Pub Date : 2026-01-06DOI: 10.1016/j.thromres.2025.109580
Maria Chovi-Trull , Juan Eduardo Megías-Vericat , Tomás Palanques-Pastor , Ana Cid Haro , Manuel Rodriguez López , Antonio Palomero Massanet , Shally Marcellini Antonio , Saturnino Haya Guaita , Javier García Pellicer , Jose Luis Poveda Andrés , Santiago Bonanad Boix
Introduction
Extended half-life factor IX concentrates (FIX-EHL) have been shown to improve clinical outcomes and reduce treatment burden in patients with hemophilia B (HB).
Objectives
To analyze the differences in pharmacokinetic (PK) and clinical parameters one year before and after the PK-guided switch from standard half-life FIX (FIX-SHL) to FIX-EHL in patients with severe/moderate HB on prophylaxis.
Methods
A multicenter, comparative, observational, sequential, retrospective, and multidisciplinary study was conducted. PK parameters were calculated with WAPPS-Hemo®, and annualized total (ABR) and joint bleeding rates, the t1/2 ratio and area under the curve (AUC), FIX consumption, infusion frequency, and cost were recorded.
Results
A total of 21 patients (9 pediatric and 12 adult) with HB who switched from FIX-SHL to FIX-EHL were analyzed. All PK parameters improved significantly, with median improvement ratios for t1/2 and AUC of 4.1 (IQR: 3.4–4.8) and 4.2 (IQR: 2.6–5.0), respectively. Regarding clinical outcomes, the difference in ABR reached statistical significance and among the 6 patients with target joints, 5 (83.3 %) achieved resolution after switching. Infusion frequency and weekly dose were reduced by 50.0 % and 56.3 %, respectively, avoiding 52.1 (IQR: 26.1–67.8) injections and 130,357.3 (IQR: 5142.9–203,357.3) IU of FIX per patient per year. However, the switch resulted in an additional cost of € 28,254.9 (IQR: 4432.1- 44,060.8) per patient per year.
Conclusions
The PK-guided switch from FIX-SHL to FIX-EHL was associated with improvements in all PK parameters, and a significant clinical benefit was also demonstrated with the reduction of the bleeding rates. Following the switch, the weekly dose and administration frequency were reduced; however, this did not result in a cost reduction.
{"title":"Improvements in pharmacokinetics, bleeding control, and cost analysis after PK-guided transition to extended-half-life factor IX in hemophilia B: A multicentric study","authors":"Maria Chovi-Trull , Juan Eduardo Megías-Vericat , Tomás Palanques-Pastor , Ana Cid Haro , Manuel Rodriguez López , Antonio Palomero Massanet , Shally Marcellini Antonio , Saturnino Haya Guaita , Javier García Pellicer , Jose Luis Poveda Andrés , Santiago Bonanad Boix","doi":"10.1016/j.thromres.2025.109580","DOIUrl":"10.1016/j.thromres.2025.109580","url":null,"abstract":"<div><h3>Introduction</h3><div>Extended half-life factor IX concentrates (FIX-EHL) have been shown to improve clinical outcomes and reduce treatment burden in patients with hemophilia B (HB).</div></div><div><h3>Objectives</h3><div>To analyze the differences in pharmacokinetic (PK) and clinical parameters one year before and after the PK-guided switch from standard half-life FIX (FIX-SHL) to FIX-EHL in patients with severe/moderate HB on prophylaxis.</div></div><div><h3>Methods</h3><div>A multicenter, comparative, observational, sequential, retrospective, and multidisciplinary study was conducted. PK parameters were calculated with WAPPS-Hemo®, and annualized total (ABR) and joint bleeding rates, the t<sub>1/2</sub> ratio and area under the curve (AUC), FIX consumption, infusion frequency, and cost were recorded.</div></div><div><h3>Results</h3><div>A total of 21 patients (9 pediatric and 12 adult) with HB who switched from FIX-SHL to FIX-EHL were analyzed. All PK parameters improved significantly, with median improvement ratios for t<sub>1/2</sub> and AUC of 4.1 (IQR: 3.4–4.8) and 4.2 (IQR: 2.6–5.0), respectively. Regarding clinical outcomes, the difference in ABR reached statistical significance and among the 6 patients with target joints, 5 (83.3 %) achieved resolution after switching. Infusion frequency and weekly dose were reduced by 50.0 % and 56.3 %, respectively, avoiding 52.1 (IQR: 26.1–67.8) injections and 130,357.3 (IQR: 5142.9–203,357.3) IU of FIX per patient per year. However, the switch resulted in an additional cost of € 28,254.9 (IQR: 4432.1- 44,060.8) per patient per year.</div></div><div><h3>Conclusions</h3><div>The PK-guided switch from FIX-SHL to FIX-EHL was associated with improvements in all PK parameters, and a significant clinical benefit was also demonstrated with the reduction of the bleeding rates. Following the switch, the weekly dose and administration frequency were reduced; however, this did not result in a cost reduction.</div></div>","PeriodicalId":23064,"journal":{"name":"Thrombosis research","volume":"258 ","pages":"Article 109580"},"PeriodicalIF":3.4,"publicationDate":"2026-01-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145967192","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-02DOI: 10.1016/j.thromres.2025.109581
Alexander Schmidt , Joschua Wiese , Fabian Tomschi , Barabara Boddenberg-Pätzold , Andreas Christian Strauss , Thomas Hilberg
Purpose
This systematic-review and meta-analysis investigated the effectiveness of radiosynoviorthesis (RSO) on clinical outcomes in male persons with haemophilia (PwH) and evaluated the quality of existing evidence.
Methods
Literature searches in PubMed and Web of Science identified 31 studies, with 17 included in the meta-analysis. Random-effects models were computed to analyse RSO-related changes in bleeding frequency, pain, synovial hypertrophy, and orthopaedic joint score. Due to insufficient data, Range of Motion (RoM) changes could not be meta-analytically calculated. Mean differences (MD) for bleeding frequency and standardized mean differences (SMD) for the remaining outcomes were computed.
Results
Results showed significant reductions in bleeding frequency at six months (MD = −5.93 [95 %-CI: −7.80, −4.06], p < 0.001, k = 10) and twelve months (MD = −7.83 [95 %-CI: −12.11, −3.55], p < 0.001, k = 6). Six months post treatment, pain (SMD = −1.31 [95 %-CI: −2.25, −0.38], p = 0.006, k = 5), synovial hypertrophy (SMD = −0.50 [95 %-CI: −0.65, −0.36], p < 0.001, k = 4), and orthopaedic joint score (SMD = −0.61 [95 %-CI: −0.92, −0.30], p < 0.001, k = 4) showed moderate to large improvements. Average RoM changes were minimal (2.6 % improvement). The overall complication rate was 12 per 1000 treated joints.
Conclusion
Despite promising results, the overall quality of evidence was moderate to low due to high methodological heterogeneity and lack of control groups. These findings suggest RSO is a safe and effective treatment for key clinical outcomes in PwH, but further well-designed controlled trials are needed to confirm these results.
目的:本系统综述和荟萃分析探讨了放射滑膜术(RSO)对男性血友病(PwH)患者临床结果的有效性,并评估了现有证据的质量。方法在PubMed和Web of Science中检索了31项研究,其中17项纳入了meta分析。计算随机效应模型来分析与rso相关的出血频率、疼痛、滑膜肥厚和骨科关节评分的变化。由于数据不足,活动度(RoM)的变化不能进行meta分析计算。计算出血频率的平均差异(MD)和其余结果的标准化平均差异(SMD)。结果6个月时(MD = - 5.93 [95% -CI: - 7.80, - 4.06], p < 0.001, k = 10)和12个月时(MD = - 7.83 [95% -CI: - 12.11, - 3.55], p < 0.001, k = 6)出血频率显著降低。治疗6个月后,疼痛(SMD = - 1.31 [95% -CI: - 2.25, - 0.38], p = 0.006, k = 5)、滑膜肥厚(SMD = - 0.50 [95% -CI: - 0.65, - 0.36], p < 0.001, k = 4)和矫形关节评分(SMD = - 0.61 [95% -CI: - 0.92, - 0.30], p < 0.001, k = 4)均有中度至重度改善。平均RoM变化最小(改善2.6%)。总并发症发生率为12 / 1000。结论尽管结果令人鼓舞,但由于方法学的高度异质性和缺乏对照组,证据的总体质量为中到低。这些发现表明,对于PwH的关键临床结果,RSO是一种安全有效的治疗方法,但需要进一步精心设计的对照试验来证实这些结果。
{"title":"Efficacy of radiosynoviorthesis on clinical outcomes in persons with haemophilia. A systematic review and meta-analysis","authors":"Alexander Schmidt , Joschua Wiese , Fabian Tomschi , Barabara Boddenberg-Pätzold , Andreas Christian Strauss , Thomas Hilberg","doi":"10.1016/j.thromres.2025.109581","DOIUrl":"10.1016/j.thromres.2025.109581","url":null,"abstract":"<div><h3>Purpose</h3><div>This systematic-review and meta-analysis investigated the effectiveness of radiosynoviorthesis (RSO) on clinical outcomes in male persons with haemophilia (PwH) and evaluated the quality of existing evidence.</div></div><div><h3>Methods</h3><div>Literature searches in PubMed and Web of Science identified 31 studies, with 17 included in the meta-analysis. Random-effects models were computed to analyse RSO-related changes in bleeding frequency, pain, synovial hypertrophy, and orthopaedic joint score. Due to insufficient data, Range of Motion (RoM) changes could not be meta-analytically calculated. Mean differences (MD) for bleeding frequency and standardized mean differences (SMD) for the remaining outcomes were computed.</div></div><div><h3>Results</h3><div>Results showed significant reductions in bleeding frequency at six months (MD = −5.93 [95 %-CI: −7.80, −4.06], <em>p</em> < 0.001, k = 10) and twelve months (MD = −7.83 [95 %-CI: −12.11, −3.55], p < 0.001, k = 6). Six months post treatment, pain (SMD = −1.31 [95 %-CI: −2.25, −0.38], <em>p</em> = 0.006, k = 5), synovial hypertrophy (SMD = −0.50 [95 %-CI: −0.65, −0.36], <em>p</em> < 0.001, k = 4), and orthopaedic joint score (SMD = −0.61 [95 %-CI: −0.92, −0.30], p < 0.001, k = 4) showed moderate to large improvements. Average RoM changes were minimal (2.6 % improvement). The overall complication rate was 12 per 1000 treated joints.</div></div><div><h3>Conclusion</h3><div>Despite promising results, the overall quality of evidence was moderate to low due to high methodological heterogeneity and lack of control groups. These findings suggest RSO is a safe and effective treatment for key clinical outcomes in PwH, but further well-designed controlled trials are needed to confirm these results.</div></div>","PeriodicalId":23064,"journal":{"name":"Thrombosis research","volume":"258 ","pages":"Article 109581"},"PeriodicalIF":3.4,"publicationDate":"2026-01-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145927718","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-02DOI: 10.1016/j.thromres.2025.109573
For the DELPHI Serenity Group, Isabelle Mahé , Skerdi Haviari , Nassima Si Mohammed , Anette Arbjerg Højen , Carme Font , Stavros Konstantinides , Marieke J.H.A. Kruip , Luigi Maiorana , Sebastian Szmit , Denise Abbel , Laurent Bertoletti , Adrian Edwards , Michelle Edwards , Alessandra Gava , Jacobijn Gussekloo , Miriam J. Johnson , Rashmi Kumar , Johan Langendoen , Kate J. Lifford , Camille Couffignal
Introduction
To develop a European shared decision-support tool (SDST), a two-round Delphi process was used to achieve consensus on aspects relating to the antithrombotic therapy (ATT) deprescribing discussions and process in end-of-life cancer patients.
Methods
Conducted between September 2024 and March 2025, the Delphi survey was developed by a multidisciplinary 24-member steering committee (SC), including medical specialists in oncology, hematology, palliative care, primary care, geriatrics, and vascular medicine. The survey involved 188 experts from these specialties across eight European countries. Consensus was defined with pooled items as ≥70 % agreement with a final decision by the SC. Themes covered deprescribing timing, stakeholders, reassessment and clinical drivers of patients with ATT, SDST, and choice of outcomes for a randomized controlled trial (RCT) to evaluate the SDST.
Results
Round 1 reached consensus for seven pooled questions (37 %), especially the reassessment of ATT deprescribing. Considering these results, the SC reformulated round 2 to reduce ambiguity and move toward consensus. The SC made the final decision. Three medical specialties should be involved in ATT deprescribing: palliative care specialists, oncologists, and general practitioners after a triggering circumstance such as clinical triggers or at 3-month prognosis. For the SDST design, the findings confirmed that this tool would be meaningful to clinicians. Eleven predefined outcomes were selected for a future RCT.
Conclusion
These results succeeded in shaping the content of the future SDST and mapping its useability in palliative care clinical pathways across Europe, with the perspective to support informed decision-making, reduce complications, and improve quality of life in this population.
{"title":"Developing a decision support tool for the continuation or deprescribing of antithrombotic therapy in patients receiving end-of-life care: Results of a European Delphi study","authors":"For the DELPHI Serenity Group, Isabelle Mahé , Skerdi Haviari , Nassima Si Mohammed , Anette Arbjerg Højen , Carme Font , Stavros Konstantinides , Marieke J.H.A. Kruip , Luigi Maiorana , Sebastian Szmit , Denise Abbel , Laurent Bertoletti , Adrian Edwards , Michelle Edwards , Alessandra Gava , Jacobijn Gussekloo , Miriam J. Johnson , Rashmi Kumar , Johan Langendoen , Kate J. Lifford , Camille Couffignal","doi":"10.1016/j.thromres.2025.109573","DOIUrl":"10.1016/j.thromres.2025.109573","url":null,"abstract":"<div><h3>Introduction</h3><div>To develop a European shared decision-support tool (SDST), a two-round Delphi process was used to achieve consensus on aspects relating to the antithrombotic therapy (ATT) deprescribing discussions and process in end-of-life cancer patients.</div></div><div><h3>Methods</h3><div>Conducted between September 2024 and March 2025, the Delphi survey was developed by a multidisciplinary 24-member steering committee (SC), including medical specialists in oncology, hematology, palliative care, primary care, geriatrics, and vascular medicine. The survey involved 188 experts from these specialties across eight European countries. Consensus was defined with pooled items as ≥70 % agreement with a final decision by the SC. Themes covered deprescribing timing, stakeholders, reassessment and clinical drivers of patients with ATT, SDST, and choice of outcomes for a randomized controlled trial (RCT) to evaluate the SDST.</div></div><div><h3>Results</h3><div>Round 1 reached consensus for seven pooled questions (37 %), especially the reassessment of ATT deprescribing. Considering these results, the SC reformulated round 2 to reduce ambiguity and move toward consensus. The SC made the final decision. Three medical specialties should be involved in ATT deprescribing: palliative care specialists, oncologists, and general practitioners after a triggering circumstance such as clinical triggers or at 3-month prognosis. For the SDST design, the findings confirmed that this tool would be meaningful to clinicians. Eleven predefined outcomes were selected for a future RCT.</div></div><div><h3>Conclusion</h3><div>These results succeeded in shaping the content of the future SDST and mapping its useability in palliative care clinical pathways across Europe, with the perspective to support informed decision-making, reduce complications, and improve quality of life in this population.</div></div>","PeriodicalId":23064,"journal":{"name":"Thrombosis research","volume":"258 ","pages":"Article 109573"},"PeriodicalIF":3.4,"publicationDate":"2026-01-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145977994","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-29DOI: 10.1016/j.thromres.2025.109572
Xiaoling Shui , Yuqiong Cao , Yuhong He , Shan Zeng , Na Ye , Mao Ma
Background
Thrombosis, encompassing both venous thromboembolism (VTE) and arterial thrombotic events, represents a leading cause of mortality in patients with Systemic Lupus Erythematosus (SLE). A comprehensive evaluation of risk factors specific to each thrombotic type remains lacking.
Objective
To systematically identify and compare risk factors for venous and arterial thrombosis in SLE patients through a meta-analysis.
Methods
We systematically searched PubMed, Web of Science, Embase, Cochrane Library, CNKI, and Wanfang Data from inception to August 2025. Cohort studies (prospective or retrospective) and case-control studies reporting multivariable-adjusted associations between risk factors and thrombotic events in SLE were included. Two researchers independently performed study selection, data extraction, and quality assessment using the Newcastle-Ottawa Scale. Pooled odds ratios (ORs) with 95 % confidence intervals (CIs) were calculated using random-effects models.
Results
Analysis of 25 studies (13,290 patients) identified distinct risk factor profiles. For venous thrombosis, lupus anticoagulant showed the strongest association (OR 6.17, 95 % CI 2.77–13.76), followed by anti-β2-glycoprotein I IgA (OR 4.77, 95 % CI 3.08–7.39). Antiphospholipid syndrome demonstrated an exceptionally high risk (OR 44.72, 95 % CI 9.93–201.34). Elevated D-dimer was a specific venous thrombosis predictor (OR 1.35, 95 % CI 1.22–1.49). For arterial thrombosis, traditional cardiovascular risk factors predominated, including hypertension (OR 3.39, 95 % CI 2.38–4.83) and obesity (OR 3.17, 95 % CI 1.50–6.66). Disease-related factors such as high SLEDAI scores (OR 1.11, 95 % CI 1.05–1.16) and renal insufficiency (OR 2.38, 95 % CI 1.42–4.00) were associated with increased thrombotic risk.
Conclusion
Thrombosis in SLE exhibits distinct risk factor patterns between venous and arterial events. Venous thrombosis is strongly driven by antiphospholipid antibodies, while arterial events are predominantly associated with traditional cardiovascular risk factors. This review identifies and distinguishes key risk factors for venous and arterial thrombosis in SLE. These findings highlight the necessity for thrombotic type-specific risk assessment and provide an evidence base to inform the future development of targeted preventive strategies.
背景:血栓形成,包括静脉血栓栓塞(VTE)和动脉血栓事件,是系统性红斑狼疮(SLE)患者死亡的主要原因。对每种血栓形成类型的危险因素的综合评估仍然缺乏。目的:通过荟萃分析系统地识别和比较SLE患者静脉和动脉血栓形成的危险因素。方法:系统检索PubMed、Web of Science、Embase、Cochrane Library、CNKI、万方数据,检索时间为建站至2025年8月。队列研究(前瞻性或回顾性)和病例对照研究报告了SLE中危险因素与血栓形成事件之间的多变量调整相关性。两名研究人员使用纽卡斯尔-渥太华量表独立进行研究选择、数据提取和质量评估。采用随机效应模型计算95%置信区间(ci)的合并优势比(ORs)。结果:对25项研究(13290例患者)的分析确定了不同的风险因素。对于静脉血栓形成,狼疮抗凝剂的相关性最强(OR 6.17, 95% CI 2.77 ~ 13.76),其次是抗β2-糖蛋白I IgA (OR 4.77, 95% CI 3.08 ~ 7.39)。抗磷脂综合征表现出异常高的风险(OR 44.72, 95% CI 9.93-201.34)。升高的d -二聚体是特定的静脉血栓形成预测因子(OR 1.35, 95% CI 1.22-1.49)。对于动脉血栓,传统的心血管危险因素占主导地位,包括高血压(OR 3.39, 95% CI 2.38-4.83)和肥胖(OR 3.17, 95% CI 1.50-6.66)。疾病相关因素,如高SLEDAI评分(OR 1.11, 95% CI 1.05-1.16)和肾功能不全(OR 2.38, 95% CI 1.42-4.00)与血栓形成风险增加相关。结论:SLE血栓形成在静脉和动脉事件之间表现出不同的危险因素模式。静脉血栓形成是由抗磷脂抗体强烈驱动的,而动脉事件主要与传统的心血管危险因素相关。这篇综述确定并区分了SLE中静脉和动脉血栓形成的关键危险因素。这些发现强调了血栓形成特定类型风险评估的必要性,并为未来制定有针对性的预防策略提供了证据基础。
{"title":"Factors associated with venous and arterial thrombosis in patients with Systemic Lupus Erythematosus: A systematic review and meta-analysis","authors":"Xiaoling Shui , Yuqiong Cao , Yuhong He , Shan Zeng , Na Ye , Mao Ma","doi":"10.1016/j.thromres.2025.109572","DOIUrl":"10.1016/j.thromres.2025.109572","url":null,"abstract":"<div><h3>Background</h3><div>Thrombosis, encompassing both venous thromboembolism (VTE) and arterial thrombotic events, represents a leading cause of mortality in patients with Systemic Lupus Erythematosus (SLE). A comprehensive evaluation of risk factors specific to each thrombotic type remains lacking.</div></div><div><h3>Objective</h3><div>To systematically identify and compare risk factors for venous and arterial thrombosis in SLE patients through a meta-analysis.</div></div><div><h3>Methods</h3><div>We systematically searched PubMed, Web of Science, Embase, Cochrane Library, CNKI, and Wanfang Data from inception to August 2025. Cohort studies (prospective or retrospective) and case-control studies reporting multivariable-adjusted associations between risk factors and thrombotic events in SLE were included. Two researchers independently performed study selection, data extraction, and quality assessment using the Newcastle-Ottawa Scale. Pooled odds ratios (ORs) with 95 % confidence intervals (CIs) were calculated using random-effects models.</div></div><div><h3>Results</h3><div>Analysis of 25 studies (13,290 patients) identified distinct risk factor profiles. For venous thrombosis, lupus anticoagulant showed the strongest association (OR 6.17, 95 % CI 2.77–13.76), followed by anti-β2-glycoprotein I IgA (OR 4.77, 95 % CI 3.08–7.39). Antiphospholipid syndrome demonstrated an exceptionally high risk (OR 44.72, 95 % CI 9.93–201.34). Elevated D-dimer was a specific venous thrombosis predictor (OR 1.35, 95 % CI 1.22–1.49). For arterial thrombosis, traditional cardiovascular risk factors predominated, including hypertension (OR 3.39, 95 % CI 2.38–4.83) and obesity (OR 3.17, 95 % CI 1.50–6.66). Disease-related factors such as high SLEDAI scores (OR 1.11, 95 % CI 1.05–1.16) and renal insufficiency (OR 2.38, 95 % CI 1.42–4.00) were associated with increased thrombotic risk.</div></div><div><h3>Conclusion</h3><div>Thrombosis in SLE exhibits distinct risk factor patterns between venous and arterial events. Venous thrombosis is strongly driven by antiphospholipid antibodies, while arterial events are predominantly associated with traditional cardiovascular risk factors. This review identifies and distinguishes key risk factors for venous and arterial thrombosis in SLE. These findings highlight the necessity for thrombotic type-specific risk assessment and provide an evidence base to inform the future development of targeted preventive strategies.</div></div>","PeriodicalId":23064,"journal":{"name":"Thrombosis research","volume":"258 ","pages":"Article 109572"},"PeriodicalIF":3.4,"publicationDate":"2025-12-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145864789","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-22DOI: 10.1016/j.thromres.2025.109570
Robert D. McBane II , Jennifer Lutz , Carlee O'Connor , Anna Kramer , Michael Luker , David Hodge , Colleen S. Thomas , Harold J. Hellweg
Objective
Systems employing point-of-care (POC) INR monitoring with patient self-testing require test accuracy, data integrity, patient compliance, and prompt two-way communication for high quality warfarin management. With a goal of validating a POC Bluetooth capable device for prompt INR transfer to electronic medical record, two POC INR devices were compared against an internal plasma INR reference.
Methods
A multicenter study (February 14, 2023 – August 29, 2023) comparing concordance of two commercially available POC devices, Vantus and CoaguChek XS (Pro and Plus), against a plasma INR reference, was pursued among warfarin treated patients. Appropriateness of dosing decisions were assessed for each device.
Results
Across three Mayo Clinic sites, 151 warfarin treated patients agreed to participate. Atrial fibrillation (41.7 %), venous thromboembolism (33.1 %) and heart valve prosthesis (19.9 %) were common indications with target INR range 2.0–3.0 in 89 %. For the CoaguChek devices, 86.1 % of values fell within 0.4 INR units compared with plasma INR referent (CoaguChek - plasma INR correlation R2 = 0.95). For the Vantus device, 88.7 % of values fell within 0.4 INR units of plasma INR values (Vantus – plasma INR correlation R2 = 0.96). Mean (± standard deviation) deviation from plasma INR was 0.2 ± 0.3 for CoaguChek compared to 0.1 ± 0.2 for Vantus (p < 0.001). Using the plasma INR as the gold standard for dosing recommendations, appropriate dosing recommendations were similar between devices: CoaguChek 83.4 % vs Vantus 82.7 %.
Conclusions
Compared to a plasma referent, INR values obtained from the CoaguChek and Vantus devices exhibited strong correlation with plasma INR values without systemic bias.
{"title":"Bluetooth enabled point-of-care INR device validation for warfarin management","authors":"Robert D. McBane II , Jennifer Lutz , Carlee O'Connor , Anna Kramer , Michael Luker , David Hodge , Colleen S. Thomas , Harold J. Hellweg","doi":"10.1016/j.thromres.2025.109570","DOIUrl":"10.1016/j.thromres.2025.109570","url":null,"abstract":"<div><h3>Objective</h3><div>Systems employing point-of-care (POC) INR monitoring with patient self-testing require test accuracy, data integrity, patient compliance, and prompt two-way communication for high quality warfarin management. With a goal of validating a POC Bluetooth capable device for prompt INR transfer to electronic medical record, two POC INR devices were compared against an internal plasma INR reference.</div></div><div><h3>Methods</h3><div>A multicenter study (February 14, 2023 – August 29, 2023) comparing concordance of two commercially available POC devices, Vantus and CoaguChek XS (Pro and Plus), against a plasma INR reference, was pursued among warfarin treated patients. Appropriateness of dosing decisions were assessed for each device.</div></div><div><h3>Results</h3><div>Across three Mayo Clinic sites, 151 warfarin treated patients agreed to participate. Atrial fibrillation (41.7 %), venous thromboembolism (33.1 %) and heart valve prosthesis (19.9 %) were common indications with target INR range 2.0–3.0 in 89 %. For the CoaguChek devices, 86.1 % of values fell within 0.4 INR units compared with plasma INR referent (CoaguChek - plasma INR correlation R<sup>2</sup> = 0.95). For the Vantus device, 88.7 % of values fell within 0.4 INR units of plasma INR values (Vantus – plasma INR correlation R<sup>2</sup> = 0.96). Mean (± standard deviation) deviation from plasma INR was 0.2 ± 0.3 for CoaguChek compared to 0.1 ± 0.2 for Vantus (<em>p</em> < 0.001). Using the plasma INR as the gold standard for dosing recommendations, appropriate dosing recommendations were similar between devices: CoaguChek 83.4 % vs Vantus 82.7 %.</div></div><div><h3>Conclusions</h3><div>Compared to a plasma referent, INR values obtained from the CoaguChek and Vantus devices exhibited strong correlation with plasma INR values without systemic bias.</div></div>","PeriodicalId":23064,"journal":{"name":"Thrombosis research","volume":"258 ","pages":"Article 109570"},"PeriodicalIF":3.4,"publicationDate":"2025-12-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145864826","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-20DOI: 10.1016/j.thromres.2025.109569
Ishan J. Tatake , Rishabh Singh , Caroline Cromwell , Brianna Bakow , Jacob Cogan , Manila Gaddh , Radhika Gangaraju , Ming Y. Lim , Colleen T. Morton , Andrew M. Peseski , Rachel P. Rosovsky , Kimberley Youkhana , Lisa Baumann Kreuziger
Background
The indications for anticoagulation and the number of patients on anticoagulation is rising. Accordingly, adverse drug events related to anticoagulation use are on the rise and represents an opportunity for improvement in patient safety. About 15–20 % of patients on anticoagulation undergo invasive procedures. Perioperative management of anticoagulation requires balancing competing risks of thrombosis and bleeding. Clear, concise and evidence-based institutional guidelines are essential for providers to make individualized treatment decisions and to improve patient safety.
Study design and methods
We qualitatively compared perioperative anticoagulation management guidelines from 11 US academic institutions. We also conducted a survey to evaluate how healthcare providers interpret perioperative anticoagulation management when different wording is used to convey recommendations.
Results
Institution-specific guidelines of the 11 US academic institutions varied in the management of perioperative anticoagulation and used different language to convey recommendations. In the survey, there was >90 % consensus amongst healthcare providers on the appropriate management of perioperative rivaroxaban and apixaban when the guidelines used the wording of “no dose day -X” which is used in the American College of Chest Physicians (CHEST) 2022 guidelines. Additionally, institution-specific guidelines were not available in 24.2 % of survey respondents.
Conclusions
This study demonstrates that institutions do not always have perioperative guidelines for anticoagulation management and when they do, there is variation in recommendations despite published international guidelines for perioperative management of anticoagulation. The language used to convey recommendations is important to standardizing perioperative anticoagulation management. These represent areas for further quality improvement and patient safety through anticoagulation stewardship.
{"title":"Qualitative comparison of perioperative anticoagulation management guidelines across US institutions","authors":"Ishan J. Tatake , Rishabh Singh , Caroline Cromwell , Brianna Bakow , Jacob Cogan , Manila Gaddh , Radhika Gangaraju , Ming Y. Lim , Colleen T. Morton , Andrew M. Peseski , Rachel P. Rosovsky , Kimberley Youkhana , Lisa Baumann Kreuziger","doi":"10.1016/j.thromres.2025.109569","DOIUrl":"10.1016/j.thromres.2025.109569","url":null,"abstract":"<div><h3>Background</h3><div>The indications for anticoagulation and the number of patients on anticoagulation is rising. Accordingly, adverse drug events related to anticoagulation use are on the rise and represents an opportunity for improvement in patient safety. About 15–20 % of patients on anticoagulation undergo invasive procedures. Perioperative management of anticoagulation requires balancing competing risks of thrombosis and bleeding. Clear, concise and evidence-based institutional guidelines are essential for providers to make individualized treatment decisions and to improve patient safety.</div></div><div><h3>Study design and methods</h3><div>We qualitatively compared perioperative anticoagulation management guidelines from 11 US academic institutions. We also conducted a survey to evaluate how healthcare providers interpret perioperative anticoagulation management when different wording is used to convey recommendations.</div></div><div><h3>Results</h3><div>Institution-specific guidelines of the 11 US academic institutions varied in the management of perioperative anticoagulation and used different language to convey recommendations. In the survey, there was >90 % consensus amongst healthcare providers on the appropriate management of perioperative rivaroxaban and apixaban when the guidelines used the wording of “no dose day -X” which is used in the American College of Chest Physicians (CHEST) 2022 guidelines. Additionally, institution-specific guidelines were not available in 24.2 % of survey respondents.</div></div><div><h3>Conclusions</h3><div>This study demonstrates that institutions do not always have perioperative guidelines for anticoagulation management and when they do, there is variation in recommendations despite published international guidelines for perioperative management of anticoagulation. The language used to convey recommendations is important to standardizing perioperative anticoagulation management. These represent areas for further quality improvement and patient safety through anticoagulation stewardship.</div></div>","PeriodicalId":23064,"journal":{"name":"Thrombosis research","volume":"257 ","pages":"Article 109569"},"PeriodicalIF":3.4,"publicationDate":"2025-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145828424","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-19DOI: 10.1016/j.thromres.2025.109566
Okan Yılmaz , Beyza Nur Yılmaz , Neslihan Betül Kandilcik , Zeynep Sebla Yiğit , Mediha Esra Altuntop Yayla
Hemostasis is a complex physiological process that prevents blood loss following vascular injury via the blood coagulation cascade. The coagulation cascade is a highly controlled stepwise process that establishes clotting only at the site of bleeding, when needed. Recently, aptamers have been employed not only in the fields of biosensors and diagnostics, but also in molecular imaging, therapeutics, and drug delivery systems. The present article highlights recent developments in aptamer-based biomedical systems for the diagnosis and treatment of blood coagulation cascade disorders. Specifically, aptasensors for thrombin detection and aptamer-based medical imaging of thrombi were addressed as diagnostic tools for coagulation cascade disorders. Additionally, the use of aptamers as pharmaceutical agents and aptamer-targeted drug delivery systems were highlighted as part of the treatment. In summary, this is a valuable compilation in this emerging field that focuses on aptamer-based applications for monitoring and treatment of blood coagulation cascade disorders.
{"title":"Aptamer-based monitorization and therapeutic applications of blood coagulation cascade disorders: A systematic review","authors":"Okan Yılmaz , Beyza Nur Yılmaz , Neslihan Betül Kandilcik , Zeynep Sebla Yiğit , Mediha Esra Altuntop Yayla","doi":"10.1016/j.thromres.2025.109566","DOIUrl":"10.1016/j.thromres.2025.109566","url":null,"abstract":"<div><div>Hemostasis is a complex physiological process that prevents blood loss following vascular injury <em>via</em> the blood coagulation cascade. The coagulation cascade is a highly controlled stepwise process that establishes clotting only at the site of bleeding, when needed. Recently, aptamers have been employed not only in the fields of biosensors and diagnostics, but also in molecular imaging, therapeutics, and drug delivery systems. The present article highlights recent developments in aptamer-based biomedical systems for the diagnosis and treatment of blood coagulation cascade disorders. Specifically, aptasensors for thrombin detection and aptamer-based medical imaging of thrombi were addressed as diagnostic tools for coagulation cascade disorders. Additionally, the use of aptamers as pharmaceutical agents and aptamer-targeted drug delivery systems were highlighted as part of the treatment. In summary, this is a valuable compilation in this emerging field that focuses on aptamer-based applications for monitoring and treatment of blood coagulation cascade disorders.</div></div>","PeriodicalId":23064,"journal":{"name":"Thrombosis research","volume":"258 ","pages":"Article 109566"},"PeriodicalIF":3.4,"publicationDate":"2025-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145864797","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-18DOI: 10.1016/j.thromres.2025.109568
XiaoMei Wang , SongQian Yang
{"title":"Letter to “Erythrocyte rheology is altered in haemophilia patients with advanced arthropathy. A case-control study”","authors":"XiaoMei Wang , SongQian Yang","doi":"10.1016/j.thromres.2025.109568","DOIUrl":"10.1016/j.thromres.2025.109568","url":null,"abstract":"","PeriodicalId":23064,"journal":{"name":"Thrombosis research","volume":"257 ","pages":"Article 109568"},"PeriodicalIF":3.4,"publicationDate":"2025-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145820863","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-17DOI: 10.1016/j.thromres.2025.109567
Tengyi Cai , Vincent Lu , Julie Wang , Mani Suleiman , Prahlad Ho , Hui Yin Lim
{"title":"Impact of ABO blood group on global coagulation assays","authors":"Tengyi Cai , Vincent Lu , Julie Wang , Mani Suleiman , Prahlad Ho , Hui Yin Lim","doi":"10.1016/j.thromres.2025.109567","DOIUrl":"10.1016/j.thromres.2025.109567","url":null,"abstract":"","PeriodicalId":23064,"journal":{"name":"Thrombosis research","volume":"257 ","pages":"Article 109567"},"PeriodicalIF":3.4,"publicationDate":"2025-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145790239","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Effective anticoagulant therapies are crucial for managing thrombotic disorders, especially in children. While currently available direct oral anticoagulants offer many advantages over current standard of care anticoagulants, including predictable pharmacokinetics and reduced need for monitoring, they still have significant bleeding risks. Milvexian, a direct factor XIa inhibitor, has demonstrated potential in reducing bleeding risks compared to traditional anticoagulants and warrants further investigation in neonates and children.
Objectives
This study aimed to investigate the age-related anticoagulant effect of milvexian in vitro.
Patients/methods
Plasma samples from healthy participants from the following age groups: neonates, 28 days–23 months, 2–6 years, 7–11 years, 12–18 years, and adults were spiked with increasing concentrations of milvexian (0.1, 1.0, 3.0 and 10 μM). Clotting time was measured using an activated partial thromboplastin time (aPTT) assay, and thrombin generation parameters were assessed.
Results
A dose-dependent increase in clotting time was observed across all age groups. Thrombin generation parameters, including Lag time and time to peak (ttPeak), showed a linear dose-dependent increase, while endogenous thrombin potential (ETP), Peak, and Velocity index decreased dose-dependently. Significant age-specific differences were noted primarily in neonates and children less than two years of age compared to adults.
Conclusion
In vitro findings indicate a predictable, linear dose-response to milvexian, with significant in vitro anticoagulant effect differences in neonates and children under two years of age. Further in vivo studies are required to confirm these findings, determine dosing strategies, and assess clinical implications in the paediatric population.
{"title":"The in vitro anticoagulant effect of milvexian in healthy neonates and children","authors":"Natasha Letunica , Vasiliki Karlaftis , Paul Monagle , Hernando Patino , Madhu Chintala , Chantal Attard","doi":"10.1016/j.thromres.2025.109564","DOIUrl":"10.1016/j.thromres.2025.109564","url":null,"abstract":"<div><h3>Background</h3><div>Effective anticoagulant therapies are crucial for managing thrombotic disorders, especially in children. While currently available direct oral anticoagulants offer many advantages over current standard of care anticoagulants, including predictable pharmacokinetics and reduced need for monitoring, they still have significant bleeding risks. Milvexian, a direct factor XIa inhibitor, has demonstrated potential in reducing bleeding risks compared to traditional anticoagulants and warrants further investigation in neonates and children.</div></div><div><h3>Objectives</h3><div>This study aimed to investigate the age-related anticoagulant effect of milvexian <em>in vitro.</em></div></div><div><h3>Patients/methods</h3><div>Plasma samples from healthy participants from the following age groups: neonates, 28 days–23 months, 2–6 years, 7–11 years, 12–18 years, and adults were spiked with increasing concentrations of milvexian (0.1, 1.0, 3.0 and 10 μM). Clotting time was measured using an activated partial thromboplastin time (aPTT) assay, and thrombin generation parameters were assessed.</div></div><div><h3>Results</h3><div>A dose-dependent increase in clotting time was observed across all age groups. Thrombin generation parameters, including Lag time and time to peak (ttPeak), showed a linear dose-dependent increase, while endogenous thrombin potential (ETP), Peak, and Velocity index decreased dose-dependently. Significant age-specific differences were noted primarily in neonates and children less than two years of age compared to adults.</div></div><div><h3>Conclusion</h3><div><em>In vitro</em> findings indicate a predictable, linear dose-response to milvexian, with significant <em>in vitro</em> anticoagulant effect differences in neonates and children under two years of age. Further <em>in vivo</em> studies are required to confirm these findings, determine dosing strategies, and assess clinical implications in the paediatric population.</div></div>","PeriodicalId":23064,"journal":{"name":"Thrombosis research","volume":"257 ","pages":"Article 109564"},"PeriodicalIF":3.4,"publicationDate":"2025-12-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145775879","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}