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2.
BMJ Open ; 11(1): e040273, 2021 01 17.
Artigo em Inglês | MEDLINE | ID: mdl-33455926

RESUMO

INTRODUCTION: Blood transfusion and anaemia are frequent and are associated with poor outcomes in patients with hip fracture (HF). We hypothesised that preoperative intravenous iron and tranexamic acid (TXA) may reduce the transfusion rate in these patients. METHODS AND ANALYSIS: The HiFIT study is a multicentre, 2×2 factorial, randomised, double-blinded, controlled trial evaluating the effect of iron isomaltoside (IIM) (20 mg/kg) vs placebo and of TXA (intravenously at inclusion and topically during surgery) versus placebo on transfusion rate during hospitalisation, in patients undergoing emergency surgery for HF and having a preoperative haemoglobin between 95 and 130 g/L. 780 patients are expected. The primary endpoint is the proportion of patients receiving an allogenic blood transfusion of packed red blood cells from the day of surgery until hospital discharge (or until D30 if patient is still hospitalised). Enrolment started on March 2017 in 11 French hospitals. The study was stopped between July 2017 and August 2018 (because of investigation of serious AEs with IIM in Spain) and slowed down since March 2020 (COVID-19 crisis). The expected date of final follow-up is May 2022. Analyses of the intent-to-treat and per-protocol populations are planned. ETHICS AND DISSEMINATION: The HiFIT trial protocol has been approved by the Ethics Committee of Comité de Protection des Personnes Ouest II and the French authorities (ANSM). It will be carried out according to the principles of the Declaration of Helsinki and the Good Clinical Practice guidelines. The results will be disseminated through presentation at scientific conferences and publication in peer-reviewed journals. The HiFIT trial will be the largest study evaluating iron and TXA in patients with HF. TRIAL REGISTRATION NUMBER: clinicalTrials.gov identifier: NCT02972294; EudraCT Number 2016-003087-40.


Assuntos
Anemia/tratamento farmacológico , Transfusão de Sangue/estatística & dados numéricos , Fraturas do Quadril/cirurgia , Ferro/uso terapêutico , Ácido Tranexâmico/uso terapêutico , Administração Intravenosa , Antifibrinolíticos/uso terapêutico , Perda Sanguínea Cirúrgica/prevenção & controle , Ensaios Clínicos Fase III como Assunto , Método Duplo-Cego , França , Hemoglobinas/análise , Fraturas do Quadril/complicações , Humanos , Estudos Multicêntricos como Assunto , Cuidados Pré-Operatórios/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento
3.
BJOG ; 128(1): 114-120, 2021 01.
Artigo em Inglês | MEDLINE | ID: mdl-32770781

RESUMO

OBJECTIVE: To estimate the cost-effectiveness of tranexamic acid (TXA) use to prevent postpartum haemorrhage. DESIGN: A trial-based economic evaluation. SETTING: Fifteen French university maternity hospitals. POPULATION: Women enrolled in the TRAAP randomised controlled trial comparing TXA versus placebo in women with vaginal delivery. TRAAP failed to show a reduction in postpartum haemorrhage of at least 500 ml in the intervention arm but evidenced significant lower rates of secondary outcomes related to blood loss. METHODS & MAIN OUTCOME MEASURES: We estimated direct medical costs from within-trial hospital resources collected prospectively from the study report form. All resources were costed at their value to the hospital. We estimated incremental cost per incremental haemorrhage averted. RESULTS: Among the 4079 women in the TRAAP trial, data necessary to calculate costs were available for 3836 (94.0%). The average total costs in the TXA and control groups were €2278 ± 388 and €2288 ± 409 per woman, respectively (P = 0.79). In women with postpartum haemorrhage of at least 500 ml (trial primary endpoint), costs were €2359 ± 354 and €2409 ± 525 (P = 0.14); for provider-assessed clinically significant postpartum haemorrhage and postpartum haemorrhage of at least 1000 ml, costs were respectively €2316 ± 347 versus €2381 ± 521 (P = 0.22) and €2321 ± 318 versus €2411 ± 590 (P = 0.35) in the tranexamic and placebo groups, respectively. The probabilistic sensitivity analysis showed that the use of TXA had a 65-73% probability of saving costs and improving outcome. CONCLUSIONS: Our findings support the use of TXA, as both bleeding events and cost may be reduced three out of four times. TWEETABLE ABSTRACT: Tranexamic acid at vaginal delivery reduces both costs and bleeding events 3 times out of 4.


Assuntos
Antifibrinolíticos/uso terapêutico , Parto Obstétrico , Hemorragia Pós-Parto/prevenção & controle , Ácido Tranexâmico/uso terapêutico , Adulto , Antifibrinolíticos/economia , Análise Custo-Benefício , Feminino , França , Hospitais Universitários , Humanos , Gravidez , Cuidado Pré-Natal , Ácido Tranexâmico/economia
4.
Anesthesiology ; 134(2): 165-178, 2021 02 01.
Artigo em Inglês | MEDLINE | ID: mdl-33316069

RESUMO

BACKGROUND: It is unclear whether high-dose regimens of tranexamic acid in cardiac surgery (total dose, 80 to 100 mg/kg) confer a clinical advantage over low-dose regimens (total dose, approximately 20 mg/kg), particularly as tranexamic acid-associated seizure may be dose-related. The authors' aim was to characterize the exposure-response relationship of this drug. METHODS: Databases were searched for randomized controlled trials of intravenous tranexamic acid in adult patients undergoing cardiopulmonary bypass surgery. Observational studies were added for seizure assessment. Tranexamic acid concentrations were predicted in each arm of each study using a population pharmacokinetic model. The exposure-response relationship was evaluated by performing a model-based meta-analysis using nonlinear mixed-effect models. RESULTS: Sixty-four randomized controlled trials and 18 observational studies (49,817 patients) were included. Seventy-three different regimens of tranexamic acid were identified, with the total dose administered ranging from 5.5 mg/kg to 20 g. The maximum effect of tranexamic acid for postoperative blood loss reduction was 40% (95% credible interval, 34 to 47%), and the EC50 was 5.6 mg/l (95% credible interval, 0.7 to 11 mg/l). Exposure values with low-dose regimens approached the 80% effective concentration, whereas with high-dose regimens, they exceeded the 90% effective concentration. The predicted cumulative blood loss up to 48 h postsurgery differed by 58 ml between the two regimens, and the absolute difference in erythrocyte transfusion rate was 2%. Compared to no tranexamic acid, low-dose and high-dose regimens increased the risk of seizure by 1.2-fold and 2-fold, respectively. However, the absolute risk increase was only clinically meaningful in the context of prolonged open-chamber surgery. CONCLUSIONS: In cardiopulmonary bypass surgery, low-dose tranexamic acid seems to be an appropriate regimen for reducing bleeding outcomes. This meta-analysis has to be interpreted with caution because the results are observational and dependent on the lack of bias of the predicted tranexamic acid exposures and the quality of the included studies.


Assuntos
Antifibrinolíticos/uso terapêutico , Perda Sanguínea Cirúrgica/prevenção & controle , Procedimentos Cirúrgicos Cardíacos , Hemorragia Pós-Operatória/tratamento farmacológico , Ácido Tranexâmico/uso terapêutico , Relação Dose-Resposta a Droga , Humanos
5.
J Spec Oper Med ; 20(4): 85-91, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33320318

RESUMO

Early tranexamic acid (TXA) administration for resuscitation of critically injured warfighters provides a mortality benefit. The 2019 Tactical Combat Casualty Care (TCCC) recommendations of a 1g drip over 10 minutes, followed by 1g drip over 8 hours, is intended to limit potential TXA side effects, including hypotension, seizures, and anaphylaxis. However, this slow and cumbersome TXA infusion protocol is difficult to execute in the tactical care environment. Additionally, the side effect cautions derive from studies of elderly or cardiothoracic surgery patients, not young healthy warfighters. Therefore, the 75th Ranger Regiment developed and implemented a 2g intravenous or intraosseous (IV/IO) TXA flush protocol. We report on the first six cases of this protocol in the history of the Regiment. After-action reports (AARs) revealed no incidences of post-TXA hypotension, seizures, or anaphylaxis. Combined, the results of this case series are encouraging and provide a foundation for larger studies to fully determine the safety of the novel 2g IV/IO TXA flush protocol toward preserving the lives of traumatically injured warfighters.


Assuntos
Ácido Tranexâmico/uso terapêutico , Administração Intravenosa , Antifibrinolíticos/uso terapêutico , Humanos , Infusões Intraósseas
6.
Acta Ortop Mex ; 34(1): 6-9, 2020.
Artigo em Espanhol | MEDLINE | ID: mdl-33230992

RESUMO

INTRODUCTION: ATC can cause considerable blood loss. To reduce the need for blood transfusion, various preoperative techniques such as administration of tranexamic acid (ATX) are used. OBJECTIVE: to demonstrate that the use of ATX decreases the need for allogeneic blood transfusion in patients operated on ATC. MATERIAL AND METHODS: Prospective, observational, descriptive study, used to observe the allogeneic blood transfusion rate in patients who underwent unilateral primary ATC from May 2016 to December 2017. ATX was applied preoperatively and after 24 hours a blood count was taken and the need for blood transfusion was assessed. RESULTS: A total of 70 patients were included in the study. The average postoperative Hb 11.7 mg/dl with a range of 9.2 to 14.9 mg/dl and an average Ht of 37.1% with a range of 30.2 to 44.2%. None of the patients required allogeneic blood transfusión. CONCLUSIONS: This study demonstrates how ATX is a transoperative strategy to reduce the need for allogeneic blood transfusion in patients undergoing primary ATC.


Assuntos
Antifibrinolíticos , Artroplastia de Quadril , Ácido Tranexâmico , Antifibrinolíticos/uso terapêutico , Perda Sanguínea Cirúrgica/prevenção & controle , Transfusão de Sangue , Humanos , Estudos Prospectivos , Ácido Tranexâmico/uso terapêutico
7.
Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi ; 34(11): 1468-1473, 2020 Nov 15.
Artigo em Chinês | MEDLINE | ID: mdl-33191708

RESUMO

Objective: To review the advances in the application of tranexamic acid (TXA) in adolescent spinal corrective surgery. Methods: The mechanism of action and pharmacokinetic, effectiveness, dosage, safety as well as methods of administration were comprehensively summarized by consulting domestic and overseas related literature about the application of TXA in adolescent spinal corrective surgery in recent years. Results: TXA efficaciously reduce intraoperative blood loss, transfusion rate and volume, postoperative drainage volume in adolescent spinal corrective surgery. At present, the most common method of administration in adolescent spinal corrective surgery is that a loading dose is given intravenously before skin incision or induction of anesthesia, followed by a maintenance dose until the end of the surgery. The range of loading dose and maintenance dose is 10-100 mg/kg and 1-10 mg/(kg·h), respectively. No drug related adverse event has been reported in this range. Conclusion: The effectiveness and safety of TXA in adolescent spinal surgery have been basically confirmed. However, further studies are needed to determine the optimal dosage, method of administration as well as whether it could reduce blood loss after surgery.


Assuntos
Antifibrinolíticos , Ácido Tranexâmico , Adolescente , Antifibrinolíticos/uso terapêutico , Perda Sanguínea Cirúrgica/prevenção & controle , Transfusão de Sangue , Humanos , Período Pós-Operatório , Ácido Tranexâmico/uso terapêutico
8.
Medicine (Baltimore) ; 99(44): e22999, 2020 Oct 30.
Artigo em Inglês | MEDLINE | ID: mdl-33126380

RESUMO

BACKGROUND: The efficacy and safety of oral tranexamic acid (TXA) remain controversial because of the small number of clinical studies. The aim of the present study was to compare the efficacy and safety of oral TXA with intravenous TXA in patients undergoing total hip arthroplasty and total knee arthroplasty in a systematic review and meta-analysis. METHODS: We conducted a meta-analysis to identify randomized controlled trials (RCTs) involving oral and intravenous TXA in total hip arthroplasty and total knee arthroplasty up to December 2019 by searching databases including PubMed, Web of Science, Embase, the Cochrane Controlled Trials Register, the Cochrane Library China Biology Medicine, China National Knowledge Infrastructure, China Science and Technology Journal Database and Wanfang. The mean difference or standard mean difference was used to assess continuous outcomes such as hemoglobin (Hb) drop, total blood loss, drain blood loss, and length of hospital stay, with a 95% confidence interval. Relative risks with a 95% confidence interval were used to assess dichotomous outcomes such as transfusion rate and the incidence of deep venous thrombosis and calf muscular vein thrombosis. Review Manager was used for the meta-analysis. RESULTS: Ten RCTs containing 1080 participants met the inclusion criteria. We found no significant differences in terms of the average Hb drop (P = .60), total blood loss (P = .60), transfusion rate (P = .99), drain blood loss (P = .91), length of hospital stay (P = .95), and the incidence of deep venous thrombosis (P = .55) and calf muscular vein thrombosis (P = .19) between oral and IV TXA. CONCLUSIONS: Compared with the IV TXA, oral TXA has similar effects on reducing the Hb drop, total blood loss, transfusion rate, drain blood loss, and length of hospital stay without increasing the risk of calf muscular vein thrombosis and deep venous thrombosis. Furthermore, oral TXA is easy to access and administer, which decreases the workload of nurses and even delivers cost-saving benefits to the health care system. We thus conclude that oral TXA may be an optimal approach in total joint arthroplasty. However, more high-quality and multicenter RCTs are still needed to confirm our conclusions. REGISTRATION: The current meta-analysis was registered on PROSPERO (International Prospective Register of Systematic Reviews), and the registration number was CRD42018111291.


Assuntos
Antifibrinolíticos/uso terapêutico , Artroplastia de Quadril , Artroplastia do Joelho , Ácido Tranexâmico/uso terapêutico , Trombose Venosa/prevenção & controle , Administração Oral , Antifibrinolíticos/administração & dosagem , Humanos , Infusões Intravenosas , Complicações Pós-Operatórias/prevenção & controle , Ensaios Clínicos Controlados Aleatórios como Assunto , Ácido Tranexâmico/administração & dosagem
9.
Emerg Med Clin North Am ; 38(4): 795-805, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-32981618

RESUMO

Successful emergency transfusions require early recognition and activation of resources to minimize treatment delays. The initial goals should focus on replacement of blood in a balanced fashion. There is an ongoing debate regarding the best approach to transfusions, with some advocating for resuscitation with a fixed ratio of blood products and others preferring to use viscoelastic assays to guide transfusions. Whole-blood transfusion also is a debated strategy. Despite these different approaches, it generally is accepted that transfusions should be started early and crystalloid infusions limited. As hemodynamic stability is restored, endpoints of resuscitation should be used to guide the resuscitation.


Assuntos
Transfusão de Sangue , Choque Hemorrágico/terapia , Antifibrinolíticos/uso terapêutico , Tipagem e Reações Cruzadas Sanguíneas , Cateterismo Venoso Central , Tomada de Decisão Clínica , Protocolos Clínicos , Estado Terminal , Serviços Médicos de Emergência , Serviço Hospitalar de Emergência , Humanos , Hipotensão , Infusões Intraósseas , Infusões Intravenosas , Ressuscitação , Tromboelastografia , Ácido Tranexâmico/uso terapêutico , Ferimentos e Lesões/terapia
10.
Emerg Med Clin North Am ; 38(4): 871-889, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-32981623

RESUMO

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


Assuntos
Hemorragia Gastrointestinal/terapia , Manuseio das Vias Aéreas , Antibacterianos/uso terapêutico , Anticorpos Monoclonais Humanizados/administração & dosagem , Anticoagulantes/efeitos adversos , Antifibrinolíticos/uso terapêutico , Oclusão com Balão , Fatores de Coagulação Sanguínea/administração & dosagem , Transfusão de Sangue/métodos , Cateteres , Serviço Hospitalar de Emergência , Fator Xa/administração & dosagem , Hemorragia Gastrointestinal/diagnóstico , Hemorragia Gastrointestinal/etiologia , Humanos , Infusões Intraósseas , Infusões Intravenosas , Anamnese , Exame Físico , Inibidores da Bomba de Prótons/uso terapêutico , Proteínas Recombinantes/administração & dosagem , Ressuscitação , Tromboelastografia , Vasoconstritores/uso terapêutico
11.
J Extra Corpor Technol ; 52(3): 182-190, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32981955

RESUMO

Intraoperative cell salvage (ICS) is a critical component of any blood management program involving surgery with a high potential for blood loss. The introduction of antifibrinolytics (AF) may reduce blood loss. The purpose of this study was to evaluate the use of AF on ICS in non-cardiac surgical procedures. Following institutional review board approval, 69,935 consecutive case records between January 2016 and September 2019 from a national registry of adult surgical patients were reviewed. Procedure types were stratified into one of nine surgical categories: general (GN, n = 1,525), neurosurgical (NS, n = 479), obstetric (OB, n = 1,563), cervical spine (CS, n = 2,701), lumbar spine (LS, n = 38,383), hip arthroplasty (HA, n = 13,327), knee arthroplasty (KA, n = 596), vascular (VA, n = 9,845), or orthopedic other (OO, n = 1,516). The primary endpoint was the use of AF with the secondary endpoints ICS shed blood volume and volume available for return. The overall use of AF across all surgical procedures increased from 21.4% in 2016 to 25.4% in 2019. The greatest increases were seen in NS (4.4% to 16.2%), LS (13.7% to 23.1%), and HA (55.8% to 61.9%). For several procedure types, there was an initial increase then either a leveling off or a decline in AF use: OB initially increased from 6.2% to 10.8% in 2018, whereas GN (9.4% to 7.2%) and VA surgery declined slightly (9.9% to 5.7%). When comparing patients who did not receive AF with those who did, there were similar volumes of ICS available for return in all groups, except for LS, GN, and VA, where lower volumes were seen in the No-AF groups. The use of AF has increased each year over the 4-year period in most of the surgical categories, but several have declined. There may be a beneficial effect of AF with lower ICS volumes available for return in a few groups.


Assuntos
Antifibrinolíticos , Adulto , Antifibrinolíticos/uso terapêutico , Perda Sanguínea Cirúrgica/prevenção & controle , Feminino , Humanos , Gravidez , Sistema de Registros
12.
J Spec Oper Med ; 20(3): 36-43, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32969002

RESUMO

The literature continues to provide strong support for the early use of tranexamic acid (TXA) in severely injured trauma patients. Questions persist, however, regarding the optimal medical and tactical/logistical use, timing, and dose of this medication, both from the published TXA literature and from the TCCC user community. The use of TXA has been explored outside of trauma, new dosing strategies have been pursued, and expansion of retrospective use data has grown as well. These questions emphasize the need for a reexamination of TXA by the CoTCCC. The most significant updates to the TCCC Guidelines are (i) including significant traumatic brain injury (TBI) as an indication for TXA, (ii) changing the dosing protocol to a single 2g IV/IO administration, and (iii) recommending TXA administration via slow IV/IO push.


Assuntos
Ácido Tranexâmico/uso terapêutico , Antifibrinolíticos/uso terapêutico , Humanos , Estudos Retrospectivos
13.
Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi ; 34(9): 1158-1162, 2020 Sep 15.
Artigo em Chinês | MEDLINE | ID: mdl-32929910

RESUMO

Objective: To investigate the effect and safety of tranexamic acid sequential rivaroxaban on perioperative blood loss and preventing thrombosis for elderly patients during lumbar interbody fusion (LIF) with a prospective randomized controlled study. Methods: Between April and October 2019, the elderly patients with lumbar degenerative diseases requiring LIF were included in the study, among which were 80 patients met the selection criteria. According to the antifibrinolysis and anticoagulation protocols, they were randomly divided into a tranexamic acid sequential rivaroxaban group (trial group) and a simple rivaroxaban group (control group) on average. Finally, 69 patients (35 in the trial group and 34 in the control group) were included for comparison. There was no significant difference in general data ( P>0.05) such as gender, age, body mass index, disease duration, diseased segment, type of disease, and preoperative hemoglobin between the two groups. The operation time, intraoperative blood loss, drainage within 3 days after operation, perioperative total blood loss, and proportion of blood transfusion patients were compared between the two groups, as well as postoperative venous thrombosis of lower extremities, pulmonary embolism, and bleeding-related complications. Results: The operations of the two groups completed successfully, and there was no significant difference in the operation time ( P>0.05); the intraoperative blood loss, drainage within 3 days after operation, and perioperative total blood loss in the trial group were significantly lower than those in the control group ( P<0.05). The proportion of blood transfusion patients in the trial group was 25.71% (9/35), which was significantly lower than that in the control group [52.94% (18/34)] ( χ 2=5.368, P=0.021). Postoperative incision bleeding occurred in 4 cases of the trial group and 3 cases of the control group, and there was no significant difference in bleeding-related complications between the two groups ( P=1.000). There was 1 case of venous thrombosis of the lower extremities in each group after operation, and there was no significant difference in the incidence between the two groups ( P=1.000). Besides, no pulmonary embolism occurred in the two groups. Conclusion: Perioperative use of tranexamic acid sequential rivaroxaban in elderly LIF patients can effectively reduce the amount of blood loss and the proportion of blood transfusion patients without increasing the risk of postoperative thrombosis.


Assuntos
Antifibrinolíticos , Perda Sanguínea Cirúrgica , Rivaroxabana , Fusão Vertebral , Idoso , Antifibrinolíticos/uso terapêutico , Humanos , Vértebras Lombares , Estudos Prospectivos , Rivaroxabana/uso terapêutico , Ácido Tranexâmico , Resultado do Tratamento
14.
Medicine (Baltimore) ; 99(37): e22069, 2020 Sep 11.
Artigo em Inglês | MEDLINE | ID: mdl-32925743

RESUMO

OBJECTIVE: Long-segment spinal fusion surgery was associated with substantial perioperative blood loss which may increase hospitalization expenses and mortality rates. Substantial studies have reported that tranexamic acid (TXA) could reduce blood products and cost after joint arthroplasty surgery. However, there still exists controversy regarding the efficacy of TXA in long-segment spinal fusion surgery. We performed this protocol to design a randomized controlled study to evaluate the efficacy of TXA in decreasing transfusion rate of allogeneic blood products and transfusion cost in degenerative lumbar scoliosis patients. METHODS: This study was carried out as a double-blinded, randomized clinical trial on patients with degenerative lumbar scoliosis who prepared for long-segment spinal fusion surgery from December 2018 to December 2019. It was authorized via the Institutional Review Committee in Southwest Medical University (ky2019225). Eighty patients were divided randomly into 2 groups (Experimental group = 40, control group = 40). The patients in the experimental group received 1000 mg of TXA mixed in 100 mL normal saline as a single dose intravenously over 20 minutes before the skin incision was made. Control group received equivalent normal saline without TXA. Primary outcomes included total blood loss, estimated intraoperative blood loss, hematocrit and hemoglobin decline, postoperative drain amount, intra-/postoperative allogeneic transfusion amount and rate, and total transfusion cost. Secondary outcomes included surgical time, thrombotic complications including deep vein thrombosis and pulmonary embolism. All the needed analyses were implemented through utilizing SPSS for Windows Version 20.0. RESULTS: Table showed the relevant clinical outcomes between experimental group and control group. CONCLUSION: We hypothesized that TXA was effective and safe in reducing blood transfusion and cost in long-segment spinal fusion surgery. TRIAL REGISTRATION: This study protocol was registered in Research Registry (researchregistry5854).


Assuntos
Antifibrinolíticos/uso terapêutico , Transfusão de Sangue , Vértebras Lombares/cirurgia , Escoliose/cirurgia , Fusão Vertebral/métodos , Ácido Tranexâmico/uso terapêutico , Perda Sanguínea Cirúrgica/prevenção & controle , Método Duplo-Cego , Feminino , Humanos , Masculino , Duração da Cirurgia , Complicações Pós-Operatórias , Hemorragia Pós-Operatória/prevenção & controle , Embolia Pulmonar , Fusão Vertebral/efeitos adversos , Trombose Venosa
15.
Medicine (Baltimore) ; 99(34): e21747, 2020 Aug 21.
Artigo em Inglês | MEDLINE | ID: mdl-32846798

RESUMO

BACKGROUND: The safety and efficacy of intravenous tranexamic acid (TXA) in the anterior cruciate ligament (ACL) reconstruction remains controversial. There is an urgent need of studies that efficiently control for confounding, conduct comprehensive and consecutive observation of potential risks of the TXA administration, and investigate its clinical applicability. The purpose of this work is to assess the safety and efficacy of the intravenous TXA in decreasing perioperative blood loss in the patients undergoing ACL reconstruction. METHODS: This randomized, controlled, prospective research was carried out between January 2017 and January 2018. All the patients and their family members signed the informed consent forms, and this current work was authorized via the ethics committee of Nanjing first hospital (registration No.: NJU1003586). A total of 100 patients were divided randomly into 2 group: the control group (n = 50) and study group (n = 50). The study group receives intravenous TXA administration [1 g] before skin incision. The control group receives equivalent normal saline. Primary outcome measures including blood loss, hemoglobin decline, transfusion rate, C-reactive protein, D-dimer value, fibrinogen, prothrombin time, activated partial thromboplastin time, thrombin time, international normalized ratio and erythrocyte sedimentation rate were recorded. The measures of secondary outcomes refer to the clinical data involving the range of motion and postoperative pain score. The pain score was quantified by utilizing the 10-cm scale of visual analog. The pain strength was in the range of 0-10, where 0 is totally no pain and 10 represents the most severe pain. RESULTS: This experiment had strict inclusive criteria and exclusive criteria and a well- regulated intervention. CONCLUSION: Our results can bring a new perspective on the use of TXA after arthroscopically assisted ACL surgery. TRIAL REGISTRATION: This study protocol was registered in Research Registry (researchregistry5798).


Assuntos
Reconstrução do Ligamento Cruzado Anterior/métodos , Antifibrinolíticos/uso terapêutico , Ácido Tranexâmico/uso terapêutico , Antifibrinolíticos/administração & dosagem , Antifibrinolíticos/efeitos adversos , Perda Sanguínea Cirúrgica/estatística & dados numéricos , Transfusão de Sangue/estatística & dados numéricos , Feminino , Humanos , Masculino , Dor Pós-Operatória , Estudos Prospectivos , Amplitude de Movimento Articular , Projetos de Pesquisa , Ácido Tranexâmico/administração & dosagem , Ácido Tranexâmico/efeitos adversos
16.
BMC Pregnancy Childbirth ; 20(1): 481, 2020 Aug 24.
Artigo em Inglês | MEDLINE | ID: mdl-32838744

RESUMO

BACKGROUND: The world's understanding of COVID-19 continues to evolve as the scientific community discovers unique presentations of this disease. This case report depicts an unexpected intraoperative coagulopathy during a cesarean section in an otherwise asymptomatic patient who was later found to have COVID-19. This case suggests that there may be a higher risk for intrapartum bleeding in the pregnant, largely asymptomatic COVID-positive patient with more abnormal COVID laboratory values. CASE: The case patient displayed D-Dimer elevations beyond what is typically observed among this hospital's COVID-positive peripartum population and displayed significantly more oozing than expected intraoperatively, despite normal prothrombin time, international normalized ratio, fibrinogen, and platelets. CONCLUSION: There is little published evidence on the association between D-Dimer and coagulopathy among the pregnant population infected with SARS-CoV-2. This case report contributes to the growing body of evidence on the effects of COVID-19 in pregnancy. A clinical picture concerning for intraoperative coagulopathy may be associated with SARS-CoV-2 infection during cesarean sections, and abnormal COVID laboratory tests, particularly D-Dimer, may help identify the patients in which this presentation occurs.


Assuntos
Transtornos da Coagulação Sanguínea/sangue , Perda Sanguínea Cirúrgica , Apresentação Pélvica/cirurgia , Cesárea , Infecções por Coronavirus/sangue , Pneumonia Viral/sangue , Complicações Hematológicas na Gravidez/sangue , Complicações Infecciosas na Gravidez/sangue , Adulto , Antifibrinolíticos/uso terapêutico , Betacoronavirus , Transtornos da Coagulação Sanguínea/tratamento farmacológico , Transtornos da Coagulação Sanguínea/metabolismo , Proteína C-Reativa/metabolismo , Cauterização , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/metabolismo , Feminino , Produtos de Degradação da Fibrina e do Fibrinogênio/metabolismo , Fibrinogênio/metabolismo , Hemostasia Cirúrgica , Humanos , Coeficiente Internacional Normatizado , Metilergonovina/uso terapêutico , Oligo-Hidrâmnio , Ocitócicos/uso terapêutico , Ocitocina/uso terapêutico , Pandemias , Contagem de Plaquetas , Pneumonia Viral/diagnóstico , Pneumonia Viral/metabolismo , Gravidez , Complicações Hematológicas na Gravidez/tratamento farmacológico , Complicações Hematológicas na Gravidez/metabolismo , Complicações Infecciosas na Gravidez/diagnóstico , Complicações Infecciosas na Gravidez/metabolismo , Tempo de Protrombina , Ácido Tranexâmico/uso terapêutico , Inércia Uterina/tratamento farmacológico
17.
Am J Case Rep ; 21: e926623, 2020 Aug 18.
Artigo em Inglês | MEDLINE | ID: mdl-32807764

RESUMO

BACKGROUND COVID-19 was declared a pandemic in March 2020 in the United States. It has been associated with high mortality and morbidity all over the world. COVID-19 can cause a significant inflammatory response leading to coagulopathy and this hypercoagulable state has been associated with worse clinical outcomes in these patients. The published data regarding the presence of lupus anticoagulant in critically ill COVID-19-positive patients is limited and indicates varying conclusions so far. CASE REPORT Here, we present a case of a 31-year-old man who was admitted to the hospital with COVID-19 pneumonia, complicated with superadded bacterial empyema and required video-assisted thoracoscopic surgery with decortication. This patient also had prolonged prothrombin time on preoperative labs, which was not corrected with mixing study. Further workup detected positive lupus anticoagulant and anti-cardiolipin IgM along with alteration in other coagulation factor levels. The patient was treated with fresh frozen plasma and vitamin K before surgical intervention. He had an uneventful surgical course. He received prophylactic-dose low molecular weight heparin for venous thromboembolism prophylaxis and did not experience any thrombotic events while hospitalized. CONCLUSIONS COVID-19 infection creates a prothrombotic state in affected patients. The formation of micro-thrombotic emboli results in significantly increased mortality and morbidity. Routine anticoagulation with low molecular weight heparin can prevent thrombotic events and thus can improve patient outcomes. In patients with elevated prothrombin time, lupus anticoagulant/anti-cardiolipin antibody-positivity should be suspected, and anticoagulation prophylaxis should be continued perioperatively for better outcomes.


Assuntos
Betacoronavirus , Infecções por Coronavirus/complicações , Empiema Pleural/virologia , Inibidor de Coagulação do Lúpus/sangue , Pneumonia Viral/complicações , Adulto , Antifibrinolíticos/uso terapêutico , Cardiolipinas/imunologia , Tubos Torácicos , Infecções por Coronavirus/diagnóstico , Empiema Pleural/diagnóstico por imagem , Empiema Pleural/terapia , Humanos , Imunoglobulina M/sangue , Coeficiente Internacional Normatizado , Masculino , Pandemias , Tempo de Tromboplastina Parcial , Plasma , Pneumonia Viral/diagnóstico , Tempo de Protrombina , Tomografia Computadorizada por Raios X , Tromboembolia Venosa/prevenção & controle , Vitamina K/uso terapêutico
18.
Clin Drug Investig ; 40(9): 789-797, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32661913

RESUMO

BACKGROUND: Hemoptysis, a common symptom of different lung diseases, engenders shortness of breath and increased mortality. Tranexamic acid (TXA), a commonly used antifibrinolytic agent, can control bleeding. However, the effects of its use on pulmonary hemorrhage have rarely been discussed. OBJECTIVE: We conducted this systematic review and meta-analysis of randomized controlled trials (RCTs) of TXA for hemoptysis to investigate its effectiveness in reducing hemoptysis volume and duration. METHODS: We searched the Cochrane Library, Embase, PubMed (including MEDLINE), and Scopus databases for relevant RCTs. Two of the authors individually assessed study quality by using the Cochrane risk-of-bias (RoB) 2.0 tool, and the pooled results were evaluated using RevMan 5.3. RESULTS: We obtained 617 articles, of which four RCTs met eligibility criteria. The pooled results demonstrated no significant differences in bleeding duration or hemoptysis resolution between the TXA and control groups. Nevertheless, TXA use reduced bleeding volume (mean difference [MD] = - 56.21 mL; 95% CI - 94.70 to - 17.72 mL), further intervention risk (Peto odds ratio = 0.24; 95% CI 0.08-0.67; I2 = 0%), and length of hospital stay (MD = - 1.62 days; 95% CI - 2.93 to - 0.31; I2 = 0%). CONCLUSION: TXA use was observed to reduce bleeding volume, further intervention risk, and length of hospital stay in patients with hemoptysis; however, our results may have low statistical power because of limited sample size. Additional large-scale RCTs are thus warranted to confirm the effectiveness and safety of TXA use.


Assuntos
Antifibrinolíticos/uso terapêutico , Hemoptise/prevenção & controle , Ácido Tranexâmico/uso terapêutico , Hemoptise/etiologia , Hemoptise/mortalidade , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto
19.
Br J Anaesth ; 125(3): 336-345, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32620262

RESUMO

BACKGROUND: Tranexamic acid (TXA) reduces blood loss and transfusion in paediatric craniosynostosis surgery. The hypothesis is that low-dose TXA, determined by pharmacokinetic modelling, is non-inferior to high-dose TXA in decreasing blood loss and transfusion in children. METHODS: Children undergoing craniosynostosis surgery were enrolled in a two-centre, prospective, double-blind, randomised, non-inferiority controlled trial to receive high TXA (50 mg kg-1 followed by 5 mg kg-1 h-1) or low TXA (10 mg kg-1 followed by 5 mg kg-1 h-1). Primary outcome was blood loss. Low dose was determined to be non-inferior to high dose if the 95% confidence interval (CI) for the mean difference in blood loss was above the non-inferiority margin of -20 ml kg-1. Secondary outcomes were transfusion, TXA plasma concentrations, and biological markers of fibrinolysis and inflammation. RESULTS: Sixty-eight children were included. Values were non-inferior regarding blood loss (39.4 [4.4] vs 40.3 [6.2] ml kg-1 [difference=0.9; 95% CI: -14.2, 15.9]) and blood transfusion (21.3 [1.6] vs 23.6 [1.5] ml kg-1 [difference=2.3; 95% CI: -2.1, 6.7]) between high-dose (n=32) and low-dose (n=34) groups, respectively. The TXA plasma concentrations during surgery averaged 50.2 (8.0) and 29.6 (7.6) µg ml-1. There was no difference in fibrinolytic and inflammatory biological marker concentrations. No adverse events were observed. CONCLUSIONS: Tranexamic acid 10 mg kg-1 followed by 5 mg kg-1 h-1 is not less effective than a higher dose of 50 mg kg-1 and 5 mg kg-1 h-1 in reducing blood loss and transfusion in paediatric craniosynostosis surgery. CLINICAL TRIAL REGISTRATION: NCT02188576.


Assuntos
Antifibrinolíticos/uso terapêutico , Craniossinostoses/cirurgia , Ácido Tranexâmico/uso terapêutico , Perda Sanguínea Cirúrgica/prevenção & controle , Pré-Escolar , Relação Dose-Resposta a Droga , Método Duplo-Cego , Feminino , Humanos , Lactente , Masculino , Estudos Prospectivos
20.
Cochrane Database Syst Rev ; 7: CD013651, 2020 07 23.
Artigo em Inglês | MEDLINE | ID: mdl-32700364

RESUMO

BACKGROUND: Within the context of heavy menstrual bleeding, pandemics impact upon women's assessment and treatment by healthcare providers. OBJECTIVES: To summarise the evidence from Cochrane Reviews evaluating interventions for heavy menstrual bleeding that are commonly available during pandemics. METHODS: We sought published Cochrane Reviews, evaluating interventions that can continue during pandemics for women with heavy menstrual bleeding with no known underlying cause. We identified Cochrane Reviews by searching the Cochrane Database of Systematic Reviews in June 2020. The primary outcome was menstrual bleeding. Secondary outcomes included quality of life, patient satisfaction, side effects, and serious adverse events. We undertook the selection of systematic reviews, data extraction, and quality assessment in duplicate. We resolved any disagreements by discussion. We assessed review quality using the Assessing the Methodological Quality of Systematic Reviews (AMSTAR) 2 tool, and the certainty of the evidence for each outcome using GRADE methods. MAIN RESULTS: We included four Cochrane Reviews, with 11 comparisons, data from 44 randomised controlled trials (RCTs), and 3196 women. We assessed all the reviews to be high quality. Non-steroidal anti-inflammatory drugs (NSAIDs) NSAIDs may be more effective in reducing heavy menstrual bleeding than placebo (mean difference (MD) -124 mL per cycle, 95% confidence interval (CI) -186 to -62 mL per cycle; 1 RCT, 11 women; low-certainty evidence). Mefenamic acid may be similar to naproxen (MD 21 mL per cycle, 95% CI -6 to 48 mL per cycle; 2 RCTs, 61 women; low-certainty evidence), and NSAIDs may be similar to combined hormonal contraceptives for heavy menstrual bleeding (MD 25 mL per cycle, 95% CI -22 to 73 mL per cycle; 1 RCT, 26 women; low-certainty evidence). NSAIDs may be be less effective in reducing menstrual bleeding than antifibrinolytics (relative risk (RR) 0.70, 95% CI 0.58 to 0.85; 2 RCTs, 161 women; low-certainty evidence). We are uncertain whether NSAIDs reduce menstrual blood loss more than short-cycle progestogens (RR 0.80, 95% CI 0.49 to 1.32; 1 RCT 32 women; very low-certainty evidence). Antifibrinolytics Antifibrinolytics appear to be more effective in reducing heavy menstrual bleeding than placebo (MD -53 mL per cycle, 95% CI -63 to -44 mL per cycle; 4 RCTs, 565 women; moderate-certainty evidence). Antifibrinolytics may be similar to placebo on the incidence of side effects (RR 1.05, 95% CI 0.93 to 1.18; 1 RCT, 297 women; low-certainty evidence), and they are probably similar on the incidence of serious adverse events (thrombotic events; RR 0.10, 95% CI 0.00 to 2.46; 2 RCT, 468 women; moderate-certainty evidence). Antifibrinolytics may be more effective in reducing heavy menstrual bleeding than short-cycle progestogen (MD -111 mL per cycle, 95% CI -178 mL to -44 mL per cycle; 1 RCT, 46 women; low-certainty evidence). We are uncertain whether antifibrinolytics are similar to short-cycle progestogens on quality of life (RR 1.67, 95% CI 0.76 to 3.64; 1 RCT, 44 women; very low-certainty evidence), patient satisfaction (RR 0.91, 95% CI 0.59 to 1.39; 1 RCT, 42 women; very low-certainty evidence), or side effects (RR 0.85, 95% CI 0.65 to 1.12; 3 RCTs, 211 women; very low-certainty evidence). We are uncertain whether antifibrinolytics are more effective in reducing heavy menstrual bleeding when compared with long-cycle progestogen (MD -9 points per cycle, 95% CI -30 to 12 points per cycle; 2 RCTs, 184 women; low-certainty evidence). Antifibrinolytics may increase self-reported improvement in menstrual bleeding when compared with long-cycle medroxyprogesterone acetate (RR 1.32, 95% CI 1.08 to 1.61; 1 RCT, 94 women; low-certainty evidence). Antifibrinolytics may be similar to long-cycle progestogens on quality of life (MD 5, 95% CI -2.49 to 12.49; 1 RCT, 90 women; low-certainty evidence). We are uncertain whether antifibrinolytics are similar to long-cycle progestogens on side effects (RR 0.58, 95% CI 0.33 to 1.00; 2 RCTs, 184 women; very low-certainty evidence). There were no trials comparing antifibrinolytics to combined hormonal contraceptives. Combined hormonal contraceptives Combined hormonal contraceptives appear to be more effective for heavy menstrual bleeding than placebo or no treatment (RR 13.25, 95% CI 2.94 to 59.64; 2 RCTs, 363 women; moderate-certainty evidence). Combined hormonal contraceptives are probably similar to placebo on the incidence of side effects (RR 1.53, 95% CI 0.90 to 2.60; 2 RCTs, 411 women; moderate-certainty evidence). Progestogens There were no trials comparing progestogens to placebo. Limitations in the evidence included risk of bias in the primary RCTs, inconsistency between the primary RCTs, and imprecision in effect estimates. AUTHORS' CONCLUSIONS: There is moderate-certainty evidence that antifibrinolytics and combined hormonal contraceptives reduce heavy menstrual bleeding compared with placebo. There is low-certainty evidence that NSAIDs reduce heavy menstrual bleeding compared with placebo. There is low-certainty evidence that antifibrinolytics are more effective in reducing heavy menstrual bleeding when compared with NSAIDs and short-cycle progestogens, but we are unable to draw conclusions about the effects of antifibrinolytics compared to long-cycle progestogens, on low-certainty evidence.


Assuntos
Menorragia/tratamento farmacológico , Pandemias , Anti-Inflamatórios não Esteroides/uso terapêutico , Antifibrinolíticos/uso terapêutico , Anticoncepcionais Orais Hormonais/uso terapêutico , Feminino , Humanos , Ácido Mefenâmico/uso terapêutico , Placebos/uso terapêutico , Progestinas/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Literatura de Revisão como Assunto
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