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Journal of Clinical Anesthesia Jun 2024To assess how kidney disease is handled in randomized trials evaluating the safety and efficacy of perioperative tranexamic acid, and to evaluate its effects across... (Meta-Analysis)
Meta-Analysis
STUDY OBJECTIVE
To assess how kidney disease is handled in randomized trials evaluating the safety and efficacy of perioperative tranexamic acid, and to evaluate its effects across levels of kidney function.
DESIGN
Systematic review and meta-analysis of randomized controlled trials.
SETTING
We screened studies from a previous comprehensive systematic review, and updated its search of PubMed, Embase, and Cochrane CENTRAL to July 31, 2023.
PATIENTS
Patients undergoing non-obstetric surgery.
INTERVENTIONS
Intravenous tranexamic acid compared to placebo or usual care without tranexamic acid.
MEASUREMENT
We summarized the handling of kidney disease in eligibility criteria, dose adjustments for kidney function, and effects of tranexamic acid on thrombotic events, seizures, and bleeding by subgroups of kidney function.
MAIN RESULTS
We evaluated 300 trials with 53,085 participants; 45,958 participants (86.6%) were enrolled in 228 trials (76.0%) that explicitly excluded patients with kidney disease. Definitions of kidney diseased used for exclusion varied widely. Most were non-specific and some corresponded to mild disease. Only 5 trials adjusted dosing for kidney function. Meta-analysis of two large trials found tranexamic acid unlikely to substantially increase or decrease the occurrence of thrombotic events in patients with eGFR <60 mL/min/1.73m (RR, 0.95; 95% CI: 0.83 to 1.07) or ≥ 60 mL/min/1.73m (RR, 1.00; 95% CI, 0.91 to 1.11; P for subgroup difference = 0.47), but both trials excluded patients with severe kidney disease. No analysis could be performed regarding seizure risk. One large trial in noncardiac surgery reported similar reduction in bleeding across subgroups of kidney function but excluded patients with creatinine clearance <30 mL/min.
CONCLUSIONS
The large evidence base supporting perioperative tranexamic acid suffers from broad and unjustified exclusion of patients with kidney disease. Typical perioperative dosing of tranexamic acid is likely safe and effective in patients with creatinine clearance >30 mL/min, but effects in more severe kidney disease are unknown.
Topics: Humans; Antifibrinolytic Agents; Creatinine; Hemorrhage; Kidney Diseases; Tranexamic Acid
PubMed: 38387241
DOI: 10.1016/j.jclinane.2024.111417 -
Current Problems in Cardiology Aug 2023
Meta-Analysis Review
Head-to-head Comparison Between Direct Oral Anticoagulants and Vitamin K Antagonists for Chronic Thromboembolic Pulmonary Hypertension: A Systematic Review and Meta-Analysis.
Topics: Humans; Hypertension, Pulmonary; Anticoagulants; Fibrinolytic Agents; Vitamin K; Administration, Oral; Atrial Fibrillation
PubMed: 35500739
DOI: 10.1016/j.cpcardiol.2022.101232 -
Journal of the Formosan Medical... May 2024The introduction of non-vitamin K antagonist oral anticoagulants (NOACs), with a non-inferior or superior clinical efficacy profile compared to vitamin K antagonists... (Meta-Analysis)
Meta-Analysis Comparative Study
BACKGROUND
The introduction of non-vitamin K antagonist oral anticoagulants (NOACs), with a non-inferior or superior clinical efficacy profile compared to vitamin K antagonists (VKAs), has significantly improved the safety profile and treatment adherence of patients with non-valvular atrial fibrillation (AF). However, few studies have compared the effectiveness and safety of NOACs. Therefore, we conducted this systematic review and network meta-analysis to compare the safety and clinical effectiveness of NOACs and VKAs in patients with non-valvular AF.
METHODS
An online bibliographic search was conducted to retrieve real-world evidence studies published between January 2019 and June 2022.
RESULTS
Dabigatran was associated with lower risks of major bleeding, ischemic stroke, and intracranial hemorrhage than warfarin. Among the NOACs, only dabigatran had a lower risk of all-cause mortality than warfarin. Dabigatran was also associated with lower risks of major bleeding and intracranial hemorrhage than rivaroxaban.
CONCLUSION
Our meta-analysis confirms that dabigatran's real-world safety and clinical effectiveness align with the results of pivotal clinical trials.
Topics: Humans; Atrial Fibrillation; Warfarin; Anticoagulants; Network Meta-Analysis; Dabigatran; Administration, Oral; Hemorrhage; Stroke; Rivaroxaban; Vitamin K
PubMed: 37996330
DOI: 10.1016/j.jfma.2023.10.014 -
European Journal of Clinical... Oct 2023Cancer is a well-known risk factor for venous thromboembolism (VTE). A combined strategy of D-dimer testing and clinical pre-test probability is usually used to exclude... (Review)
Review
BACKGROUND
Cancer is a well-known risk factor for venous thromboembolism (VTE). A combined strategy of D-dimer testing and clinical pre-test probability is usually used to exclude VTE. However, its effectiveness is diminished in cancer patients due to reduced specificity, ultimately leading to a decreased clinical utility. This review article seeks to provide a comprehensive summary of how to interpret D-dimer testing in cancer patients.
METHODS
In accordance with PRISMA standards, literature pertaining to the diagnostic and prognostic significance of D-dimer testing in cancer patients was carefully chosen from reputable sources such as PubMed and the Cochrane databases.
RESULTS
D-dimers have not only a diagnostic value in ruling out VTE but can also serve as an aid for rule-in if their values exceed 10-times the upper limit of normal. This threshold allows a diagnosis of VTE in cancer patients with a positive predictive value of more than 80%. Moreover, elevated D-dimers carry important prognostic information and are associated with VTE reoccurrence. A gradual increase in risk for all-cause death suggests that VTE is also an indicator of biologically more aggressive cancer types and advanced cancer stages. Considering the lack of standardization for D-dimer assays, it is essential for clinicians to carefully consider the variations in assay performance and the specific test characteristics of their institution.
CONCLUSIONS
Standardizing D-dimer assays and developing modified pretest probability models specifically for cancer patients, along with adjusted cut-off values for D-dimer testing, could significantly enhance the accuracy and effectiveness of VTE diagnosis in this population.
Topics: Humans; Fibrin Fibrinogen Degradation Products; Neoplasms; Predictive Value of Tests; Risk Factors; Venous Thromboembolism; Biological Assay; Sensitivity and Specificity
PubMed: 37409393
DOI: 10.1111/eci.14060 -
Journal of ISAKOS : Joint Disorders &... Mar 2024Peri-operative blood loss during joint replacement procedures is a modifiable risk factor that impacts wound complications, hospital stay and total costs. Tranexamic... (Review)
Review
Tranexamic acid reduces perioperative blood loss and postoperative hemoglobin loss during total ankle arthroplasty: A systematic review and meta-analysis of clinical comparative studies.
IMPORTANCE
Peri-operative blood loss during joint replacement procedures is a modifiable risk factor that impacts wound complications, hospital stay and total costs. Tranexamic acid (TXA) is an anti-fibrinolytic that has been widely used in orthopedic surgery, but its efficacy in the setting of total ankle arthroplasty (TAA) has not been quantified to date.
AIM
The purpose of this systematic review and meta-analysis was to evaluate the efficacy and safety of administering TXA in patients undergoing TAA.
EVIDENCE REVIEW
The Medline, Embase and Cochrane library databases were systematically reviewed using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Five comparative studies examining blood loss following administration of TXA for patients undergoing TAA were included. The outcome measures of interest were blood loss, reduction in hemoglobin concentration, transfusion requirements, total complications and wound complications.
FINDINGS
In total, 194 patients received TXA and 187 patients did not receive TXA while undergoing TAA. Based on the common-effects model for total blood loss for the TXA group versus control, the standardized mean difference (SMD) was -0.7832 (95% CI, -1.1544, -0.4120; P < 0.0001), in favor of lower total blood loss for TXA. Based on the random-effects model for reduction in hemoglobin for the TXA group versus control, the SMD was -0.9548 (95% CI, -1.7850, -0.1246; P = 0.0242) in favor of lower hemoglobin loss for TXA. Based on the random-effects model for total complications for the TXA group versus control, the risk ratio was 0.512 (95% CI, 0.1588, 1.6512; P = 0.1876), in favor of lower total complications for TXA but this was not statistically significant.
CONCLUSIONS
This current review demonstrated that administration of TXA led to a reduction in blood loss and hemoglobin loss without an increased risk of the development of venous thromboembolism in patients undergoing TAA. No difference was observed with respect to total complication rates between the TXA cohort and the control group. TXA appears to be an effective hemostatic agent in the setting of TAA, but further studies are necessary to identify the optimal timing, dosage and route of TXA during TAA.
LEVEL OF EVIDENCE
III.
PubMed: 38521460
DOI: 10.1016/j.jisako.2024.03.009 -
Neurosurgical Review Apr 2024Antifibrinolytics have gained increasing attention in minimizing blood loss and mitigating the risks associated with massive transfusions, including infection and... (Meta-Analysis)
Meta-Analysis
Antifibrinolytics have gained increasing attention in minimizing blood loss and mitigating the risks associated with massive transfusions, including infection and coagulopathy in pediatric patients undergoing spine surgery. Nevertheless, the selection of optimal agent is still a matter of debate. We aim to review the utility of these agents and compare the efficacy of antifibrinolytics in pediatric and adolescent spine surgeries. A comprehensive search was performed in Scopus, Web of Science, and MEDLINE databases for relevant works. Studies providing quantitative data on predefined outcomes were included. Primary outcome was perioperative bleeding between the groups. Secondary outcomes included transfusion volume, rate of complications, and operation time. Twenty-eight studies were included in the meta-analysis incorporating 2553 patients. The use of Tranexamic acid (RoM: 0.71, 95%CI: [0.62-0.81], p < 0.001, I = 88%), Aprotinin (RoM: 0.54, 95%CI: [0.46-0.64], p < 0.001, I = 0%), and Epsilon-aminocaproic acid (RoM: 0.71, 95%CI: [0.62-0.81], p < 0.001, I = 60%) led to a 29%, 46%, and 29% reduction in perioperative blood loss, respectively. Network meta-analysis revealed higher probability of efficacy with Tranexamic acid compared to Epsilon-aminocaproic acid (P score: 0.924 vs. 0.571). The rate of complications was not statistically different between each two antifibrinolytic agent or antifibrinolytics compared to placebo or standard of care. Our network meta-analysis suggests a superior efficacy of all antifibrinolytics compared to standard of care/placebo in reducing blood loss and transfusion rate. Further adequately-powered randomized clinical trials are recommended to reach definite conclusion on comparative performance of these agents and to also provide robust objective assessments and standardized outcome data and safety profile on antifibrinolytics in pediatric and adolescent pediatric surgeries.
Topics: Humans; Antifibrinolytic Agents; Child; Blood Loss, Surgical; Network Meta-Analysis; Spine; Tranexamic Acid; Adolescent; Blood Transfusion; Neurosurgical Procedures; Treatment Outcome
PubMed: 38644447
DOI: 10.1007/s10143-024-02424-x -
Revista Espanola de Anestesiologia Y... May 2024We performed a meta-analysis to assess the effectiveness and safety of tranexamic acid in patients with traumatic brain injury (TBI). (Meta-Analysis)
Meta-Analysis
BACKGROUND
We performed a meta-analysis to assess the effectiveness and safety of tranexamic acid in patients with traumatic brain injury (TBI).
METHODS
We searched the literature for articles evaluating the effectiveness and safety of tranexamic acid (TXA) in TBI published between January 2012 and January 2021, and identified 8 studies with a total of 10860 patients: 5660 received TXA and 5200 served as controls. We used a dichotomous or continuous approach with a random or fixed-effect model to assess the efficacy and safety of TXA in TBI, and calculated the mean difference (MD) and odds ratio (OR) with the corresponding 95% confidence interval.
RESULTS
In patients with TBI, early administration of TXA was associated with a greater relative benefit (MD -2.45; 95% CI = -4.78 to -0.12; p=0.04) and less total haematoma expansion (MD - 2.52; 95% CI = -4.85 to -0.19; p=0.03) compared to controls. There were no statistically significant differences in mortality (OR 0.94; 95% CI=0.85-1.03; p=0.18), presence of progressive haemorrhage (OR 0.75; 95% CI=0.56-1.01; p=0.06), need for neurosurgery (OR 1.15; 95% CI=0.66-1.98; p=0.63), high Disability Rating Scale score (OR 0.90; 95% CI=0.56-1.45; p=0.68), and incidence of ischaemic or thromboembolic complications (OR 1.34; 95% CI=0.33-5.46; p=0.68) between TBI patients treated with TXA and controls.
CONCLUSIONS
Early administration of TXA in TBI patients may have a greater relative benefit and may inhibit haematoma expansion. There were no significant differences in mortality, presence of progressive haemorrhage, need for neurosurgery, high Disability Rating Scale score, and incidence of ischaemic or thromboembolic complications between TBI patients treated with TXA and controls. Further studies are needed to validate these results.
Topics: Tranexamic Acid; Brain Injuries, Traumatic; Humans; Antifibrinolytic Agents; Treatment Outcome
PubMed: 38387502
DOI: 10.1016/j.redare.2024.02.013 -
JBJS Reviews Jun 2024Total joint arthroplasty (TJA) is often associated with significant blood loss, leading to complications such as acute anemia and increased risk of infection and... (Comparative Study)
Comparative Study Meta-Analysis
BACKGROUND
Total joint arthroplasty (TJA) is often associated with significant blood loss, leading to complications such as acute anemia and increased risk of infection and mortality. Tranexamic acid (TXA), an antifibrinolytic agent, has been recognized for effectively reducing blood loss during TJA. This systematic review and network meta-analysis aims to evaluate the efficacy and safety of oral TXA compared with other administration routes in TJA.
METHODS
Adhering to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, a comprehensive literature search was conducted across multiple databases, including PubMed, Scopus, Embase, and Web of Science, focusing on randomized clinical trials involving oral TXA in TJA. The studies were assessed for quality using the Cochrane risk assessment scale. Data synthesis involved network meta-analyses, comparing outcomes including hemoglobin drop, estimated blood loss (EBL), transfusion rate, and deep vein thrombosis (DVT) rate.
RESULTS
Our comprehensive literature search incorporated 39 studies with 7,538 participants, focusing on 8 TXA administration methods in TJA. The combination of oral and intra-articular (oral + IA) TXA markedly reduced hemoglobin drop more effectively than oral, intravenous (IV), and IA alone, but the difference was not significant. Oral + IA TXA significantly reduced EBL more effectively than oral + IV, IA + IV, and oral, IV, and IA alone. Perioperative transfusion rates with oral + IA TXA was significantly lower than that of oral, IA, and IV alone. The DVT rate with oral + IA was significantly lower than that with all other routes, including oral + IV, IA + IV, and oral, IA, and IV alone.
CONCLUSION
Oral TXA, particularly in combination with IA administration, demonstrates significantly higher efficacy in reducing blood loss and transfusion rates in TJA, with a safety profile comparable with that of other administration routes. The oral route, offering lower costs and simpler administration, emerges as a viable and preferable option in TJA procedures.
LEVEL OF EVIDENCE
Level I. See Instructions for Authors for a complete description of levels of evidence.
Topics: Humans; Administration, Oral; Antifibrinolytic Agents; Arthroplasty, Replacement; Blood Loss, Surgical; Network Meta-Analysis; Tranexamic Acid; Treatment Outcome
PubMed: 38889241
DOI: 10.2106/JBJS.RVW.23.00248 -
Revista Espanola de Cardiologia... Sep 2023Direct oral anticoagulant (DOAC) therapy has been shown to be safe and effective in patients with atrial fibrillation (AF). However, outcomes in AF patients with... (Meta-Analysis)
Meta-Analysis
INTRODUCTION AND OBJECTIVES
Direct oral anticoagulant (DOAC) therapy has been shown to be safe and effective in patients with atrial fibrillation (AF). However, outcomes in AF patients with bioprosthetic valves are unclear, as this population has been underrepresented in clinical trials. The aim of this study was to assess the safety and efficacy of DOACs in this population based on the existing published literature.
METHODS
A systematic search and review were conducted to identify randomized clinical trials and comparative observational studies published from 2017 to January 2022 that compared DOACs and vitamin K antagonists (VKAs) in AF patients with bioprosthetic valves. Hazard ratios (HR) were collected to compare the 2 treatments in terms of cardiovascular and all-cause mortality, stroke/systemic embolism, and major bleeding. A meta-analysis combining the results was performed.
RESULTS
We included 12 studies (30 283 patients). DOACs and VKAs were compared based on HRs at the 95% confidence interval. DOAC therapy was associated with a significant 9% reduction in all-cause mortality (HR, 0.91; 95%CI, 0.85-0.97; P=.0068; I=8%), with no significant differences in the risk of stroke/systemic embolism (HR, 0.87; 95%CI, 0.67-1.14; P=.29; I=45%) or major bleeding (HR, 0.82; 95%CI, 0.67-1.00; P=.054; I=48.7%).
CONCLUSIONS
DOAC therapy in AF patients with bioprosthetic valves may be associated with a significant reduction in all-cause mortality, with no reduction in the efficacy of stroke/systemic embolism prevention or increase in major bleeding risk.
Topics: Humans; Atrial Fibrillation; Anticoagulants; Hemorrhage; Stroke; Embolism; Administration, Oral; Vitamin K
PubMed: 36804556
DOI: 10.1016/j.rec.2023.02.002 -
Cancer Reports (Hoboken, N.J.) Jan 2024The significant role of red blood cell distribution width (RDW) and D-Dimer as prognostic factors in patients with some blood malignancies has been reported recently. (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The significant role of red blood cell distribution width (RDW) and D-Dimer as prognostic factors in patients with some blood malignancies has been reported recently.
AIM
We designed and performed a meta-analysis to investigate the prognostic roles of RDW and D-Dimer in subjects with diffuse large B-cell lymphoma (DLBCL).
MATERIALS AND METHODS
We systematically reviewed PubMed-Medline, SCOPUS, EMBASE, Web of Science Core Collection, and Google Scholar up to the present to look for publications on prognostic effects of RDW and D-Dimer in DLBCL patients. For investigation of the associations between RDW and D-Dimer with the overall survival (OS) and progression-free survival (PFS) of the DLBCL cases, hazard ratio (HR) with 95% confidence intervals (CIs) was used.
RESULTS
We included 13 eligible studies in the present meta-analysis. The results of pooled analysis showed that increased levels of RDW was related to poor OS (HR = 2.01, 95% CI: 1.62-2.48, p value <.01, I = 0%) and poor PFS (HR = 1.52, 95% CI: 1.24-1.85, p value <.01, I = 16%) among the DLBCL patients. Similarly, a significant relationship was found between increased D-Dimer and poor OS (HR = 2.30, 95% CI: 1.03-5.14, p value <.05, I = 95%) of the DLBCL patients as well. In addition, there was no significant heterogeneity in OS (p value H = 0.65) and PFS (p value H = 0.31) related to RDW among studies included in the meta-analysis.
CONCLUSION
Our finding clearly confirmed that elevated RDW levels and D-Dimer were associated with adverse OS and PFS in DLBCL.
Topics: Humans; Erythrocyte Indices; Erythrocytes; Fibrin Fibrinogen Degradation Products; Lymphoma, Large B-Cell, Diffuse; Prognosis
PubMed: 37997648
DOI: 10.1002/cnr2.1936