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Improvements in pharmacokinetics, bleeding control, and cost analysis after PK-guided transition to extended-half-life factor IX in hemophilia B: A multicentric study 血友病B患者在pk引导下过渡到延长半衰期因子IX后药代动力学、出血控制和成本分析的改善:一项多中心研究
IF 3.4 3区 医学 Q1 HEMATOLOGY Pub Date : 2026-01-06 DOI: 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.
延长半衰期因子IX浓缩物(FIX-EHL)已被证明可以改善血友病B (HB)患者的临床结果并减轻治疗负担。目的:分析重/中度HB患者从标准半衰期FIX (FIX- shl)转向FIX- ehl治疗前后一年药代动力学(PK)和临床参数的差异。方法:采用多中心、比较、观察、顺序、回顾性和多学科研究。采用WAPPS-Hemo®软件计算PK参数,记录年化总出血率(ABR)、关节出血率、t1/2比和曲线下面积(AUC)、FIX消耗、输注次数、成本。结果:共分析了21例HB患者(9例儿童和12例成人)从FIX-SHL切换到FIX-EHL。所有PK参数均显著改善,t1/2和AUC的中位改善率分别为4.1 (IQR: 3.4-4.8)和4.2 (IQR: 2.6-5.0)。临床结果方面,ABR差异有统计学意义,6例靶关节患者中,5例(83.3%)转换后得到缓解。注射频率和周剂量分别减少50.0%和56.3%,避免每位患者每年52.1 (IQR: 26.1-67.8)次注射和130357.3 (IQR: 5142.9- 203357.3) IU的FIX。然而,这一转变导致每位患者每年的额外费用为28,254.9欧元(IQR: 4432.1- 44,060.8)。结论:PK引导下从FIX-SHL切换到FIX-EHL与所有PK参数的改善有关,并且出血率的降低也证明了显著的临床益处。切换后,每周剂量和给药频率减少;然而,这并没有导致成本的降低。
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引用次数: 0
Efficacy of radiosynoviorthesis on clinical outcomes in persons with haemophilia. A systematic review and meta-analysis 放射性滑膜切开术对血友病患者临床预后的影响。系统回顾和荟萃分析
IF 3.4 3区 医学 Q1 HEMATOLOGY Pub Date : 2026-01-02 DOI: 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。
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引用次数: 0
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 开发一种决策支持工具,用于接受临终关怀的患者继续或减少抗血栓治疗的处方:欧洲德尔菲研究的结果
IF 3.4 3区 医学 Q1 HEMATOLOGY Pub Date : 2026-01-02 DOI: 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.
为了开发欧洲共享决策支持工具(SDST),采用两轮德尔菲过程来达成与抗血栓治疗(ATT)描述讨论和临终癌症患者过程相关方面的共识。德尔菲调查于2024年9月至2025年3月进行,由一个24人组成的多学科指导委员会(SC)制定,包括肿瘤学、血液学、姑息治疗、初级保健、老年医学和血管医学的医学专家。这项调查涉及来自8个欧洲国家的188名专家。共识被定义为与SC最终决定的一致度≥70%。主题包括描述时间、利益相关者、ATT、SDST患者的重新评估和临床驱动因素,以及评估SDST的随机对照试验(RCT)结果的选择。结果第1轮对7个汇总问题(37%)达成共识,尤其是对ATT处方的重新评估。考虑到这些结果,安理会重新制定了第二轮谈判,以减少歧义,朝着达成共识的方向迈进。最高法院做出了最后的决定。三种医学专业应参与ATT的处方:姑息治疗专家、肿瘤学家和在临床触发或3个月预后后的全科医生。对于SDST设计,研究结果证实该工具对临床医生有意义。为未来的RCT选择了11个预定义结果。结论:这些结果成功地塑造了未来SDST的内容,并绘制了其在整个欧洲姑息治疗临床路径中的可用性,以支持知情决策,减少并发症,提高这一人群的生活质量。
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引用次数: 0
Factors associated with venous and arterial thrombosis in patients with Systemic Lupus Erythematosus: A systematic review and meta-analysis 系统性红斑狼疮患者静脉和动脉血栓形成的相关因素:系统回顾和荟萃分析。
IF 3.4 3区 医学 Q1 HEMATOLOGY Pub Date : 2025-12-29 DOI: 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 ,&nbsp;Yuqiong Cao ,&nbsp;Yuhong He ,&nbsp;Shan Zeng ,&nbsp;Na Ye ,&nbsp;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}
引用次数: 0
Bluetooth enabled point-of-care INR device validation for warfarin management 蓝牙启用点护理INR设备验证华法林管理。
IF 3.4 3区 医学 Q1 HEMATOLOGY Pub Date : 2025-12-22 DOI: 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.
目的:采用患者自检的护理点(POC) INR监测系统要求检测准确性、数据完整性、患者依从性和及时的双向沟通,以实现高质量的华法林管理。为了验证具有POC蓝牙功能的设备是否能够及时将INR传输到电子医疗记录,我们将两个POC INR设备与内部等离子体INR参考进行了比较。方法:一项多中心研究(2023年2月14日- 2023年8月29日)在华法林治疗的患者中比较了两种市售POC装置Vantus和CoaguChek XS (Pro和Plus)与血浆INR参考的一致性。评估每个装置的给药决定的适当性。结果:在梅奥诊所的三个地点,151名接受华法林治疗的患者同意参与。房颤(41.7%)、静脉血栓栓塞(33.1%)和心脏瓣膜置换术(19.9%)是常见的适应症,89%的患者目标INR在2.0-3.0之间。对于CoaguChek装置,与血浆INR参考值相比,86.1%的值下降在0.4 INR单位以内(CoaguChek -血浆INR相关R2 = 0.95)。对于Vantus装置,88.7%的数值落在血浆INR值的0.4 INR单位内(Vantus -血浆INR相关R2 = 0.96)。CoaguChek与血浆INR的平均(±标准差)偏差为0.2±0.3,而Vantus为0.1±0.2 (p)。结论:与血浆参考物相比,CoaguChek和Vantus装置获得的INR值与血浆INR值具有很强的相关性,无系统偏倚。
{"title":"Bluetooth enabled point-of-care INR device validation for warfarin management","authors":"Robert D. McBane II ,&nbsp;Jennifer Lutz ,&nbsp;Carlee O'Connor ,&nbsp;Anna Kramer ,&nbsp;Michael Luker ,&nbsp;David Hodge ,&nbsp;Colleen S. Thomas ,&nbsp;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> &lt; 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}
引用次数: 0
Qualitative comparison of perioperative anticoagulation management guidelines across US institutions 美国各机构围手术期抗凝管理指南的定性比较。
IF 3.4 3区 医学 Q1 HEMATOLOGY Pub Date : 2025-12-20 DOI: 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.
背景:抗凝的适应症和抗凝患者的数量正在上升。因此,与抗凝使用相关的药物不良事件呈上升趋势,这为改善患者安全提供了机会。约15- 20%接受抗凝治疗的患者接受有创手术。围手术期抗凝治疗需要平衡血栓和出血的竞争风险。清晰、简明和基于证据的机构指南对于提供者做出个性化治疗决策和改善患者安全至关重要。研究设计和方法:我们对美国11家学术机构的围手术期抗凝治疗指南进行定性比较。我们还进行了一项调查,以评估当使用不同的措辞来传达建议时,医疗保健提供者如何解释围手术期抗凝管理。结果:美国11家学术机构的机构指南在围手术期抗凝治疗管理方面存在差异,并且使用了不同的语言来传达建议。在调查中,当指南使用美国胸科医师学会(Chest) 2022指南中使用的“无剂量日-X”措辞时,医疗保健提供者对利伐沙班和阿哌沙班围手术期的适当管理达成了约90%的共识。此外,24.2%的调查对象没有特定机构的指导方针。结论:本研究表明,各机构并不总是有围手术期抗凝管理指南,即使有,尽管已公布的国际抗凝围手术期管理指南,建议也存在差异。表达建议的语言对规范围手术期抗凝管理很重要。这些都代表了通过抗凝管理进一步提高质量和患者安全的领域。
{"title":"Qualitative comparison of perioperative anticoagulation management guidelines across US institutions","authors":"Ishan J. Tatake ,&nbsp;Rishabh Singh ,&nbsp;Caroline Cromwell ,&nbsp;Brianna Bakow ,&nbsp;Jacob Cogan ,&nbsp;Manila Gaddh ,&nbsp;Radhika Gangaraju ,&nbsp;Ming Y. Lim ,&nbsp;Colleen T. Morton ,&nbsp;Andrew M. Peseski ,&nbsp;Rachel P. Rosovsky ,&nbsp;Kimberley Youkhana ,&nbsp;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 &gt;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}
引用次数: 0
Aptamer-based monitorization and therapeutic applications of blood coagulation cascade disorders: A systematic review 基于适配体的凝血级联障碍监测和治疗应用:系统综述。
IF 3.4 3区 医学 Q1 HEMATOLOGY Pub Date : 2025-12-19 DOI: 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.
止血是一个复杂的生理过程,通过血凝级联防止血管损伤后的失血。凝血级联是一个高度控制的逐步过程,在需要时仅在出血部位建立凝血。近年来,适体不仅应用于生物传感器和诊断领域,还应用于分子成像、治疗和药物输送系统。本文重点介绍了用于诊断和治疗凝血级联疾病的适配体生物医学系统的最新进展。具体来说,用于凝血酶检测的适配体传感器和基于适配体的血栓医学成像被认为是凝血级联疾病的诊断工具。此外,适体作为药物制剂和适体靶向药物递送系统的使用被强调为治疗的一部分。总之,这是一个有价值的汇编在这个新兴领域,重点是基于适配体的应用监测和治疗凝血级联障碍。
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引用次数: 0
Letter to “Erythrocyte rheology is altered in haemophilia patients with advanced arthropathy. A case-control study” 致“血友病合并晚期关节病患者红细胞流变学改变”的信。病例对照研究”。
IF 3.4 3区 医学 Q1 HEMATOLOGY Pub Date : 2025-12-18 DOI: 10.1016/j.thromres.2025.109568
XiaoMei Wang , SongQian Yang
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引用次数: 0
Impact of ABO blood group on global coagulation assays ABO血型对整体凝血试验的影响
IF 3.4 3区 医学 Q1 HEMATOLOGY Pub Date : 2025-12-17 DOI: 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 ,&nbsp;Vincent Lu ,&nbsp;Julie Wang ,&nbsp;Mani Suleiman ,&nbsp;Prahlad Ho ,&nbsp;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}
引用次数: 0
The in vitro anticoagulant effect of milvexian in healthy neonates and children 米尔维昔安在健康新生儿和儿童中的体外抗凝作用。
IF 3.4 3区 医学 Q1 HEMATOLOGY Pub Date : 2025-12-13 DOI: 10.1016/j.thromres.2025.109564
Natasha Letunica , Vasiliki Karlaftis , Paul Monagle , Hernando Patino , Madhu Chintala , Chantal Attard

Background

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.
背景:有效的抗凝治疗对于治疗血栓性疾病至关重要,特别是在儿童中。虽然目前可获得的直接口服抗凝剂比目前的标准护理抗凝剂有许多优点,包括可预测的药代动力学和减少监测的需要,但它们仍然存在显著的出血风险。Milvexian是一种直接因子XIa抑制剂,与传统抗凝剂相比,已被证明具有降低出血风险的潜力,值得在新生儿和儿童中进一步研究。目的:研究密乐维安的年龄相关性体外抗凝作用。患者/方法:从以下年龄组的健康参与者的血浆样本中:新生儿、28天-23个月、2-6岁、7-11岁、12-18岁和成人中加入浓度升高的米尔维克斯胺(0.1、1.0、3.0和10 μM)。使用活化部分凝血活酶时间(aPTT)测定凝血时间,并评估凝血酶生成参数。结果:在所有年龄组中观察到凝血时间的剂量依赖性增加。凝血酶生成参数,包括滞后时间和峰值时间(ttPeak),呈剂量依赖性线性增加,而内源性凝血酶电位(ETP)、峰值和速度指数呈剂量依赖性下降。与成年人相比,主要在新生儿和两岁以下儿童中发现了显著的年龄特异性差异。结论:体外研究结果表明,米尔维昔安具有可预测的线性剂量反应,在新生儿和两岁以下儿童中具有显著的体外抗凝效果差异。需要进一步的体内研究来证实这些发现,确定给药策略,并评估在儿科人群中的临床意义。
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引用次数: 0
期刊
Thrombosis research
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