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A scoping review protocol on active drug monitoring of direct oral anticoagulants on vulnerable patient groups to detect potential adverse risks 针对弱势患者群体直接口服抗凝药物的活性药物监测以发现潜在不良风险的范围审查方案
Thrombosis Update Pub Date : 2025-09-04 DOI: 10.1016/j.tru.2025.100223
Rebecca Vicente-Steijn , Janneke Spiegelenberg , Sanna R. Rijpma , Yvonne M.C. Henskens , Jenneke Leentjens , Gabriëlle Ponjee , An Stroobants
{"title":"A scoping review protocol on active drug monitoring of direct oral anticoagulants on vulnerable patient groups to detect potential adverse risks","authors":"Rebecca Vicente-Steijn ,&nbsp;Janneke Spiegelenberg ,&nbsp;Sanna R. Rijpma ,&nbsp;Yvonne M.C. Henskens ,&nbsp;Jenneke Leentjens ,&nbsp;Gabriëlle Ponjee ,&nbsp;An Stroobants","doi":"10.1016/j.tru.2025.100223","DOIUrl":"10.1016/j.tru.2025.100223","url":null,"abstract":"<div><h3>Background</h3><div>Emerging data show an increased risk of adverse effects (thrombotic or bleeding events) in patients using the direct oral anticoagulants (DOAC) rivaroxaban, apixaban, edoxaban and dabigatran. Although DOAC are prescribed with a fixed-dose and generally do not require routine drug-level monitoring, certain clinical circumstances may require drug-level monitoring to prevent or manage adverse drug effects. Currently, there is limited evidence whether drug-level monitoring is beneficial for specific patient population or clinical circumstances, and the lack of a specific therapeutic window is a huge knowledge gap in clinical practice.</div></div><div><h3>Methods</h3><div>A systematic search of the electronic database Pubmed (including MEDLINE) will be conducted to identify studies on active drug monitoring of DOAC to detect potential adverse events such as bleeding or thrombotic complications. At least two investigators will independently perform a two-stage study selection of the identified studies. The first stage will consist of title and abstract screening while the second stage will consist of a full-text review followed by data extraction. Once completed, a thematic analysis will be conducted to evaluate whether drug-monitoring is beneficial for specific clinical circumstances or at risk patient populations and initial inventory of clinical guidance opportunities by applying target concentrations in DOAC monitoring.</div></div><div><h3>Conclusion</h3><div>We anticipate that this review will summarize available data on monitoring of DOACs used in clinical practice and provide evidence of patients at risk of adverse effects. When available, the application of specific target concentrations for guidance of DOAC treatment for the identified patient populations will be summarized. Addressing this knowledge gap will help guide the development of future clinical trials on monitoring strategies for high risk patients using DOAC.</div></div>","PeriodicalId":34401,"journal":{"name":"Thrombosis Update","volume":"21 ","pages":"Article 100223"},"PeriodicalIF":0.0,"publicationDate":"2025-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145110103","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Thrombophilia in women undergoing medically assisted reproduction – prevalence and clinical consequence 接受医学辅助生殖的妇女的血栓病——患病率和临床后果
Thrombosis Update Pub Date : 2025-09-01 DOI: 10.1016/j.tru.2025.100222
Jesper Strandberg , Anne-Mette Hvas , Jurgita Janukonyté , Søren Risom Kristensen , Ulrik Schiøler Kesmodel , Anette Tarp Hansen
{"title":"Thrombophilia in women undergoing medically assisted reproduction – prevalence and clinical consequence","authors":"Jesper Strandberg ,&nbsp;Anne-Mette Hvas ,&nbsp;Jurgita Janukonyté ,&nbsp;Søren Risom Kristensen ,&nbsp;Ulrik Schiøler Kesmodel ,&nbsp;Anette Tarp Hansen","doi":"10.1016/j.tru.2025.100222","DOIUrl":"10.1016/j.tru.2025.100222","url":null,"abstract":"<div><h3>Introduction</h3><div>In Denmark, 10 % of new-borns are being conceived with the aid of medically assisted reproduction (MAR). MAR can imply induction of high levels of oestradiol, which in turn leads to increased coagulation activity, decreased natural anticoagulant activity, and reduced fibrinolytic activity. Venous thromboembolism (VTE) is therefore a feared complication, especially in women with other risk factors for VTE, such as family history of VTE, previous VTE, or thrombophilia. Thrombophilia screening is advised in women with clinical risk factors of VTE prior to undergoing MAR. Women with thrombophilia should be handled according to current thrombosis prophylaxis guidelines.</div></div><div><h3>Aim</h3><div>The aim of this study was to investigate the prevalence of thrombophilia in women undergoing MAR compared to the general population, to get an overview of the clinical consequences for women with thrombophilia, and to ensure that the national recommendations regarding thrombophilia screening, are being complied with.</div></div><div><h3>Materials and methods</h3><div>A total of 160 women referred from three public fertility clinics, from 1 May 2015 to 1 May 2020, for thrombophilia investigation prior to MAR, were included. Thrombophilia analyses included both the genetic factors and acquired factors.</div></div><div><h3>Results</h3><div>A higher prevalence of heterozygous factor V Leiden (14 %) and protein S deficiency (2 %) was found in our study population as compared with the general Western population.</div></div><div><h3>Conclusion</h3><div>We found a higher prevalence of some thrombophilias in women referred to MAR.</div></div>","PeriodicalId":34401,"journal":{"name":"Thrombosis Update","volume":"20 ","pages":"Article 100222"},"PeriodicalIF":0.0,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145044496","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The risk of venous thromboembolism behind bars 狱中静脉血栓栓塞的风险
Thrombosis Update Pub Date : 2025-09-01 DOI: 10.1016/j.tru.2025.100224
Lucy A. Norris, Emmanouil S. Papadakis (Editors in chief)
{"title":"The risk of venous thromboembolism behind bars","authors":"Lucy A. Norris,&nbsp;Emmanouil S. Papadakis (Editors in chief)","doi":"10.1016/j.tru.2025.100224","DOIUrl":"10.1016/j.tru.2025.100224","url":null,"abstract":"","PeriodicalId":34401,"journal":{"name":"Thrombosis Update","volume":"20 ","pages":"Article 100224"},"PeriodicalIF":0.0,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145104417","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Impacts of the carceral environment on autopsy-verified venous thromboembolism mortality 癌症环境对尸检证实的静脉血栓栓塞死亡率的影响
Thrombosis Update Pub Date : 2025-08-14 DOI: 10.1016/j.tru.2025.100221
Lisette Valenzuela , Muryam Hasan , Nikolas Brandt , Amy Woods , Shamsher Samra , Nona Bhatia , Nicholas Shapiro
{"title":"Impacts of the carceral environment on autopsy-verified venous thromboembolism mortality","authors":"Lisette Valenzuela ,&nbsp;Muryam Hasan ,&nbsp;Nikolas Brandt ,&nbsp;Amy Woods ,&nbsp;Shamsher Samra ,&nbsp;Nona Bhatia ,&nbsp;Nicholas Shapiro","doi":"10.1016/j.tru.2025.100221","DOIUrl":"10.1016/j.tru.2025.100221","url":null,"abstract":"<div><div>Venous thromboembolism (VTE), encompassing deep vein thrombosis and pulmonary embolism, is a leading cause of mortality globally, with increasing incidence in the United States. However, no studies have examined VTE risk factors in carceral settings. This study evaluates VTE-related deaths in jailed and non-jailed populations in Los Angeles County over 16 years (2008–2023). Using death records, we compiled two datasets: one for deaths in Los Angeles County jails (n = 512) and another for deaths in the free population (n = 107,608). VTE cases were identified through keyword searches and reviewed for diagnostic consistency. Statistical analyses compared mortality rates and demographics, and a qualitative review of jailed VTE decedent autopsy records was conducted to identify risk factors linked to incarceration. VTE-related deaths in the jailed population were over three times higher than in the free population (3.5 % vs. 1.1 %, p = 0.0014). Crude mortality rates in jails have risen since 2014, peaking in 2021. Black individuals, while comprising 7.9 % of the county population and 29.4 % of the jail population, accounted for 66.67 % of VTE deaths in jails, highlighting exacerbated racial disparities. Structural and environmental factors in carceral settings, including restricted mobility, antipsychotic medication use, and restraints, likely contribute to elevated risks. Improving restraint use reporting and post-mortem toxicology findings for pulmonary embolism deaths can enhance etiology understanding. Diversion programs for mental health populations and other decarceral approaches, alongside anticoagulant prescriptions, could mitigate VTE risks and reduce health inequities in incarcerated populations.</div></div>","PeriodicalId":34401,"journal":{"name":"Thrombosis Update","volume":"20 ","pages":"Article 100221"},"PeriodicalIF":0.0,"publicationDate":"2025-08-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144904473","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Hospitalizations for bleeding associated with apixaban versus rivaroxaban according to dose in Medicare beneficiaries 根据医疗保险受益人的剂量,阿哌沙班与利伐沙班相关的出血住院
Thrombosis Update Pub Date : 2025-08-07 DOI: 10.1016/j.tru.2025.100220
Luke S. Vest , Seo H. Baik , Fitsum Baye , Kin-Wah Fung , Clement J. McDonald
{"title":"Hospitalizations for bleeding associated with apixaban versus rivaroxaban according to dose in Medicare beneficiaries","authors":"Luke S. Vest ,&nbsp;Seo H. Baik ,&nbsp;Fitsum Baye ,&nbsp;Kin-Wah Fung ,&nbsp;Clement J. McDonald","doi":"10.1016/j.tru.2025.100220","DOIUrl":"10.1016/j.tru.2025.100220","url":null,"abstract":"<div><h3>Introduction</h3><div>Apixaban and rivaroxaban are the most prescribed direct oral anticoagulants, and the safety of different doses in patients at high risk for bleeding is not fully defined. The objective of this study was to compare the rate of hospitalizations due to bleeding in patients prescribed apixaban versus rivaroxaban at specific doses.</div></div><div><h3>Methods</h3><div>We conducted a retrospective cohort study of more than 1.9 million Medicare beneficiaries who filled prescriptions for apixaban or rivaroxaban from 2014 to 2020 using the Medicare Parts A, B, C and D encounter and prescription claims database. The primary outcomes measured were hospitalizations due to bleeding categorized by location (intracranial, gastrointestinal [GI], and other) and all-cause mortality.</div></div><div><h3>Results</h3><div>Among the population studied, 1,022,170 (53 %) filled a prescription for apixaban 5 mg during the study period, followed by rivaroxaban 20 mg (27 %) and rivaroxaban 10 mg (11 %). Compared to the reference group of apixaban 5 mg, combination prescriptions for rivaroxaban 15–20 mg were associated with more than twice the risk of hospitalization due to GI bleeding (hazard ratio [HR] = 2.41, 95 % confidence interval [CI]: 2.15–2.70) and other bleeding (HR = 2.42, 95 % CI: 1.92–3.05) and were associated with a 51 % higher risk of hospitalization due to intracranial bleeding (HR = 1.51, 95 % CI: 1.15–1.98). There were 88,740 (4.6 %) deaths during the study period, with a 27 % increased risk of death associated with prescriptions for apixaban 2.5 mg (HR = 1.27, 95 % CI: 1.24–1.30) and a 19 % decreased risk of death associated with prescriptions for rivaroxaban 10 mg (HR = 0.81, 95 % CI: 0.78–0.85).</div></div><div><h3>Conclusion</h3><div>Rivaroxaban doses of 15 mg and greater were associated with higher bleeding risk. This data may aid clinicians in making an informed decision when prescribing specific doses of apixaban and rivaroxaban, particularly for patients with a high risk of bleeding.</div></div>","PeriodicalId":34401,"journal":{"name":"Thrombosis Update","volume":"20 ","pages":"Article 100220"},"PeriodicalIF":0.0,"publicationDate":"2025-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144852853","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Asymptomatic patients with carotid atherosclerosis present a higher coagulation state compared to healthy subjects 无症状颈动脉粥样硬化患者的凝血状态高于健康人
Thrombosis Update Pub Date : 2025-07-26 DOI: 10.1016/j.tru.2025.100219
Laurie Josset , Mathilde Mura , Mathis Damon , Emma de Cartier d’Yves , Michèle Weiss-Gayet , Anaelle Boreau , Emeraude Rivoire , Nellie Della-Schiava , Anne Long , Sandrine Horman , Antoine Millon , Vincent Pialoux , Amandine Thomas
{"title":"Asymptomatic patients with carotid atherosclerosis present a higher coagulation state compared to healthy subjects","authors":"Laurie Josset ,&nbsp;Mathilde Mura ,&nbsp;Mathis Damon ,&nbsp;Emma de Cartier d’Yves ,&nbsp;Michèle Weiss-Gayet ,&nbsp;Anaelle Boreau ,&nbsp;Emeraude Rivoire ,&nbsp;Nellie Della-Schiava ,&nbsp;Anne Long ,&nbsp;Sandrine Horman ,&nbsp;Antoine Millon ,&nbsp;Vincent Pialoux ,&nbsp;Amandine Thomas","doi":"10.1016/j.tru.2025.100219","DOIUrl":"10.1016/j.tru.2025.100219","url":null,"abstract":"<div><h3>Background</h3><div>In pro-inflammatory conditions, such as atherosclerosis, circulating monocytes may express tissue factor (TF), increasing thromboembolic risk. Regular physical activity (PA) has been shown to modulate hemostasis by reducing fibrinogen concentration and platelet activation, though its effects on coagulation are limited.</div></div><div><h3>Objectives</h3><div>We aim to evaluate the procoagulant and proinflammatory state in asymptomatic patients with atherosclerotic carotid stenosis, compared to healthy subjects and to assess the impact of a 6-month PA intervention.</div></div><div><h3>Methods</h3><div>This study included patients with asymptomatic carotid stenosis and healthy subjects. Patients were randomized into a PA group (6-month individualized PA intervention), and a control group. Blood analyses were performed to assess monocyte phenotype and TF expression by flow cytometry, and coagulation parameters using rotative thromboelastometry.</div></div><div><h3>Results</h3><div>The expression of TF on the surface of circulating monocytes was significantly higher in patients than in healthy subjects (61.9 ± 11.7 % vs 33.7 ± 6.3 %, p &lt; 0.0001), mainly explained by a higher expression on classical monocytes (77.7 ± 9.5 vs 58.3 ± 15.8 %, p &lt; 0.001). Clotting times were lower in patients than in healthy subjects in basal (407.8 77.7 ± 144.6 s vs 615.5 ± 123.4 s p &lt; 0.0001) and proinflammatory (222.4 ± 48.2 s vs 307.8 ± 82.4 s p = 0.003) conditions. A 6-month PA intervention did not induce any modulation of the monocyte phenotype or coagulation parameters of patients with atherosclerosis.</div></div><div><h3>Conclusion</h3><div>Asymptomatic patients with carotid atherosclerosis have a higher proinflammatory and procoagulant profile, suggesting a higher thromboembolic risk. However, home-based PA intervention did not improve their profiles.</div></div>","PeriodicalId":34401,"journal":{"name":"Thrombosis Update","volume":"20 ","pages":"Article 100219"},"PeriodicalIF":0.0,"publicationDate":"2025-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144748937","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Exploring experiences of patients attending an outpatient thrombosis service in Canada 探讨患者参加门诊血栓服务在加拿大的经验
Thrombosis Update Pub Date : 2025-07-14 DOI: 10.1016/j.tru.2025.100218
Gabriela Carrillo-Balam , Tiffany Lee , Stephanie Young
{"title":"Exploring experiences of patients attending an outpatient thrombosis service in Canada","authors":"Gabriela Carrillo-Balam ,&nbsp;Tiffany Lee ,&nbsp;Stephanie Young","doi":"10.1016/j.tru.2025.100218","DOIUrl":"10.1016/j.tru.2025.100218","url":null,"abstract":"<div><h3>Background</h3><div>There is limited information on patients' experiences that influence their satisfaction and perception of the quality of care received at comprehensive thrombosis and anticoagulation management services. However, in order to provide patient-centred care, patients’ input is fundamental. Therefore, we aimed to explore the views and experiences of people who received care at an Adult Outpatient Thrombosis Service to identify aspects that are valued as well as areas for improvement.</div></div><div><h3>Methods</h3><div>This is an analysis of free-text data from an anonymous survey sent to all adult patients who received care from a multidisciplinary Thrombosis Service in Newfoundland and Labrador, Canada between October 2017 and May 2019. Thematic analysis was used to analyze the open-ended free text responses and identify common themes.</div></div><div><h3>Findings</h3><div>In total, 40.7 % (n = 229) of survey respondents (N = 563) provided comments to the free-text question. Respondents made more positive comments than negative comments. Four common themes were identified: feeling seen, heard, and cared for; the information received filled the gap and sometimes missed the mark; service organization and follow-up: smooth for some, frustrating for others; and, accessing care: virtual options, travel burden, and waiting.</div></div><div><h3>Conclusion</h3><div>This analysis highlights the positive effect of receiving clear information and having a respectful patient-provider relationship on patients' perceived quality of care. Conversely, the need for alternative consultation-delivery modes, such as virtual care, was identified as an area of opportunity to improve patients’ care experience.</div></div>","PeriodicalId":34401,"journal":{"name":"Thrombosis Update","volume":"20 ","pages":"Article 100218"},"PeriodicalIF":0.0,"publicationDate":"2025-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144653780","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Thrombin generation remains stable in frozen plasma over long-term storage 凝血酶的生成在冷冻血浆中长期保存是稳定的
Thrombosis Update Pub Date : 2025-07-12 DOI: 10.1016/j.tru.2025.100216
A. Carlo , R. de Laat-Kremers , B. de Laat , M. Ninivaggi
{"title":"Thrombin generation remains stable in frozen plasma over long-term storage","authors":"A. Carlo ,&nbsp;R. de Laat-Kremers ,&nbsp;B. de Laat ,&nbsp;M. Ninivaggi","doi":"10.1016/j.tru.2025.100216","DOIUrl":"10.1016/j.tru.2025.100216","url":null,"abstract":"<div><h3>Background</h3><div>The ST Genesia is a fully automated thrombin generation (TG) device. Measuring TG can be useful for medical purposes as it is an indicator for the bleeding or thrombotic risk of a patient. When measuring TG, it is of utmost importance to be careful with the preanalytical part as it can affect TG. One of the preanalytical steps to be cautious with, is the plasma sample storage temperature and duration.</div></div><div><h3>Methods</h3><div>Citrated blood was collected and centrifuged twice for 10 min at 2840g to obtain platelet poor plasma. Plasma samples were stored directly in the freezer either at −20 °C or at −80 °C. TG was measured with a low, intermediate and high tissue factor concentration (STG-BleedScreen, STG-ThromboScreen and STG-DrugScreen, respectively) in fresh samples and after storage at -20°C and -80°C for 1 day, 1 month, 3 months, 6 months and 12 months. The samples stored at −80 °C were also measured after 18 and 24 months.</div></div><div><h3>Results</h3><div>Freezing platelet poor plasma samples did affect the TG parameters. This observation was independent of the storage temperature and the tissue factor used for triggering TG. Interestingly, TG was not significantly affected by time in storage at −20 °C and −80 °C even up to one year or two years, respectively. Some variation was observed in the samples measured with thrombomodulin, which may have been due to the use of a reagent kit with different lot number.</div></div><div><h3>Conclusion</h3><div>Freezing plasma does affect TG independently of the storage temperature. However, once frozen, the TG does not vary significantly in time even up to one or two years for samples stored at −20 °C and −80 °C, respectively.</div></div>","PeriodicalId":34401,"journal":{"name":"Thrombosis Update","volume":"20 ","pages":"Article 100216"},"PeriodicalIF":0.0,"publicationDate":"2025-07-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144653781","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Reduction in D-dimer levels after treatment with Auxora in patients with severe COVID-19 pneumonia 重症COVID-19肺炎患者用Auxora治疗后d -二聚体水平降低
Thrombosis Update Pub Date : 2025-07-11 DOI: 10.1016/j.tru.2025.100217
Peter C. Hou , Joseph Miller , Charles Bruen , Fady Youssef , Michael J. Schnaus , Kathyrn Brouillette , Raul Mendoza-Ayala , Jeffrey Zhang , Kenneth Stauderman , Sudarshan Hebbar
{"title":"Reduction in D-dimer levels after treatment with Auxora in patients with severe COVID-19 pneumonia","authors":"Peter C. Hou ,&nbsp;Joseph Miller ,&nbsp;Charles Bruen ,&nbsp;Fady Youssef ,&nbsp;Michael J. Schnaus ,&nbsp;Kathyrn Brouillette ,&nbsp;Raul Mendoza-Ayala ,&nbsp;Jeffrey Zhang ,&nbsp;Kenneth Stauderman ,&nbsp;Sudarshan Hebbar","doi":"10.1016/j.tru.2025.100217","DOIUrl":"10.1016/j.tru.2025.100217","url":null,"abstract":"<div><h3>Introduction</h3><div>A phase 2 double-blinded trial (CARDEA) (<span><span>NCT04345614</span><svg><path></path></svg></span>) in patients diagnosed with COVID-19 revealed that intravenous zegocractin treatment (Auxora™) was associated with improved clinical outcomes compared to standard of care (SOC). D-dimer serum level is a biomarker of thrombosis in COVID-19, and elevated levels are directly correlated with a high risk of poor outcomes. Here, we report biomarker analyses from blood samples collected from patients in that study.</div></div><div><h3>Methods</h3><div>Quantification of D-dimer levels was the primary endpoint of the study. Secondary endpoints measured levels of angiopoietin 1 (Ang1), angiopoietin 2 (Ang2), soluble CD25 (sCD25), and renin. CARDEA was conducted in 17 U S. clinical centers. Patients were randomly assigned to receive Auxora plus SOC (n = 143) or placebo plus SOC (n = 141). The medications were administered by a 4-h intravenous infusion at 2.0 mg/kg (1.25 mL/kg) at 0-h and 1.6 mg/kg (1 mL/kg) at 24 h and 48 h.</div></div><div><h3>Findings</h3><div>Patients in the Auxora group had a baseline mean D-dimer value of 2.61 mg/L and those in the placebo group had a value of 2.05 mg/L. Treatment with Auxora resulted in a statistically significant decrease in D-dimer levels within the first 72 h compared to placebo (delta = −0.92; [95 % CI: −1.82, −0.02]; <em>p</em> &lt; 0.046). The decrease in D-dimer levels correlated with an increase in imputed PaO<sub>2</sub>/FiO<sub>2</sub> at 72 h (r: −0.193; <em>p</em> &lt; 0.05) and improved clinical status at 168 h (r: 0.218, <em>p</em> &lt; 0.01). Auxora treatment reduced levels of Ang2 and sCD25, and increased Ang1 levels compared to placebo.</div></div><div><h3>Conclusion</h3><div>Auxora treatment significantly reduced D-dimer levels in patients diagnosed with COVID-19, and the decrease was associated with an improved clinical status.</div></div>","PeriodicalId":34401,"journal":{"name":"Thrombosis Update","volume":"20 ","pages":"Article 100217"},"PeriodicalIF":0.0,"publicationDate":"2025-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144653782","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Characterizing anticoagulation reversal practices in Colombia: Initial insights from a national registry 哥伦比亚抗凝逆转实践的特征:来自国家登记的初步见解
Thrombosis Update Pub Date : 2025-07-01 DOI: 10.1016/j.tru.2025.100215
Sebastián Seni-Molina , Santiago Posso Marín , Juan Esteban Masmela , María Camila Naranjo-Ramírez , Arturo D. Mora , Juliana María Gutiérrez-Posso , Julio Diez-Sepúlveda , Juan David Victoria-Salcedo , Ana Cristina Montenegro Arenas , Camilo Andrés Rueda Ortiz , Edgar David Gómez Lahitton , Hoover O. León-Giraldo , Juan Esteban Gómez-Mesa , On behalf of the RECCANT-AR Research Group
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