi-randomized trials that compared various medical (non-surgical) interventions versus other medical interventions or control groups for the treatment of traumatic hyphema following closed-globe trauma. We applied no restrictions on age, gender, severity of the closed-globe trauma, or level of visual acuity at time of enrollment. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane and assessed the certainty of evidence using GRADE. MAIN RESULTS: We included 23 randomized and seven quasi-randomized studies with a total of 2969 participants. Interventions included antifibrinolytic agents (systemic and topical aminocaproic acid, tranexamic acid, and aminomethylbenzoic acid), corticosteroids (systemic and topical), cycloplegics, miotics, aspirin, conjugated estrogens, traditional Chinese medicine, monocular versus bilateral patching, elevation of the head, and bed rest. We found no evidence of an effect on visual acuity for any intervention, whether measured within two weeks (short term) or for longer periods. In a meta-analysis of two trials, we found no evidence of an effect of aminocaproic acid on long-term visual acuity (RR 1.03, 95% confidence interval (CI) 0.82 to 1.29) or final visual acuity measured up to three years after the hyphema (RR 1.05, 95% CI 0.93 to 1.18). Oral tranexamic acid appeared to provide little to no benefit on visual acuity in four trials (RR 1.12, 95% CI 1.00 to 1.25). The remaining trials evaluated the effects of various interventions on short-term visual acuity; none of these interventions was measured in more than one trial. No intervention showed a statistically significant effect (RRs ranged from 0.75 to 1.10). Similarly, visual acuity measured for longer periods in four trials evaluating different interventions was also not statistically significant (RRs ranged from 0.82 to 1.02). The evidence supporting these findings was of low or very low certainty. Systemic aminocaproic acid reduced the rate of recurrent hemorrhage (RR 0.28, 95% CI 0.13 to 0.60), as assessed in six trials with 330 participants. A sensitivity analysis omitting two studies not using an intention-to-treat analysis reduced the strength of the evidence (RR 0.43, 95% CI 0.17 to 1.08). We obtained similar results for topical aminocaproic acid (RR 0.48, 95% CI 0.20 to 1.10) in two trials with 131 participants. We assessed the certainty of the evidence as low. Systemic tranexamic acid had a significant effect in reducing the rate of secondary hemorrhage (RR 0.33, 95% CI 0.21 to 0.53) in seven trials with 754 participants, as did aminomethylbenzoic acid (RR 0.10, 95% CI 0.02 to 0.41), as reported in one study. Evidence to support an associated reduction in risk of complications from secondary hemorrhage (i.e. corneal blood staining, peripheral anterior synechiae, elevated intraocular pressure, and development of optic atrophy) by antifibrinolytics was limited by the small number of these events. Use of aminocaproic acid was associated with increased nausea, vomiting, and other adverse events compared with placebo. We found no evidence of an effect on the number of adverse events with the use of systemic versus topical aminocaproic acid or with standard versus lower drug dose.  The number of days for the primary hyphema to resolve appeared to be longer with the use of systemic aminocaproic acid compared with no use, but this outcome was not altered by any other intervention. The available evidence on usage of systemic or topical corticosteroids, cycloplegics, or aspirin in traumatic hyphema was limited due to the small numbers of participants and events in the trials. We found no evidence of an effect between a single versus binocular patch on the risk of secondary hemorrhage or time to rebleed. We also found no evidence of an effect on the risk of secondary hemorrhage between ambulation and complete bed rest. AUTHORS' CONCLUSIONS: We found no evidence of an effect on visual acuity of any of the interventions evaluated in this review. Although the evidence was limited, people with traumatic hyphema who receive aminocaproic acid or tranexamic acid are less likely to experience secondary hemorrhage. However, hyphema took longer to clear in people treated with systemic aminocaproic acid. There is no good evidence to support the use of antifibrinolytic agents in the management of traumatic hyphema, other than possibly to reduce the rate of secondary hemorrhage. The potentially long-term deleterious effects of secondary hemorrhage are unknown. Similarly, there is no evidence to support the use of corticosteroids, cycloplegics, or non-drug interventions (such as patching, bed rest, or head elevation) in the management of traumatic hyphema. As these multiple interventions are rarely used in isolation, further research to assess the additive effect of these interventions might be of value.


Asunto(s)
Antifibrinolíticos , Glaucoma , Ácido Tranexámico , Humanos , Corticoesteroides/uso terapéutico , Ácido Aminocaproico/uso terapéutico , Antifibrinolíticos/uso terapéutico , Aspirina/uso terapéutico , Glaucoma/tratamiento farmacológico , Hipema/terapia , Hipema/tratamiento farmacológico , Midriáticos/uso terapéutico , Ácido Tranexámico/uso terapéutico
5.
Altern Ther Health Med ; 29(1): 111-117, 2023 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-35951070

RESUMEN

Context: Knee arthritis is the primary cause of disability in middle-aged and older adults. Total knee arthroplasty (TKA) is also a common treatment in clinics and has a remarkable effect on improving knee-joint function. However, TKA is an invasive procedure that includes a large amount of trauma. It can easily lead to an increase in perioperative blood loss coupled with a long operation time, which can increase the risk of postoperative complications, and also has a long recovery time. Objective: The study intended to analyze the value of tranexamic acid (TXA) plus progressive nursing in accelerating the postoperative rehabilitation of patients undergoing total knee arthroplasty (TKA). Design: The research team designed a prospective non-randomized controlled trial. Setting: The study took place at Cangzhou Hospital of Integrated Traditional Chinese Medicine (TCM) - Western Medicine (WM) Hebei in Cangzhou, Hebei, China. Participants: Participants were 115 patients with knee arthritis who underwent TKA at the hospital between February 2019 and October 2021. Intervention: Of the 115 participants, 55 were assigned to the control group and received conventional nursing care, and 60 were assigned to the intervention group and after surgery received TXA plus progressive nursing. Outcome Measures: The study measured blood loss postoperatively and identified any complications that participants experienced during treatment. At baseline and postintervention, the study also measured knee-joint range of motion (ROM), and the participants completed the Hospital for Special Surgery (HSS) knee survey, the Barthel Index for Activities of Daily Living (ADL), the Self-Rating Depression (SDS) and Self-Rating Anxiety (SAS) scales, a nursing-satisfaction survey, and the World Health Organization Quality of Life Bref (WHO-QOL-BREF) survey. Results: Postoperatively, the blood loss in the intervention group was significantly lower than that in control group, and the knee joint ROM was significantly better in the intervention group (P < .05). In addition, the postoperative Hospital for Special Surgery (HSS) and Barthel scores in the intervention group were significantly higher, and the Self-Rating Anxiety Scale (SAS) and Self-Rating Depression Scale (SDS) scores were significantly lower in the intervention group compared with control group (P < .05). Moreover, a lower incidence of complications and better quality of life were determined for the intervention group (P < .05). Conclusions: Compared with conventional nursing, TXA plus progressive nursing can more effectively promote postoperative recovery of TKA patients; but the exact role of TXA and progressive nursing in TKA deserves further exploration.


Asunto(s)
Antifibrinolíticos , Artritis , Artroplastia de Reemplazo de Rodilla , Ácido Tranexámico , Persona de Mediana Edad , Humanos , Anciano , Ácido Tranexámico/uso terapéutico , Artroplastia de Reemplazo de Rodilla/métodos , Calidad de Vida , Antifibrinolíticos/uso terapéutico , Pérdida de Sangre Quirúrgica , Actividades Cotidianas , Estudios Prospectivos
6.
J Shoulder Elbow Surg ; 32(3): 581-588, 2023 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-36208673

RESUMEN

BACKGROUND: The use of tranexamic acid (TXA) is associated with less blood loss and reduced transfusion risk after shoulder arthroplasty surgery. Recent studies have shown lower odds of postoperative infection after hip or knee arthroplasty with its use. The purpose of this study was to determine whether TXA use reduces the risk of infection after primary elective shoulder arthroplasty. METHODS: A retrospective cohort study was conducted using data from a US integrated health care system's shoulder arthroplasty registry. Patients aged 18 years who underwent primary elective anatomic total shoulder arthroplasty for osteoarthritis or primary reverse shoulder arthroplasty for rotator cuff arthropathy were included (2013-2020). We compared patients who received preoperative intravenous TXA to those who did not receive TXA by assessing the risk for revision due to deep infection within 5 years' follow-up using multivariable Cox proportional hazard regression. Interaction between TXA and diabetes status was analyzed separately. RESULTS: The study sample included 9276 shoulder arthroplasties performed by 153 surgeons at 43 hospitals. The mean age was 70.0 years and 48% were male. The 5-year probability of revision for deep infection was 0.8% and 0.7% for patients with and without TXA, respectively. We failed to observe a difference in infection risk after adjustment for confounders and surgeon differences (hazard ratio [HR] 1.00, 95% confidence interval [CI] 0.56-1.80, P = .998). Further, no differences were observed in patients with (HR 1.64, 95% CI 0.42-6.44, P = .481) or without diabetes (HR 0.79, 95% CI 0.40-1.55, P = .488). CONCLUSION: In a multicenter cohort of more than 9000 primary shoulder arthroplasty procedures, the use of preoperative TXA was not associated with a decrease in the 5-year probability of revision for deep infection.


Asunto(s)
Antifibrinolíticos , Artroplastía de Reemplazo de Hombro , Infecciones , Ácido Tranexámico , Humanos , Masculino , Anciano , Femenino , Ácido Tranexámico/uso terapéutico , Antifibrinolíticos/uso terapéutico , Artroplastía de Reemplazo de Hombro/efectos adversos , Artroplastía de Reemplazo de Hombro/métodos , Estudios de Cohortes , Estudios Retrospectivos , Pérdida de Sangre Quirúrgica
7.
Medicine (Baltimore) ; 100(23): e26221, 2021 Jun 11.
Artículo en Inglés | MEDLINE | ID: mdl-34115006

RESUMEN

BACKGROUND: Vitamin K has long been regarded as a procoagulant drug by physicians, and concerns have been raised with regard to its effects on hemostasis. Although many studies have shown that vitamin K supplementation is safe for thrombotic events, the effect of vitamin K supplementation on the activities of vitamin K dependent procoagulation factors in healthy individuals is not available. OBJECTIVES: This study aimed to investigate whether vitamin K2 supplementation at recommended doses affects the activity of vitamin K dependent procoagulation factors in healthy individuals without any anticoagulation treatment. DESIGN: Forty healthy volunteers between 25 and 40 years of age were recruited. Menaquinone-7 (MK-7) was administrated at 90 µg for 30 days. Prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT), and blood coagulation factors II, VII, IX, and X activities and Protein induced by vitamin K absence or antagonist-II (PIVKA-II) were measured on days 0 and 30 after MK-7 administration. RESULTS: PT, APTT, and TT showed no significant differences on day 30 when compared with baseline. The activities of coagulation factors II, VII, IX, and X on day 30 showed no significant differences with those at baseline. PIVKA-II levels were unchanged after 30 days of MK-7 supplementation. CONCLUSIONS: MK-7 supplementation at recommended dosage does not affect vitamin K-dependent coagulation factors' coagulation activity, and does not enhance the carboxylation of prothrombin in healthy individuals. This indicated that MK-7 administration does not alter hemostatic balance in healthy populations without anticoagulation treatment.


Asunto(s)
Factores de Coagulación Sanguínea/efectos de los fármacos , Suplementos Dietéticos/normas , Vitamina K 2/farmacología , Adulto , Antifibrinolíticos/farmacología , Antifibrinolíticos/uso terapéutico , Factores de Coagulación Sanguínea/análisis , Suplementos Dietéticos/estadística & datos numéricos , Factor IX/análisis , Factor IX/efectos de los fármacos , Factor VII/análisis , Factor VII/efectos de los fármacos , Factor X/análisis , Factor X/efectos de los fármacos , Femenino , Voluntarios Sanos/estadística & datos numéricos , Humanos , Masculino , Tiempo de Tromboplastina Parcial/métodos , Tiempo de Tromboplastina Parcial/estadística & datos numéricos , Protrombina/análisis , Protrombina/efectos de los fármacos , Tiempo de Protrombina/métodos , Tiempo de Protrombina/estadística & datos numéricos , Tiempo de Trombina/métodos , Tiempo de Trombina/estadística & datos numéricos , Vitamina K 2/uso terapéutico
8.
J Am Soc Nephrol ; 32(6): 1474-1483, 2021 06 01.
Artículo en Inglés | MEDLINE | ID: mdl-33753537

RESUMEN

BACKGROUND: In patients with normal renal function or early stage CKD, the risk-benefit profile of direct oral anticoagulants (DOACs) is superior to that of vitamin K antagonists (VKAs). In patients on hemodialysis, the comparative efficacy and safety of DOACs versus VKAs are unknown. METHODS: In the Valkyrie study, 132 patients on hemodialysis with atrial fibrillation were randomized to a VKA with a target INR of 2-3, 10 mg rivaroxaban daily, or rivaroxaban and vitamin K2 for 18 months. Patients continued the originally assigned treatment and follow-up was extended for at least an additional 18 months. The primary efficacy end point was a composite of fatal and nonfatal cardiovascular events. Secondary efficacy end points were individual components of the composite outcome and all-cause death. Safety end points were life-threatening, major, and minor bleeding. RESULTS: Median (IQR) follow-up was 1.88 (1.01-3.38) years. Premature, permanent discontinuation of anticoagulation occurred in 25% of patients. The primary end point occurred at a rate of 63.8 per 100 person-years in the VKA group, 26.2 per 100 person-years in the rivaroxaban group, and 21.4 per 100 person-years in the rivaroxaban and vitamin K2 group. The estimated competing risk-adjusted hazard ratio for the primary end point was 0.41 (95% CI, 0.25 to 0.68; P=0.0006) in the rivaroxaban group and 0.34 (95% CI, 0.19 to 0.61; P=0.0003) in the rivaroxaban and vitamin K2 group, compared with the VKA group. Death from any cause, cardiac death, and risk of stroke were not different between the treatment arms, but symptomatic limb ischemia occurred significantly less frequently with rivaroxaban than with VKA. After adjustment for competing risk of death, the hazard ratio for life-threatening and major bleeding compared with the VKA group was 0.39 (95% CI, 0.17 to 0.90; P=0.03) in the rivaroxaban group, 0.48 (95% CI, 0.22 to 1.08; P=0.08) in the rivaroxaban and vitamin K2 group and 0.44 (95% CI, 0.23 to 0.85; P=0.02) in the pooled rivaroxaban groups. CONCLUSIONS: In patients on hemodialysis with atrial fibrillation, a reduced dose of rivaroxaban significantly decreased the composite outcome of fatal and nonfatal cardiovascular events and major bleeding complications compared with VKA. CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER: Oral Anticoagulation in Hemodialysis, NCT03799822.


Asunto(s)
Antifibrinolíticos/uso terapéutico , Fibrilación Atrial/tratamiento farmacológico , Inhibidores del Factor Xa/uso terapéutico , Hemorragia/inducido químicamente , Diálisis Renal , Rivaroxabán/uso terapéutico , Vitamina K 2/análogos & derivados , Anciano , Anciano de 80 o más Años , Antifibrinolíticos/efectos adversos , Fibrilación Atrial/complicaciones , Enfermedades Cardiovasculares/etiología , Inhibidores del Factor Xa/administración & dosificación , Inhibidores del Factor Xa/efectos adversos , Femenino , Humanos , Relación Normalizada Internacional , Masculino , Mortalidad , Insuficiencia Renal Crónica/complicaciones , Insuficiencia Renal Crónica/fisiopatología , Insuficiencia Renal Crónica/terapia , Rivaroxabán/administración & dosificación , Rivaroxabán/efectos adversos , Vitamina K/antagonistas & inhibidores , Vitamina K 2/efectos adversos , Vitamina K 2/uso terapéutico
9.
Orthop Traumatol Surg Res ; 107(3): 102794, 2021 05.
Artículo en Inglés | MEDLINE | ID: mdl-33333277

RESUMEN

BACKGROUND: Self-transfusion has been proven as an effective management of blood loss after total knee arthroplasty (TKA). Considering that the high local concentration of antibiotic from bone cement is delivered intravenously through the self-transfusion process, systematic toxicity has never been evaluated. In addition, the effectiveness of self-transfusion with the routine concomitant use of other modern blood-salvage strategies, like tranexamic acid, should also be assessed. Therefore, we performed a randomised study to assess: 1) the safety of self-transfusion in TKA by comparing the gentamicin concentrations resulting from the use or not of autologous blood transfusion; 2) the efficacy of self-transfusion in TKA, with the concomitant administration of tranexamic acid. HYPOTHESIS: Self-transfusion in TKA elevates the serum gentamicin concentration and the potential risk of nephrotoxicity. METHODS: The serum concentration of aminoglycosides was measured in two groups of 20 patients each, after TKA, according to the use of self-transfusion. Hemoglobin, renal function and calculated blood loss were compared at several points in time between groups. RESULTS: The only time where there was a statistically significant difference in serum gentamicin, was at 48h postoperatively between groups [0.3 ug/mL±0.21, range: 0.15 to 0.72 vs. 0.14ug/mL±0.1, range: 0 to 0.35 (p=0.02)]. There were no significant differences in total blood loss [1341mL±501, range: 830 to 2230 vs. 1263mL±459 range: 840 to 2480 (p=0.67)] and need of allogeneic blood transfusion [3 units vs. 2 units] between groups. CONCLUSION: The use of autologous blood transfusion was found to be safe, in terms of nephrotoxicity of aminoglycosides after TKA, but it seemed to be ineffective as a blood salvage strategy, when used concomitantly with the administration of tranexamic acid. LEVEL OF EVIDENCE: II; low-powered randomised study. CLINICALTRIALS. GOV REGISTRATION NUMBER: NCT04505748.


Asunto(s)
Antifibrinolíticos , Artroplastia de Reemplazo de Rodilla , Ácido Tranexámico , Antifibrinolíticos/uso terapéutico , Artroplastia de Reemplazo de Rodilla/efectos adversos , Pérdida de Sangre Quirúrgica , Transfusión Sanguínea , Transfusión de Sangre Autóloga , Gentamicinas , Humanos , Hemorragia Posoperatoria , Ácido Tranexámico/uso terapéutico
10.
J Am Geriatr Soc ; 68(9): 2021-2026, 2020 09.
Artículo en Inglés | MEDLINE | ID: mdl-32441334

RESUMEN

BACKGROUND/OBJECTVES: Four direct-acting oral anticoagulants (DOACs) are currently approved by the Food and Drug Administration for the treatment of venous thromboembolism (VTE). Limited efficacy and safety data are available for their use in older adults (aged ≥75 years). METHODS: Medline, Cochrane Central Register of Controlled Trials, Embase, EBSCO, Web of Science, and CINAHL databases were searched for trials comparing DOACs with vitamin K antagonists (VKAs) for the treatment of VTE in older adults from inception through January 1, 2020. Meta-analysis was performed to assess the combined endpoint of recurrent VTE and related deaths and bleeding events (composite of major and clinically relevant nonmajor bleeding). The Mantel-Haenszel relative risk (RR) random effects model was used to pool results across studies. RESULTS: Six randomized controlled trials at low risk of bias met criteria for inclusion with a total of 3,665 patients aged 75 years and older with follow-up of 24 weeks or longer. Data for bleeding events were not available for dabigatran. Overall, DOACs had an improved efficacy over VKAs (RR = .56; 95% confidence interval [CI] = .38-.82). There was no statistically significant difference in the safety outcomes (RR = .77; 95% CI = .56-1.05). No significant heterogeneity was observed for efficacy outcome, and only moderate heterogeneity was observed for safety outcome. CONCLUSION: In older adults with VTE, DOACs appear to improve rates of recurrent VTE and VTE-related deaths compared with VKAs with similar bleeding outcomes.


Asunto(s)
Anticoagulantes/uso terapéutico , Antitrombinas/uso terapéutico , Dabigatrán/uso terapéutico , Tromboembolia Venosa/tratamiento farmacológico , Vitamina K/antagonistas & inhibidores , Administración Oral , Anciano , Antifibrinolíticos/uso terapéutico , Inhibidores del Factor Xa/uso terapéutico , Hemorragia , Humanos , Ensayos Clínicos Controlados Aleatorios como Asunto , Rivaroxabán/uso terapéutico , Tromboembolia Venosa/mortalidad
11.
J Pak Med Assoc ; 70(4): 731-733, 2020 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-32296224

RESUMEN

Mounier-Kuhn Syndrome (MKS) is a rare disorder derived from the muscular and elastic tissue defects of the trachea and the main bronchial walls, characterized by tracheobronchomegaly. Patients may present with complaints of cough, phlegm, dyspnoea and haemoptysis. Haemoptysis may be minor and mixed with phlegm or it may be massive. Establishment of airway patency is a priority in the management of massive haemoptysis. Cold saline solution, diluted adrenaline or tranexamic acid may be administered via the endobronchial route to stop haemorrhage while establishing the airway patency. Ankaferd Blood Stopper (ABS) has a haemostatic property and can be locally administered to the airway. In this report, we aim to highlight the effects of ABS administered via an endobronchial route for emergency palliation of a patient with MKS presenting with massive haemoptysis.


Asunto(s)
Broncoscopía , Hemoptisis/terapia , Hemostasis Endoscópica , Hemostáticos/uso terapéutico , Extractos Vegetales/uso terapéutico , Traqueobroncomegalia/diagnóstico por imagen , Adulto , Antifibrinolíticos/uso terapéutico , Crioterapia , Epinefrina/uso terapéutico , Hemoptisis/etiología , Humanos , Masculino , Tomografía Computarizada por Rayos X , Traqueobroncomegalia/complicaciones , Ácido Tranexámico/uso terapéutico , Insuficiencia del Tratamiento , Resultado del Tratamiento , Vasoconstrictores/uso terapéutico
12.
Eur J Orthop Surg Traumatol ; 30(5): 809-814, 2020 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-32016528

RESUMEN

AIM: In the present retrospective study in scoliosis surgery, we hypothesized that application of a protocol for blood and fluid management, based on goal-directed fluid therapy, cell salvage and tranexamic acid, could lead to reduced allogeneic red blood cells transfusion. METHODS AND MATERIAL: Thirty-five patients, with American Society of Anesthesiologists physical status I/III, between 14 and 18 years scheduled for elective orthopedic surgery of scoliosis, with a planned intensive care unit admission, were enrolled in a retrospective observational study. Patients were divided in two groups. Patients in no-protocol group (Group noPro, n = 18) received a liberal intraoperative fluid therapy and patients in protocol group (Group Pro, n = 17) received fluid therapy managed according to a stroke volume variation-based protocol. The protocol included fluid therapy according to SVV monitor, permissive hypotension, tranexamic acid infusion, restrictive RBC trigger and use of perioperative cell savage. STATISTICAL ANALYSIS USED: Student's t test (2-tailed), Mann-Whitney test, Chi square test were used for statistical analysis of the data. RESULTS: There were no significant differences between the two groups in demographic data and clinical characteristics. Infused crystalloids (p = .003) and transfused allogeneic red blood cells (p = .015) were lesser in Group Pro compared to Group noPro. On the other hand, diuresis (p < .001) and vasopressors administration (p = .042) were higher in Group Pro than in Group noPro. CONCLUSION: The application of a protocol for blood and fluid management, based on goal-directed fluid therapy, cell salvage and tranexamic acid, was associated with less crystalloid fluid administration, less perioperative RBC transfusions and significantly better diuresis than patients in the no-protocol group in scoliosis surgery. REGISTRATION NUMBER: ClinicalTrials.gov Identifier: NCT03814239.


Asunto(s)
Transfusión de Sangre Autóloga , Fluidoterapia/métodos , Escoliosis/cirugía , Adolescente , Antifibrinolíticos/uso terapéutico , Protocolos Clínicos , Soluciones Cristaloides/uso terapéutico , Diuresis , Diuréticos/uso terapéutico , Procedimientos Quirúrgicos Electivos , Transfusión de Eritrocitos , Femenino , Humanos , Cuidados Intraoperatorios , Masculino , Recuperación de Sangre Operatoria , Estudios Retrospectivos , Volumen Sistólico , Ácido Tranexámico/uso terapéutico , Vasoconstrictores/uso terapéutico
13.
Spine (Phila Pa 1976) ; 45(6): E336-E341, 2020 Mar 15.
Artículo en Inglés | MEDLINE | ID: mdl-31574059

RESUMEN

STUDY DESIGN: Observational cohort study with propensity score matching. OBJECTIVE: Determine whether antifibrinolytic drug use is associated with decreased allogeneic blood transfusion in multilevel pediatric spine surgery. SUMMARY OF BACKGROUND DATA: Antifibrinolytic drugs are commonly used in adult multilevel spine surgery to reduce blood loss and allogeneic transfusion; however, only small studies have examined their efficacy in pediatric patients having multilevel spine surgery. METHODS: Pediatric patients who had posterior multilevel spine surgery between 2016 and 2017 were identified in the national surgery quality improvement program participant use file. Propensity score matching was used to reduce bias from confounding and the rate of intraoperative allogeneic transfusion was compared between patients who received antifibrinolytic drugs and those who did not. Secondary outcomes included intraoperative cell saver volume, postoperative allogeneic transfusion, massive intraoperative transfusion, and adverse events including venous thromboembolism and seizure. RESULTS: A total of 6904 patients underwent posterior multilevel spine surgery during the study period and 83% received antifibrinolytics. The matched cohort included 604 patients. Antifibrinolytic use had no association with reduced intraoperative allogeneic transfusion: odds ratio (OR) = 0.71 (99% confidence interval [CI] = 0.40-1.26, P = 0.12) or cell saver volume, median volume = 114 mL (0, 250 mL) in antifibrinolytic group versus 100 mL (0, 246 mL) in control group, P = 0.04. There was also no association with reduced postoperative allogeneic transfusion OR = 1.23 (99% CI = 0.54-2.81, P = 0.52) or massive transfusion OR = 1.0 (99% CI = 0.34-2.92, P = 1.0). No patient in the matched cohort had a venous thromboembolism or seizure. CONCLUSION: Antifibrinolytic drugs are commonly used in pediatric multilevel spine surgery in the United States, but no efficacy was demonstrated in our study. There were no venous thromboembolisms or seizures implying an excellent safety profile in pediatric patients. LEVEL OF EVIDENCE: 3.


Asunto(s)
Antifibrinolíticos/uso terapéutico , Pérdida de Sangre Quirúrgica/prevención & control , Transfusión de Sangre Autóloga/métodos , Puntaje de Propensión , Enfermedades de la Columna Vertebral/cirugía , Fusión Vertebral/efectos adversos , Adolescente , Niño , Estudios de Cohortes , Terapia Combinada/métodos , Femenino , Humanos , Masculino , Procedimientos de Cirugía Plástica/efectos adversos , Procedimientos de Cirugía Plástica/tendencias , Enfermedades de la Columna Vertebral/diagnóstico , Fusión Vertebral/tendencias
14.
J Knee Surg ; 33(1): 34-41, 2020 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-30620987

RESUMEN

Despite the evolution of blood management protocols, total knee arthroplasty (TKA) occasionally requires allogeneic blood transfusion. This poses a particular challenge for Jehovah's Witnesses (JW) who believe that the Bible strictly prohibits the use of blood products. The aim of this study was to compare JW and a matched-control cohort of non-JW candidates undergoing TKA to assess the safety using modern blood management protocols. Fifty-five JW patients (63 knees) who underwent TKA at our institution between 2005 and 2017 were matched to 63 non-JW patients (63 knees). Patient demographics, intraoperative details, and postoperative complications including in-hospital complications, revisions, and 90-day readmissions were collected and compared between the groups. Additionally, subgroup analysis was performed comparing JW patients who were administered tranexamic acid (TXA) between the two groups. Baseline demographics did not vary significantly between the study cohorts. The mean follow-up was 3.1 years in both the JW and non-JW cohorts. Postoperative complications, including in-hospital complications (7.9 vs. 4.8%; p = 0.47), revision TKA (1.6 vs. 1.6%; p = 1.00), and 90-day readmission (1.6 vs. 4.8%; p = 0.31) were not significantly different between the JW and non-JW groups. Subgroup analysis demonstrated JW patients who received TXA had a significantly lower decline in postoperative hemoglobin (Hgb) (8.6 vs. 14.0%; p < 0.01). At a follow-up of up to 12 years, JW patients who underwent TKA have outcomes equivalent to non-JW patients without the need for transfusion. Our findings support that surgeons are more likely to optimize JW patients preoperatively with iron and folate supplementation. Despite these variations in preoperative optimization efforts, no significant difference with regard to Hgb or hematocrit levels was demonstrated. Level of evidence is III, retrospective observational study.


Asunto(s)
Anemia/terapia , Artroplastia de Reemplazo de Rodilla/efectos adversos , Pérdida de Sangre Quirúrgica/prevención & control , Transfusión Sanguínea , Testigos de Jehová , Hemorragia Posoperatoria/terapia , Anciano , Anciano de 80 o más Años , Antifibrinolíticos/uso terapéutico , Artroplastia de Reemplazo de Rodilla/métodos , Epoetina alfa/uso terapéutico , Femenino , Ácido Fólico/uso terapéutico , Hematínicos/uso terapéutico , Hemoglobinas/análisis , Hemostasis Quirúrgica , Humanos , Compuestos de Hierro/uso terapéutico , Masculino , Persona de Mediana Edad , Hemorragia Posoperatoria/etiología , Hemorragia Posoperatoria/prevención & control , Cuidados Preoperatorios , Estudios Retrospectivos , Ácido Tranexámico/uso terapéutico , Resultado del Tratamiento
15.
Medicine (Baltimore) ; 98(18): e15513, 2019 May.
Artículo en Inglés | MEDLINE | ID: mdl-31045842

RESUMEN

INTRODUCTION: Over the last few decades, the concepts of minimally invasive surgery and enhanced recovery after surgery (ERAS) protocols have been introduced into the field of total joint arthroplasty (TJA), and tranexamic acid (TXA) has been widely used in TJA. Modern-day surgical techniques and perioperative care pathways of TJA have experienced unexpected improvements. Recently, the necessity of the practice of ordering routine postoperative laboratory tests for patients undergoing primary TJA has been challenged, especially in the context of implementation of ERAS protocols in TJA. These studies have consistently suggested that routine postoperative laboratory tests are not necessary in modern-day primary, unilateral total hip arthroplasty (THA) or total knee arthroplasty (TKA), and laboratory tests after surgery should only be obtained for patients with risk factors. However, it remains unclear whether routine postoperative laboratory tests after THA and TKA remains justified in the Chinese patient population. Therefore, we developed this study to address this issue. METHODS AND ANALYSIS: This retrospective cohort study will include adult patients who underwent primary unilateral THA or TKA and received multimodal perioperative care pathways according to ERAS protocols. The following patient data will be collected from the electronic medical record system: patients' demographics, preoperative and postoperative laboratory values, operation time, intraoperative blood loss, TXA use, tourniquet use, postoperative length of stay, and any medical intervention directly related to abnormal laboratory values. The main study outcomes are the incidence of acute anemia requiring transfusion and incidence of hypoalbuminemia requiring albumin supplementation. The secondary outcomes are the rates of acute kidney injury, incidence of abnormal serum sodium level, incidence of abnormal serum potassium level, and incidence of abnormal serum calcium level. These clinical data will be analyzed to determine the incidence of abnormal postoperative laboratory values following primary unilateral THA and TKA; to clarify the frequency of any medical intervention directly related to abnormal postoperative laboratory values; and to identify risk factors that predispose patients to have abnormal postoperative laboratory results. STUDY REGISTRATION: Chinese Clinical Trial Registry (http://www.chictr.org.cn): ChiCTR1900020690.


Asunto(s)
Artroplastia de Reemplazo de Cadera/rehabilitación , Artroplastia de Reemplazo de Rodilla/rehabilitación , Técnicas de Laboratorio Clínico/normas , Cuidados Posoperatorios/normas , Complicaciones Posoperatorias/diagnóstico , Adulto , Anemia/diagnóstico , Anemia/epidemiología , Anemia/etiología , Antifibrinolíticos/uso terapéutico , Artroplastia de Reemplazo de Cadera/estadística & datos numéricos , Artroplastia de Reemplazo de Rodilla/estadística & datos numéricos , Técnicas de Laboratorio Clínico/métodos , Protocolos Clínicos/normas , Femenino , Humanos , Hipoalbuminemia/diagnóstico , Hipoalbuminemia/epidemiología , Hipoalbuminemia/etiología , Incidencia , Masculino , Persona de Mediana Edad , Cuidados Posoperatorios/métodos , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Periodo Posoperatorio , Proyectos de Investigación , Estudios Retrospectivos , Factores de Riesgo , Ácido Tranexámico/uso terapéutico
16.
J Thromb Haemost ; 17(9): 1461-1469, 2019 09.
Artículo en Inglés | MEDLINE | ID: mdl-31136076

RESUMEN

BACKGROUND: Excessive, plasmin-mediated fibrinolysis augments bleeding and contributes to death in some patients. Current therapies for fibrinolytic bleeding are limited by modest efficacy, low potency, and off-target effects. OBJECTIVES: To determine whether an antibody directed against unique loop structures of the plasmin protease domain may have enhanced specificity and potency for blocking plasmin activity, fibrinolysis, and experimental hemorrhage. METHODS: The binding specificity, affinity, protease cross-reactivity and antifibrinolytic properties of a monoclonal plasmin inhibitor antibody (Pi) were examined and compared with those of epsilon aminocaproic acid (EACA), which is a clinically used fibrinolysis inhibitor. RESULTS: Pi specifically recognized loop 5 of the protease domain, and did not bind to other serine proteases or nine other non-primate plasminogens. Pi was ~7 logs more potent in neutralizing plasmin cleavage of small-molecule substrates and >3 logs more potent in quenching fibrinolysis than EACA. Pi was similarly effective in blocking catalysis of a small-molecule substrate as α2 -antiplasmin, which is the most potent covalent inhibitor of plasmin, and was a more potent fibrinolysis inhibitor. Fab or chimerized Fab fragments of Pi were equivalently effective. In vivo, in a humanized model of fibrinolytic surgical bleeding, Pi significantly reduced bleeding to a greater extent than a clinical dose of EACA. CONCLUSIONS: A mAb directed against unique loop sequences in the protease domain is a highly specific, potent, competitive plasmin inhibitor that significantly reduces experimental surgical bleeding in vivo.


Asunto(s)
Anticuerpos Monoclonales Humanizados/uso terapéutico , Antifibrinolíticos/uso terapéutico , Fibrinolisina/antagonistas & inhibidores , Hemorragia/tratamiento farmacológico , Ácido Aminocaproico/farmacología , Ácido Aminocaproico/uso terapéutico , Animales , Anticuerpos Monoclonales Humanizados/inmunología , Anticuerpos Monoclonales Humanizados/farmacología , Afinidad de Anticuerpos , Unión Competitiva , Dominio Catalítico/inmunología , Reacciones Cruzadas , Evaluación Preclínica de Medicamentos , Femenino , Fibrinolisina/química , Fibrinolisina/inmunología , Fibrinólisis/efectos de los fármacos , Hemorragia/sangre , Humanos , Ratones , Ratones Endogámicos C57BL , Modelos Moleculares , Conformación Proteica , Dominios Proteicos , Distribución Aleatoria , Proteínas Recombinantes de Fusión/inmunología , Especificidad de la Especie , Especificidad por Sustrato
17.
Lung ; 197(3): 349-352, 2019 06.
Artículo en Inglés | MEDLINE | ID: mdl-31004190

RESUMEN

A large-scale outbreak of life-threatening, inhaled synthetic cannabinoids (Spice/K2)-associated coagulopathy with bleeding complications was recently reported in Illinois. The causative agents were brodifacoum, difenacoum, and bromadiolone, potent, long-acting, 4-hydroxycoumarin anticoagulant rodenticides (LAAR) that were mixed with Spice/K2 products procured and then inhaled by the victims. We report on 3 poisoned patients who reside in underserved, socioeconomically disadvantaged neighborhoods of Chicago that were admitted and treated successfully at two inner-city, tertiary care hospitals in Chicago. The patients were discharged from the hospitals on daily long-term high-dose oral vitamin K1 (VK1), provided free of charge. However, 2 patients were lost to follow-up prior to safe discontinuation of oral VK1 therapy. The third patient was treated and followed successfully for 7 months when VK1 was discontinued. We conclude that prolonged oral VK1 therapy and follow-up of acute, life-threatening LAAR poisoning are variable and present challenges to healthcare providers. Appropriate practice guidelines to improve patient access and adherence to daily high-dose oral VK1 therapy and follow-up should be developed and implemented.


Asunto(s)
Anticoagulantes/envenenamiento , Antifibrinolíticos/administración & dosificación , Trastornos de la Coagulación Sanguínea/tratamiento farmacológico , Cannabinoides , Hemorragia/tratamiento farmacológico , Cooperación del Paciente , Vitamina K 1/administración & dosificación , 4-Hidroxicumarinas/envenenamiento , Administración por Inhalación , Adulto , Cuidados Posteriores , Antifibrinolíticos/uso terapéutico , Trastornos de la Coagulación Sanguínea/inducido químicamente , Chicago , Femenino , Hemorragia/inducido químicamente , Humanos , Relación Normalizada Internacional , Perdida de Seguimiento , Masculino , Cumplimiento de la Medicación , Persona de Mediana Edad , Drogas Sintéticas , Vitamina K 1/uso terapéutico
18.
Dermatol Clin ; 37(2): 175-181, 2019 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-30850040

RESUMEN

Pigmentary disorders are common and can be very distressing to patients. There is a need for better, standardized therapies. The authors review the most recent data for topical, systemic, light, and laser treatments for vitiligo, melasma, and postinflammatory hyperpigmentation. There is a paucity of large-scale, well-designed, randomized, controlled trials for these treatments. Treatment options are often drawn from smaller trials and case series. The treatments described in this article are promising candidates for larger follow-up studies.


Asunto(s)
Fármacos Dermatológicos/uso terapéutico , Inhibidores de las Cinasas Janus/uso terapéutico , Trastornos de la Pigmentación/terapia , Antifibrinolíticos/uso terapéutico , Bimatoprost/uso terapéutico , Humanos , Hidroquinonas/uso terapéutico , Inflamación , Queratinocitos/trasplante , Láseres de Estado Sólido/uso terapéutico , Terapia por Luz de Baja Intensidad , Melanocitos/trasplante , Melanosis , Preparaciones para Aclaramiento de la Piel/uso terapéutico , Protectores Solares/uso terapéutico , Ácido Tranexámico/uso terapéutico , Vitíligo/terapia , alfa-MSH/análogos & derivados , alfa-MSH/uso terapéutico
19.
Orthop Clin North Am ; 50(2): 171-179, 2019 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-30850076

RESUMEN

Active assessment and management of hypovitaminosis D among orthopedic patients is low-risk and low-cost while retaining significant potential to improve patient care. Vitamin D has an established role in musculoskeletal development and calcium homeostasis, and vitamin D deficiency is pervasive in orthopedic trauma populations. Clinical guidelines for screening and supplementation for hypovitaminosis D are lacking. Literature on the effects of vitamin K on bone health is limited. Anabolic hormone analogues may have a future role in delayed union or nonunion treatment. Vitamin D deficiency and other endocrine abnormalities should be considered in orthopedic trauma patients presenting with fracture nonunion of uncertain cause.


Asunto(s)
Fracturas no Consolidadas/etiología , Fracturas no Consolidadas/prevención & control , Sistema Musculoesquelético/efectos de los fármacos , Deficiencia de Vitamina D/epidemiología , Vitamina D/administración & dosificación , Adulto , Anciano , Anabolizantes/efectos adversos , Antifibrinolíticos/uso terapéutico , Conservadores de la Densidad Ósea/uso terapéutico , Calcio/administración & dosificación , Calcio/uso terapéutico , Programas de Detección Diagnóstica/normas , Femenino , Fracturas no Consolidadas/fisiopatología , Homeostasis/fisiología , Humanos , Masculino , Persona de Mediana Edad , Prevalencia , Factores de Riesgo , Resultado del Tratamiento , Vitamina D/uso terapéutico , Deficiencia de Vitamina D/etiología , Deficiencia de Vitamina D/prevención & control , Vitamina K/administración & dosificación , Vitamina K/uso terapéutico
20.
Bone Joint J ; 101-B(2): 207-212, 2019 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-30700116

RESUMEN

AIMS: Cementless primary total hip arthroplasty (THA) is associated with risks of bleeding and thromboembolism. Anticoagulants are effective as venous thromboprophylaxis, but with an increased risk of bleeding. Tranexamic acid (TXA) is an efficient antifibrinolytic agent, but the mode and timing of its administration remain controversial. This study aimed to determine whether two intravenous (IV) TXA regimens (a three-hour two-dose (short-TXA) and 11-hour four-dose (long-TXA)) were more effective than placebo in reducing perioperative real blood loss (RBL, between baseline and day 3 postoperatively) in patients undergoing THA who receive rivaroxaban as thromboprophylaxis. The secondary aim was to assess the non-inferiority of the reduction of blood loss of the short protocol versus the long protocol. PATIENTS AND METHODS: A multicentre, prospective, randomized, double-blind, placebo-controlled trial was undertaken involving 229 patients undergoing primary cementless THA using a posterior approach, whose extended rivaroxaban thromboprophylaxis started on the day of surgery. There were 98 male and 131 female patients, with a mean age of 65.5 years (32 to 91). The primary outcome, perioperative RBL, was evaluated at 72 hours postoperatively. The efficacy of short- and long-TXA protocols in the reduction of perioperative RBL was compared with a placebo group. RESULTS: TXA significantly reduced perioperative blood loss compared with placebo (p < 0.001); the mean differences were 525.3 ml (short-TXA vs placebo) and 550.1 ml (long-TXA vs placebo). No venous or arterial thromboembolic complications were reported. The upper boundary of the 95% confidence interval, when comparing short and long protocols, was below the pre-specified margin of non-inferiority (p = 0.027). CONCLUSION: In patients undergoing primary cementless THA, using a posterior approach, who are treated with rivaroxaban for thromboembolic prophylaxis, short- and long-TXA IV protocols are significantly more effective than placebo in reducing perioperative RBL, without any thromboembolic complications. Non-inferiority of a short- versus a long-TXA protocol in reducing perioperative RBL was supported in a secondary analysis.


Asunto(s)
Artroplastia de Reemplazo de Cadera , Pérdida de Sangre Quirúrgica/prevención & control , Fármacos Hematológicos/uso terapéutico , Artropatías/cirugía , Rivaroxabán/uso terapéutico , Ácido Tranexámico/uso terapéutico , Adulto , Anciano , Anciano de 80 o más Años , Antifibrinolíticos/uso terapéutico , Cementos para Huesos , Cementación , Quimioprevención , Método Doble Ciego , Inhibidores del Factor Xa/uso terapéutico , Femenino , Articulación de la Cadera/cirugía , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Resultado del Tratamiento
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