Thrombosis and haemostasis最新文献

{"title":"Immature Platelet Fraction as an Independent Marker of Adverse Outcomes in an Intensive Cardiovascular Care Unit.","authors":"Elad Asher, Louay Taha, Mohammad Karmi, Akiva Brin, Pierre Sabouret, Mamas A Mamas, Noam Fink, Ari Naimark, Amjad Abu-Salman, Michael Glikson","doi":"10.1055/a-2944-1196","DOIUrl":"https://doi.org/10.1055/a-2944-1196","url":null,"abstract":"<p><p>Platelet activation and thrombopoiesis are central to acute cardiovascular disease pathophysiology, yet the prognostic role of the immature platelet fraction (IPF) remains incompletely defined in heterogeneous intensive cardiovascular care unit (ICCU) populations.We conducted a single-center, observational study of 6,725 consecutive ICCU admissions with IPF measured. The primary endpoint was in-hospital all-cause mortality using multivariable logistic regression, and discrimination by receiver operating characteristic analysis.Median age was 70 years; 31.8% were women. Increasing IPF quartiles showed a stepwise rise in mortality (2.1 to 3.7%; p-trend = 0.003), acute renal failure (ARF) (2.4 to 5.1%; <i>p</i> < 0.001), malignant arrhythmia (0.9 to 2.2%; <i>p</i> = 0.002), and in-hospital cardiogenic shock (2.7 to 4.7%; <i>p</i> = 0.008); the regression analysis for cardiogenic shock was restricted to incident cases among non-shock admissions (<i>n</i> = 5,778). After multivariable adjustment, each 1 natural-log-unit increment in IPF (∼1.7× raw IPF) remained independently associated with mortality (OR 1.55, 95% CI: 1.10-2.19), ARF (OR 1.75, 1.37-2.25), malignant arrhythmia (OR 2.07, 1.44-2.98), and cardiogenic shock (OR 1.51, 1.16-1.96). Discrimination of IPF alone was modest (AUC 0.57-0.59), but incorporation into multivariable models improved performance (mortality AUC 0.78). Reclassification analysis demonstrated incremental value beyond baseline (categorical net reclassification improvement [NRI] +6.9 to +12.1%; continuous NRI 0.14-0.28).In this large, contemporary ICCU cohort, elevated IPF was independently associated with in-hospital mortality, as well as adverse outcomes. Although not a standalone discriminator, IPF is a readily available, low-cost biomarker that may enhance early mortality risk stratification when integrated with established clinical variables, supporting further evaluation in multimodal and machine learning-based prediction frameworks.</p>","PeriodicalId":23036,"journal":{"name":"Thrombosis and haemostasis","volume":" ","pages":""},"PeriodicalIF":5.2,"publicationDate":"2026-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148956465","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Divergent Effects of Estradiol Regimens on Protein S and Global Coagulation in Transgender Women: A Prospective Pilot Study.","authors":"Shelly Bar-On, Merav Barzilai, Yona Greenman, Galia Spectre, Irina Shalev, Ben-Zion Katz, Esther Ziv, Karen Tordjman, Iris Yaish","doi":"10.1055/a-2945-4864","DOIUrl":"10.1055/a-2945-4864","url":null,"abstract":"<p><strong>Background: </strong>Sublingual estradiol is increasingly used for gender-affirming hormone therapy (GAHT), but its chronic hemostatic effects remain insufficiently characterized.</p><p><strong>Objectives: </strong>To compare hemostatic changes between oral estradiol plus cyproterone acetate (CPA) with divided-dose sublingual estradiol monotherapy in treatment-naive transgender women.</p><p><strong>Methods: </strong>In this prospective, non-randomized study, 30 treatment-naïve transgender women received oral estradiol 2 mg once daily plus CPA 10 mg daily (<i>n</i> = 15) or sublingual estradiol 0.5 mg four times daily without an anti-androgen (<i>n</i> = 15) for 6 months. Free protein S antigen, protein C, thrombin generation assay (TGA), and thromboelastography (TEG) were assessed at baseline and 6 months.</p><p><strong>Results: </strong>Free protein S antigen decreased in all participants receiving sublingual estradiol (median change, - 22%; <i>p</i> < 0.001), compared with a smaller, heterogeneous change with oral estradiol plus CPA (median change, - 4.2%; <i>p</i> = 0.099). At 6 months, median free protein S antigen was 77% versus 106%, respectively (<i>p</i> = 0.003). After adjustment for baseline protein S and age, sublingual treatment remained associated with lower 6-month levels (B = -15.8; <i>p</i> < 0.001). TGA lag time decreased by a median of 19% in the sublingual group, but the between-group difference was not significant after correction (adjusted <i>p</i> = 0.063). TEG maximum amplitude increased modestly with oral estradiol plus CPA and differed between groups after correction (adjusted <i>p</i> = 0.009), although values remained within physiological ranges. No thrombotic events occurred.</p><p><strong>Conclusion: </strong>The two GAHT protocols were associated with distinct laboratory hemostatic patterns, suggesting that different GAHT regimens should not be considered hemostatically equivalent. These findings warrant further evaluation in larger studies.</p>","PeriodicalId":23036,"journal":{"name":"Thrombosis and haemostasis","volume":" ","pages":""},"PeriodicalIF":5.2,"publicationDate":"2026-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148851575","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Association of Admission Immature Platelet Fraction with Long-Term Mortality Following Primary Percutaneous Coronary Intervention for STEMI.","authors":"Elad Asher, Louay Taha, Mohammad Karmi, Pierre Sabouret, Mamas A Mamas, Dan Atar, Noam Fink, Ari Naimark, Michael Glikson","doi":"10.1055/a-2945-5355","DOIUrl":"https://doi.org/10.1055/a-2945-5355","url":null,"abstract":"<p><strong>Background: </strong>Immature platelet fraction (IPF) reflects thrombopoietic activity and platelet reactivity and has been associated with adverse cardiovascular outcomes. However, its prognostic value in patients undergoing primary percutaneous coronary intervention (PPCI) for ST-elevation myocardial infarction has not been systematically evaluated.</p><p><strong>Methods: </strong>We analyzed 1,713 consecutive PPCI patients from a prospective single-center registry (July 2019-April 2026). Patients were stratified into IPF tertiles: low (≤3.0%), mid (3.0-5.1%), and high (>5.1%). The primary endpoint was long-term all-cause mortality, estimated using the Kaplan-Meier method and compared by the log-rank test. All effect estimates were derived from multivariable Cox proportional hazards regression adjusted for age, ejection fraction, sex, hypertension, diabetes mellitus, chronic renal failure, and prior coronary artery disease. Prespecified sensitivity analyses comprised a 3-year truncated analysis and a postdischarge landmark analysis.</p><p><strong>Results: </strong>Among 1,713 PPCI patients (median age: 64 years, 20.9% female), median IPF was 4.2%. Over a median potential follow-up of 3.0 years, 233 deaths (13.6%) occurred. Kaplan-Meier estimated 3-year all-cause mortality increased stepwise across tertiles: 9.1, 10.2, and 18.2% in the low, mid, and high IPF groups, respectively (log-rank <i>p</i> < 0.001). In-hospital mortality showed a nonsignificant trend (2.1, 2.6, and 3.9%; <i>p</i> = 0.157). On multivariable Cox regression, IPF as a continuous variable was not independently associated with long-term mortality (hazard ratios [HR]: 1.039 per 1% increase, 95% confidence intervals [CI]: 0.998-1.081, <i>p</i> = 0.066), whereas the high IPF tertile was independently associated with a 51% higher hazard of death compared with the low tertile (HR: 1.51, 95% CI: 1.08-2.12, <i>p</i> = 0.017). The association persisted in the 3-year truncated analysis (HR: 1.78, 95% CI: 1.23-2.58, <i>p</i> = 0.002) and in the postdischarge landmark analysis (HR: 1.52, 95% CI: 1.04-2.21, <i>p</i> = 0.03).</p><p><strong>Conclusion: </strong>High admission IPF (>5.1%) was independently associated with increased long-term mortality after PPCI. Because IPF is automatically reported as part of the admission complete blood count at no additional cost, it may help identify patients who warrant closer postdischarge surveillance. However, external validation in independent cohorts is required before IPF can be incorporated into routine risk stratification.</p>","PeriodicalId":23036,"journal":{"name":"Thrombosis and haemostasis","volume":" ","pages":""},"PeriodicalIF":5.2,"publicationDate":"2026-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148906418","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical Characteristics and Early Outcomes of Acute Pulmonary Embolism Presenting with Syncope.","authors":"Marina López-Rubio, Victor Manuel Martínez-Castilla, Andrea Cobo-Bustamante, Lorena Sanz-Tejeiro, Rubén Alonso-Beato, Lucía Ordieres-Ortega, Crhistian-Mario Oblitas, Luis Antonio Álvarez-Sala Walther, Francisco Galeano-Valle, Pablo Demelo-Rodriguez","doi":"10.1055/a-2949-8251","DOIUrl":"https://doi.org/10.1055/a-2949-8251","url":null,"abstract":"<p><strong>Background: </strong>The prognostic significance of syncope in patients with acute pulmonary embolism (PE) remains uncertain. We assessed its association with early outcomes and explored whether distinct clinical phenotypes could be identified within this group.</p><p><strong>Methods: </strong>We analyzed a prospectively collected single-center cohort of patients with confirmed symptomatic PE diagnosed between 2010 and 2025, grouped by syncope at presentation. The primary outcome was a 30-day composite of all-cause mortality, major bleeding, and recurrent venous thromboembolism. Associations were estimated using inverse probability of exposure weighting. Estimand A balanced baseline confounders, whereas Estimand B additionally balanced measured markers of acute severity. Within the syncope subgroup, exploratory clustering used 13 baseline clinical variables.</p><p><strong>Results: </strong>Among 2,331 patients with PE, 329 (14.1%) presented with syncope. Under Estimand A, syncope was associated with a 14.0-percentage-point higher risk of the composite outcome (95% confidence interval [CI]: 9.0-19.6; risk ratio [RR]: 2.71, 95% CI: 2.02-3.52). Under Estimand B, the association was substantially attenuated, with a risk difference of 5.2 percentage points (95% CI: - 0.2 to 10.6; RR: 1.54, 95% CI: 0.98-2.19). A similar attenuation was observed for all-cause mortality and major bleeding. Exploratory clustering identified four phenotypes, none of which met the prespecified criteria for internal stability.</p><p><strong>Conclusion: </strong>In acute PE, syncope identifies patients at higher risk of early adverse outcomes. This association was substantially attenuated after accounting for measured acute severity, suggesting that syncope mainly marks a more severe initial presentation rather than carrying prognostic information independent of severity.</p>","PeriodicalId":23036,"journal":{"name":"Thrombosis and haemostasis","volume":" ","pages":""},"PeriodicalIF":5.2,"publicationDate":"2026-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148906612","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Mouse Models to Study Von Willebrand Factor in Hemostasis: A Scoping Review.","authors":"Veronica DeYoung, Hassan Masood, Peter Andrisani, Arthane Kodeeswaran, Jaskirat Arora, Taylor Sparring, Natasha Savic, Jonathan L Babulic, Patricia C Liaw, Davide Matino, Alison Fox-Robichaud, Colin A Kretz","doi":"10.1055/a-2941-2718","DOIUrl":"10.1055/a-2941-2718","url":null,"abstract":"<p><strong>Background: </strong>Von Willebrand factor (VWF) and its primary molecular regulator, ADAMTS13, play an important role in hemostasis. Their dysfunction has been increasingly linked to numerous bleeding, thrombotic, and inflammatory conditions. Murine bleeding models are widely used to study their role and assess therapeutic efficacy of targeted agents. Despite this, no review has systematically identified and compared bleeding models proven to involve VWF or ADAMTS13 in vivo. This scoping review addresses this gap by identifying models, associated outcomes, and evaluating methodological inconsistencies that may impact translatability.</p><p><strong>Methods: </strong>A comprehensive literature search was conducted to identify studies using murine models of hemostasis from inception to October 2024. Two reviewers independently screened articles and extracted data on mouse characteristics, bleeding induction methods, and VWF or ADAMTS13-related findings.</p><p><strong>Results: </strong>A total of 35 studies published between 1997 and 2024 were included; 40.0% utilized C57BL/6J mice and 40.0% of models used both sexes. Fourteen (40.0%) studies did not report the mouse supplier, and 20.0 and 80.0% did not report the age and weight of mice, respectively. Most studies (91.4%) used the tail tip transection model, 5.7% employed saphenous vein bleed, and 5.7% performed tail vein transection. Key methodological variations pertained to bleeding quantification, maximum observation time, and length of tail tip removed.</p><p><strong>Conclusion: </strong>This review highlights that most studies assessing VWF-related hemostasis use a single model, but there is methodological variability, limiting reproducibility and translational relevance. Standardized protocols and collaborative efforts to establish consensus guidelines are urgently needed to improve cross-study comparisons to strengthen preclinical therapeutic testing.</p>","PeriodicalId":23036,"journal":{"name":"Thrombosis and haemostasis","volume":" ","pages":""},"PeriodicalIF":5.2,"publicationDate":"2026-09-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148798131","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Recent Trials of Left Atrial Appendage Closure versus Oral Anticoagulants: An Optimistic View.","authors":"A John Camm","doi":"10.1055/a-2945-5484","DOIUrl":"https://doi.org/10.1055/a-2945-5484","url":null,"abstract":"<p><strong>Abstract: </strong>Thrombus formation in atrial fibrillation mostly occurs in the left atrial appendage (LAA). LAA closure (LAAC) seems logical to reduce thrombo-embolic AF-related stroke. Early device trials, which predominantly compared LAAC against oral anticoagulant (OAC) with warfarin, showing after 5 years less bleeding and possibly similar ischemic stroke rates with LAAC. New trials (CHAMPION-AF, OPTION, CLUSTER-AF and ASAP TOO) comparing LAAC versus direct OACs, or standard of care for the OAC-intolerant, have reported apparently discordant results, most probably related to the patient phenotype than LAAC itself. Recent meta-analyses, which include new trials have shown that overall, LAAC is followed by less clinically-relevant bleeding but more ischemic but not total strokes. Longer follow-up offsetting penalties related to the implant procedure, more expert implantation and reduced device-related thrombosis should increase the comparative value of LAAC. Meanwhile, LAAC offers therapeutic relief for OAC-intolerant patients or for those wh, understand the outcomes of LAAC and prefer device rather than medical therapy. A change in guideline recommendations should now be considered.</p>","PeriodicalId":23036,"journal":{"name":"Thrombosis and haemostasis","volume":" ","pages":""},"PeriodicalIF":5.2,"publicationDate":"2026-09-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148901181","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Blood Levels and Composition of Leukocyte-Platelet Aggregates in Inflammatory Diseases of Various Etiologies.","authors":"Alina D Peshkova, Shakhnoza M Saliakhutdinova, Khetam Sounbuli, Izabella A Andrianova, Rustem I Litvinov, John W Weisel","doi":"10.1055/a-2742-3449","DOIUrl":"10.1055/a-2742-3449","url":null,"abstract":"<p><strong>Background: </strong>Leukocyte-platelet aggregates (LPAs) play a crucial role in the pathogenesis of inflammatory diseases, linking pathological immune responses with thrombosis.</p><p><strong>Material and methods: </strong>The levels of LPAs, their composition, and cellular reactivity were determined in patients with distinct inflammatory conditions, namely coronavirus disease 2019 (COVID-19), rheumatoid arthritis (RA), and systemic lupus erythematosus (SLE), compared with healthy controls. Flow cytometry was used to identify cell types and measure LPA levels in the blood. The ability of platelets, neutrophils, and monocytes to form additional LPAs in response to hyperstimulation with phorbol-12-myristate-13-acetate (PMA) was assessed. Coaggregation of isolated neutrophils and platelets in vitro was visualized using scanning electron microscopy. Blood tests included coagulation, hematology, biochemistry, and immunology.</p><p><strong>Results: </strong>LPA levels were significantly higher in all patient groups compared with controls, with variations in the composition: neutrophil-platelet aggregates predominated in the COVID-19 patients, whereas monocyte-platelet aggregates prevailed in the blood of RA and SLE patients. Platelet-to-leukocyte ratios within aggregates varied in a broad range with a substantial prevalence of platelets over leukocytes. Morphological analysis revealed coaggregation of platelets with neutrophils, including relatively large homotypic platelet aggregates associated with one or two neutrophils. In PMA-treated pathological blood samples from COVID-19, RA, and SLE patients, the ability to form additional LPAs over the patients' baseline level was reduced compared with normal blood samples, indicating impaired reactivity (exhaustion) of neutrophils and monocytes in all patient groups.</p><p><strong>Conclusion: </strong>This study highlights distinct changes in the number and composition of LPAs in inflammatory diseases of various etiologies associated with altered functionality of the innate immune cells.</p>","PeriodicalId":23036,"journal":{"name":"Thrombosis and haemostasis","volume":" ","pages":"948-961"},"PeriodicalIF":5.2,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145506716","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Venous Thromboembolism and Vascular Access Thrombosis in Patients on Hemodialysis: Incidence, Risk Factors, and Use of Antithrombotic Agents.","authors":"Oliver Königsbrügge, Renate Klauser-Braun, Sabine Schmaldienst, Matthias Lorenz, Ingrid Pabinger, Marcus Säemann, Cihan Ay","doi":"10.1055/a-2700-6368","DOIUrl":"10.1055/a-2700-6368","url":null,"abstract":"<p><strong>Background: </strong>Patients with end-stage kidney disease on hemodialysis (HD) have an increased risk of venous thromboembolism (VTE) and HD-specific vascular access thrombosis (VAT). We aimed to capture the incidence of VTE and VAT events and investigate risk factors for VTE and VAT occurrence, including antithrombotic agent use.</p><p><strong>Methods: </strong>Prevalent patients on maintenance HD were recruited into a prospective, population-based, observational cohort study in Vienna, Austria. During a maximum follow-up of 45 months, the occurrence of VTE, defined as deep vein thrombosis, catheter- or noncatheter-associated, and pulmonary embolism, or VAT, defined as thrombotic occlusion of an arteriovenous fistula or graft, was recorded. Risk factors for thrombotic events were analyzed by multivariable competing risk regression.</p><p><strong>Results: </strong>VTE and VAT events occurred with an incidence rate of 1.7 (95% confidence interval [CI]: 1.2-2.6) and 7.6 per 100 person-years (95% CI: 6.3-9.3), respectively. The 30-day case fatality rates were 20.8 and 4.1% for VTE and VAT events, respectively. Prior VAT (hazard ratio [HR]: 3.07, 95% CI: 1.33-7.11, <i>p</i> = 0.009) and nephrectomy (HR: 6.53, 95% CI: 2.23-19.14, <i>p</i> = 0.001) were significantly associated with increased risk of VTE occurrence. Prior VAT was associated with a 1.8-fold (95% CI: 1.18-2.65, <i>p</i> = 0.006) and nephrectomy with a 2.8-fold increased risk of VAT occurrence (95% CI: 1.45-5.57, <i>p</i> = 0.002). Patients on vitamin K antagonists were protected from VTE (HR: 0.001, 95% CI: <0.01- < 0.01, <i>p</i> < 0.001) compared with nonusers but had no benefit with regard to VAT events.</p><p><strong>Conclusion: </strong>Identifying patients at high risk of thrombotic complications using risk factors, such as a history of nephrectomy and prior thrombotic events, may facilitate preventive measures.</p>","PeriodicalId":23036,"journal":{"name":"Thrombosis and haemostasis","volume":" ","pages":"965-973"},"PeriodicalIF":5.2,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145138623","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Heavy Menstrual Bleeding in Women Treated with Direct Oral Anticoagulants: Results of the Prospective HEMBLED Registry.","authors":"Edelgard Lindhoff-Last, Inka Wiegratz, Olivia Ott, Yvonne Weil, Christoph Sucker, Susan Halimeh, Holger Seidel, Christian Schambeck, Konstantin Kirchmayr, Eva Herrmann","doi":"10.1055/a-2724-4458","DOIUrl":"10.1055/a-2724-4458","url":null,"abstract":"<p><strong>Background: </strong>Heavy menstrual bleeding (HMB) is a common complication of anticoagulant therapy in menstruating women with venous thromboembolism (VTE). Direct oral anticoagulants (DOAC) used for VTE treatment may differ in their menstrual bleeding profiles. Therefore, the prospective multicenter noninterventional investigator-initiated HEMBLED registry (HE: avy M: enstrual BLE: eding in patients treated with D: OAC) was performed to analyze spontaneous menstrual bleeding in women treated with therapeutic DOAC doses.</p><p><strong>Methods: </strong>A modified pictorial blood assessment chart (PBAC) score was used to define the severity of menstrual bleeding. Patients were only included when they did not use hormonal or intrauterine contraception methods. The prospective follow-up was 4 months. The primary endpoint was the comparison of the PBAC scores between the individual DOAC groups.</p><p><strong>Results: </strong>Overall, 73 patients with 213 monthly assessments of the PBAC scores were analyzed. Patients were on average 35 years old and were anticoagulated with apixaban (62%), rivaroxaban (26%), edoxaban (7%), or dabigatran (6%). The PBAC scores of the rivaroxaban group (mean: 145 points) were significantly increased by 54% compared with the apixaban group (mean: 93 points, <i>p</i> = 0.0193). HMB (PBAC score > 100 points) at least once was detected in 53% of the apixaban group compared with 79% of the rivaroxaban group (<i>p</i> = 0.0913). The duration of menstrual bleeding was numerically shorter in the apixaban group compared with the rivaroxaban group (<i>p</i> = 0.1894).</p><p><strong>Conclusion: </strong>DOAC differ in their influence on the intensity of spontaneous menstrual bleeding. This should be taken into account when advising young women with VTE who need an oral anticoagulant.</p>","PeriodicalId":23036,"journal":{"name":"Thrombosis and haemostasis","volume":" ","pages":"974-982"},"PeriodicalIF":5.2,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13521661/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145507046","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pharmacokinetics, Hemostatic Efficacy, and Safety of a New Human Fibrinogen Concentrate in Adult and Pediatric Patients with Congenital Fibrinogen Deficiency.","authors":"Claudia Djambas Khayat, Amal El-Beshlawy, Balkis Meddeb, Abderrahim Khelif, Wolfgang Miesbach, Sonia Adolf, Heike Boehm, Silke Aigner, Salomon Abraha, Fabian Bohlaender, Joerg Schuettrumpf","doi":"10.1055/a-2715-2994","DOIUrl":"10.1055/a-2715-2994","url":null,"abstract":"<p><p>Congenital fibrinogen deficiencies are rare coagulopathies which are treated by fibrinogen concentrates. This trial investigated the pharmacokinetic/pharmacodynamic (PK/PD) parameters, and surrogate efficacy and safety of a new human fibrinogen concentrate (HFC), BT524, in patients with congenital afibrinogenemia or severe hypofibrinogenemia.This prospective, multi-national, open-label, single-arm PK/PD trial evaluated PK/PD parameters of HFC (part 1; phase I) and HFC as on-demand treatment or prophylaxis for bleeding events (part 2; phase III). In part 1, patients received a single-dose of HFC (70 mg/kg body weight [BW]). PK/PD parameters were calculated using a PK/PD model and non-compartmental analysis. Fibrinogen antigen (FiAg) levels were determined over 14 days by immunonephelometry and fibrinogen activity (FiAc) by Clauss assay. The efficacy variable was mean change in maximum clot firmness (MCF) analyzed by thromboelastometry. Safety parameters were evaluated for 49 days.A total of 27 patients (<i>n</i> = 15 adults, <i>n</i> = 12 children) were treated with HFC. For FiAg, mean (SD) PK parameters were: C_max 1.81 (0.42) g/L, AUC_0-∞ 173 (45.4) g*h/L, and t_1/2 67.9 (15.3) h. For FiAc, they were C_max 1.26 (0.4) g/L, AUC_0-∞ 104 (33.5) g*h/L, and t_1/2 60.3 (13.3) h. In adults, MCF significantly increased 1 h after HFC infusion (11.1 (5.1) mm; <i>P</i> < 0.0001; 95% CI: 9.33-14.47). In pediatrics, mean increase in range was 9.3 to 16.5 mm. Treatment-related adverse events were rare, with one mild increase in fibrin D-dimer. No thromboembolic events, hypersensitivity, or allergic reactions were observed.HFC effectively increased FiAg levels and FiAc, improved clot firmness, and showed a favorable safety and tolerability profile in adult and pediatric patients with congenital fibrinogen deficiency.</p>","PeriodicalId":23036,"journal":{"name":"Thrombosis and haemostasis","volume":" ","pages":"919-929"},"PeriodicalIF":5.2,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13521662/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145313816","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}