TH Open: Companion Journal to Thrombosis and Haemostasis最新文献

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Potential for a Virtual Care Model in the Perioperative Management of Anticoagulant Therapy: A 5-Year Retrospective Clinic Review. 虚拟护理模式在抗凝治疗围手术期管理中的潜力:一项5年回顾性临床回顾。
TH Open: Companion Journal to Thrombosis and Haemostasis Pub Date : 2023-07-01 DOI: 10.1055/a-2098-6782
James Luke Douketis, Sam Schulman
{"title":"Potential for a Virtual Care Model in the Perioperative Management of Anticoagulant Therapy: A 5-Year Retrospective Clinic Review.","authors":"James Luke Douketis,&nbsp;Sam Schulman","doi":"10.1055/a-2098-6782","DOIUrl":"https://doi.org/10.1055/a-2098-6782","url":null,"abstract":"<p><p><b>Background</b>  With a trend toward greater virtual care in selected clinical settings, perioperative anticoagulant management appears well suited for this care delivery model. We explored the potential for virtual care among patients who are receiving anticoagulant therapy and require perioperative management around the time of an elective surgery/procedure. <b>Methods</b>  We undertook a retrospective review of patients who were receiving anticoagulant therapy, either a direct oral anticoagulant (DOAC) or warfarin, assessed in a perioperative anticoagulation-bridging clinic over a 5-year period from 2016 to 2020. Using prespecified criteria, we determined the proportion of patients who likely would be suitable for virtual care (receiving a DOAC or warfarin and having a minimal- or low-/moderate-bleed-risk surgery/procedure), those who likely would be suitable for in-person care (receiving warfarin and requiring heparin bridging for a mechanical heart valve), and patients who would be suitable for either care delivery model (receiving a DOAC or warfarin, but not with a mechanical heart valve, and requiring a high-bleed-risk surgery/procedure). <b>Results</b>  During the 5-year study period, there were 4,609 patients assessed for perioperative anticoagulant management in whom the most widely used anticoagulants were warfarin (37%), apixaban (30%), and rivaroxaban (24%). Within each year assessed, 4 to 20% of all patients were undergoing a minimal-bleed-risk procedure, 76 to 82% were undergoing a low-/moderate-bleed-risk surgery/procedure, and 10 to 39% were undergoing a high-bleed-risk surgery/procedure. The proportion of patients considered suitable for virtual, in-person, or either virtual or in-person management was 79.6, 7.1, and 13.3%, respectively. <b>Conclusion</b>  In patients who were assessed in a perioperative anticoagulation clinic, there was a high proportion of patients in whom a virtual care model might be suitable.</p>","PeriodicalId":22238,"journal":{"name":"TH Open: Companion Journal to Thrombosis and Haemostasis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10322226/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9796209","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Peripheral Arterial Thrombosis following Russell's Viper Bites. 被罗素蝰蛇咬伤后出现外周动脉血栓。
TH Open: Companion Journal to Thrombosis and Haemostasis Pub Date : 2023-06-17 eCollection Date: 2023-04-01 DOI: 10.1055/s-0043-1769625
Subramanian Senthilkumaran, Ketan Patel, Elanchezhian Rajan, Pradeep Vijayakumar, Stephen W Miller, Alexandra Rucavado, Soheil Gilabadi, Medha Sonavane, Nicholas J Richards, Jarred Williams, Harry F Williams, Steven A Trim, Ponniah Thirumalaikolundusubramanian, José María Gutiérrez, Sakthivel Vaiyapuri
{"title":"Peripheral Arterial Thrombosis following Russell's Viper Bites.","authors":"Subramanian Senthilkumaran, Ketan Patel, Elanchezhian Rajan, Pradeep Vijayakumar, Stephen W Miller, Alexandra Rucavado, Soheil Gilabadi, Medha Sonavane, Nicholas J Richards, Jarred Williams, Harry F Williams, Steven A Trim, Ponniah Thirumalaikolundusubramanian, José María Gutiérrez, Sakthivel Vaiyapuri","doi":"10.1055/s-0043-1769625","DOIUrl":"10.1055/s-0043-1769625","url":null,"abstract":"<p><p>Envenomings by Russell's viper ( <i>Daboia russelii</i> ), a species of high medical importance in India and other Asian countries, commonly result in hemorrhage, coagulopathies, necrosis, and acute kidney injury. Although bleeding complications are frequently reported following viper envenomings, thrombotic events occur rarely (reported only in coronary and carotid arteries) with serious consequences. For the first time, we report three serious cases of peripheral arterial thrombosis following Russell's viper bites and their diagnostic, clinical management, and mechanistic insights. These patients developed occlusive thrombi in their peripheral arteries and symptoms despite antivenom treatment. In addition to clinical features, computed tomography angiography was used to diagnose arterial thrombosis and ascertain its precise locations. They were treated using thrombectomy or amputation in one case that presented with gangrenous digits. Mechanistic insights into the pathology through investigations revealed the procoagulant actions of Russell's viper venom in standard clotting tests as well as in rotational thromboelastometry analysis. Notably, Russell's viper venom inhibited agonist-induced platelet activation. The procoagulant effects of Russell's viper venom were inhibited by a matrix metalloprotease inhibitor, marimastat, although a phospholipase A <sub>2</sub> inhibitor (varespladib) did not show any inhibitory effects. Russell's viper venom induced pulmonary thrombosis when injected intravenously in mice and thrombi in the microvasculature and affected skeletal muscle when administered locally. These data emphasize the significance of peripheral arterial thrombosis in snakebite victims and provide awareness, mechanisms, and robust strategies for clinicians to tackle this issue in patients.</p>","PeriodicalId":22238,"journal":{"name":"TH Open: Companion Journal to Thrombosis and Haemostasis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-06-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10276757/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9716765","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Adjudicating the Diagnosis of Immune Thrombocytopenia in a Clinical Research Study. 判定免疫性血小板减少症诊断的临床研究。
TH Open: Companion Journal to Thrombosis and Haemostasis Pub Date : 2023-04-28 eCollection Date: 2023-04-01 DOI: 10.1055/s-0043-57226
Caroline Gabe, Syed Mahamad, Melanie St John, Joanne Duncan, John G Kelton, Donald M Arnold
{"title":"Adjudicating the Diagnosis of Immune Thrombocytopenia in a Clinical Research Study.","authors":"Caroline Gabe, Syed Mahamad, Melanie St John, Joanne Duncan, John G Kelton, Donald M Arnold","doi":"10.1055/s-0043-57226","DOIUrl":"10.1055/s-0043-57226","url":null,"abstract":"","PeriodicalId":22238,"journal":{"name":"TH Open: Companion Journal to Thrombosis and Haemostasis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10147499/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9443228","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Quantitative Risk Evaluation of Adventitious Agents in Heparin. 肝素中不确定因子的定量风险评价。
TH Open: Companion Journal to Thrombosis and Haemostasis Pub Date : 2023-04-01 DOI: 10.1055/s-0043-1768946
John Raedts, Edwin Kellenbach
{"title":"Quantitative Risk Evaluation of Adventitious Agents in Heparin.","authors":"John Raedts,&nbsp;Edwin Kellenbach","doi":"10.1055/s-0043-1768946","DOIUrl":"https://doi.org/10.1055/s-0043-1768946","url":null,"abstract":"<p><p>Heparin is typically extracted from domestic pigs, which may carry zoonotic adventitious agents. Prion and viral safety cannot be assured by testing the active pharmaceutical ingredient itself; instead for the evaluation of the adventitious agent (i.e., viruses/prions) safety of heparin and heparinoid (e.g., Orgaran or Sulodexide) therapeutics, a risk assessment is required. An approach is presented which provides a quantitative estimation of the worst-case potential residual adventitious agent (i.e., GC/mL or ID <sub>50</sub> ) present in a maximum daily dose of heparin. This estimation is based on the input (determined by prevalence, titer, and amount of starting material to prepare a maximum daily dose) and validated reduction by the manufacturing process, resulting in an estimation of the worst-case potential level of adventitious agent present in a maximum daily dose. The merits of this quantitative, worst-case approach are evaluated. The approach described in this review provides a tool for a quantitative risk evaluation of the viral and prion safety of heparin.</p>","PeriodicalId":22238,"journal":{"name":"TH Open: Companion Journal to Thrombosis and Haemostasis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10200340/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9569478","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Antithrombotic Effects of the Novel Small-Molecule Factor XIa Inhibitor Milvexian in a Rabbit Arteriovenous Shunt Model of Venous Thrombosis. 新型小分子因子XIa抑制剂Milvexian在兔动静脉分流静脉血栓模型中的抗血栓作用。
TH Open: Companion Journal to Thrombosis and Haemostasis Pub Date : 2023-04-01 DOI: 10.1055/a-2061-3311
Xinkang Wang, Qiu Li, Fuyong Du, Neetu Shukla, Andrea R Nawrocki, Madhu Chintala
{"title":"Antithrombotic Effects of the Novel Small-Molecule Factor XIa Inhibitor Milvexian in a Rabbit Arteriovenous Shunt Model of Venous Thrombosis.","authors":"Xinkang Wang,&nbsp;Qiu Li,&nbsp;Fuyong Du,&nbsp;Neetu Shukla,&nbsp;Andrea R Nawrocki,&nbsp;Madhu Chintala","doi":"10.1055/a-2061-3311","DOIUrl":"https://doi.org/10.1055/a-2061-3311","url":null,"abstract":"<p><p><b>Background</b>  Factor XIa (FXIa) is an emerging therapeutic target, and FXIa inhibition is a promising mechanism to improve therapeutic index over current anticoagulants. Milvexian (BMS-986177/JNJ-70033093) is an oral small-molecule FXIa inhibitor. <b>Objective</b>  Milvexian's antithrombotic efficacy was characterized in a rabbit arteriovenous (AV) shunt model of venous thrombosis and compared with the factor Xa inhibitor apixaban and the direct thrombin inhibitor dabigatran. <b>Methods</b>  The AV shunt model of thrombosis was conducted in anesthetized rabbits. Vehicle or drugs were administered as intravenous bolus plus a continuous infusion. Thrombus weight was the primary efficacy endpoint. Ex vivo activated partial thromboplastin time (aPTT), prothrombin time (PT), and thrombin time (TT) were measured as the pharmacodynamic responses. <b>Results</b>  Milvexian dose dependently reduced thrombus weights by 34.3 ± 7.9, 51.6 ± 6.8 ( <i>p</i>  < 0.01; <i>n</i>  = 5), and 66.9 ± 4.8% ( <i>p</i>  < 0.001; <i>n</i>  = 6) versus vehicle at 0.25 + 0.17, 1.0 + 0.67, and 4.0 ± 2.68 mg/kg bolus + mg/kg/h infusion, respectively. Ex vivo clotting data supported a dose-dependent prolongation of aPTT (with 1.54-, 2.23-, and 3.12-fold increases from baseline upon the AV shunt start), but no changes in PT and TT. Dose-dependent inhibition in thrombus weight and clotting assays was also demonstrated for both apixaban and dabigatran as the references for the model validation. <b>Conclusion</b>  Results demonstrate that milvexian is an effective anticoagulant for prevention of venous thrombosis in the rabbit model, which supports the utility of milvexian in venous thrombosis, as seen in the phase 2 clinical study.</p>","PeriodicalId":22238,"journal":{"name":"TH Open: Companion Journal to Thrombosis and Haemostasis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10125780/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9349307","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Platelets and the Lectin Pathway of Complement Activation in Patients with Systemic Lupus Erythematosus or Antiphospholipid Syndrome. 系统性红斑狼疮或抗磷脂综合征患者的血小板和补体激活凝集素途径。
TH Open: Companion Journal to Thrombosis and Haemostasis Pub Date : 2023-04-01 DOI: 10.1055/a-2087-0314
Signe Risbøl Vils, Anne Troldborg, Anne-Mette Hvas, Steffen Thiel
{"title":"Platelets and the Lectin Pathway of Complement Activation in Patients with Systemic Lupus Erythematosus or Antiphospholipid Syndrome.","authors":"Signe Risbøl Vils,&nbsp;Anne Troldborg,&nbsp;Anne-Mette Hvas,&nbsp;Steffen Thiel","doi":"10.1055/a-2087-0314","DOIUrl":"https://doi.org/10.1055/a-2087-0314","url":null,"abstract":"<p><p><b>Background</b>  Patients with systemic lupus erythematosus (SLE) have an increased risk of thrombosis even when they do not have antiphospholipid syndrome (APS). Interactions between complement activation and activated platelets have been suggested in SLE and APS and could play a role in the increased thrombosis risk. <b>Objectives</b>  To explore factors potentially related to the prothrombotic pathophysiology in patients with SLE, primary APS, and healthy controls, by investigating lectin pathway proteins (LPPs), complement activation, platelet aggregation, and platelet activation. <b>Methods</b>  This cross-sectional cohort study included 20 SLE patients, 17 primary APS, and 39 healthy controls. Flow cytometry and light transmission aggregometry were used to assess platelet activation and aggregation. Using time-resolved immunofluorometric assays, the plasma concentrations of 11 LPPs and C3dg, reflecting complement activation, were measured. <b>Results</b>  H-ficolin plasma concentrations were higher in SLE and APS patients than in controls ( <i>p</i>  = 0.01 and <i>p</i>  = 0.03). M-ficolin was lower in SLE than in APS ( <i>p</i>  = 0.01) and controls ( <i>p</i>  = 0.03). MAp19 was higher in APS patients than in SLE patients ( <i>p</i>  = 0.01) and controls ( <i>p</i>  < 0.001). In APS patients, MASP-2 and C3dg correlated negatively with platelet activation. Platelet-bound fibrinogen after agonist stimulation and C3dg concentrations correlated negatively with platelet activation. <b>Conclusion</b>  We observed significant differences between SLE and APS patients regarding complement proteins and platelet activation. Particularly the negative correlations between MASP-2 and C3dg with platelet activation only observed in APS patients suggest that interactions between complement activation and platelets differ in SLE and APS.</p>","PeriodicalId":22238,"journal":{"name":"TH Open: Companion Journal to Thrombosis and Haemostasis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/c5/61/10-1055-a-2087-0314.PMC10270747.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9716761","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Prolonged Fasting as a Cause of Deep Vein Thrombosis: A Case Report. 长时间禁食是深静脉血栓形成的原因:1例报告。
TH Open: Companion Journal to Thrombosis and Haemostasis Pub Date : 2023-04-01 DOI: 10.1055/s-0043-57225
Guillaume Roberge, Carine Samson, Grégoire Le Gal, Anthony Calabrino
{"title":"Prolonged Fasting as a Cause of Deep Vein Thrombosis: A Case Report.","authors":"Guillaume Roberge,&nbsp;Carine Samson,&nbsp;Grégoire Le Gal,&nbsp;Anthony Calabrino","doi":"10.1055/s-0043-57225","DOIUrl":"https://doi.org/10.1055/s-0043-57225","url":null,"abstract":"<p><p><b>Background</b>  Intermittent fasting is becoming more popular as health benefits are described in recent literature. Various forms of fasting exist, one of them involving a zero-calorie diet and drinking only water. However, the safety of water-only fasting is still not well established. We report a case of a man who developed a lower limb deep vein thrombosis at the end of a 2-week water-only fasting and characterized by an initial period of 5 days of no food and no water intake. We reviewed literature regarding potential links between fasting and venous thromboembolism (VTE). <b>Clinical Approach</b>  We believe that fasting can induce important dehydration, leading to hypercoagulability and then contribute to the development of a venous thrombosis. The patient was treated with apixaban for 3 months as is recommended in patients with a provoked event caused by a transient risk factor. No thrombotic recurrence was observed during the 6-month follow-up. <b>Conclusion</b>  The public needs to be aware of the potential life-threatening complications associated with important dehydration in the setting of medically unsupervised fasting, and these might include VTE. Whether a VTE with dehydration as the only identified risk factor should be approached as a low recurrence risk situation or not still needs to be clarified.</p>","PeriodicalId":22238,"journal":{"name":"TH Open: Companion Journal to Thrombosis and Haemostasis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10118710/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9756726","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Identification of High Platelet Reactivity Despite ADP P2Y 12 Inhibitor Treatment: Two Populations in the Vasodilator-Stimulated Phosphoprotein Assay and Variable PFA-P2Y Shapes of Curve. ADP p2y12抑制剂治疗后血小板高反应性的鉴定:血管扩张剂刺激磷酸化蛋白测定和可变PFA-P2Y曲线形状的两种人群
TH Open: Companion Journal to Thrombosis and Haemostasis Pub Date : 2023-04-01 DOI: 10.1055/a-2075-7979
Cyril Mariethoz, Emmanuelle Scala, Elena Matthey-Guirao, Jean-Benoît Rossel, Francisco Javier Gomez, Francesco Grandoni, Carlo Marcucci, Lorenzo Alberio
{"title":"Identification of High Platelet Reactivity Despite ADP P2Y <sub>12</sub> Inhibitor Treatment: Two Populations in the Vasodilator-Stimulated Phosphoprotein Assay and Variable PFA-P2Y Shapes of Curve.","authors":"Cyril Mariethoz,&nbsp;Emmanuelle Scala,&nbsp;Elena Matthey-Guirao,&nbsp;Jean-Benoît Rossel,&nbsp;Francisco Javier Gomez,&nbsp;Francesco Grandoni,&nbsp;Carlo Marcucci,&nbsp;Lorenzo Alberio","doi":"10.1055/a-2075-7979","DOIUrl":"https://doi.org/10.1055/a-2075-7979","url":null,"abstract":"<p><p><b>Introduction</b>  Response to ADP P2Y <sub>12</sub> receptor inhibition by clopidogrel can be evaluated by various techniques. Here, we compared a functional rapid point-of-care technique (PFA-P2Y) with the degree of biochemical inhibition assessed by the VASP/P2Y <sub>12</sub> assay. <b>Methods</b>  Platelet response to clopidogrel was investigated in 173 patients undergoing elective intracerebral stenting (derivation cohort <i>n</i>  = 117; validation cohort <i>n</i>  = 56). High platelet reactivity (HPR) was defined as PFA-P2Y occlusion time <106 seconds or VASP/P2Y <sub>12</sub> platelet reactivity index (PRI) >50%. <b>Results</b>  In the derivation cohort, receiver operator characteristics analysis for the ability of PFA-P2Y to detect biochemical HPR showed high specificity (98.4%) but poor sensitivity (20.0%) and a very low area under the curve (0.59). The VASP/P2Y <sub>12</sub> assay revealed two coexisting platelet populations with different levels of vasodilator-stimulated phosphoprotein (VASP) phosphorylation: a fraction of highly phosphorylated, inhibited platelets and another of poorly phosphorylated, reactive platelets. Analysis of the PFA-P2Y curve shape revealed different types, categorized by time of occlusion (<106 seconds, 106 to 300 seconds, >300 seconds), and pattern (regular, irregular, and atypical). Noteworthy, curves with late occlusion and permeable curves with an irregular or atypical pattern correlated with VASP-PRI >50% and smaller sizes of the inhibited platelet subpopulation. Considering the PFA-P2Y shape of the curve for the detection of HPR improved sensitivity (72.7%) and preserved specificity (91.9%), with a rather high AUC (0.823). The validation cohort confirmed the VASP/P2Y <sub>12</sub> assay data and the usefulness of considering the PFA-P2Y curve shape. <b>Conclusion</b>  In patients treated with acetylsalicylic acid and clopidogrel for 7-10 days, the VASP/P2Y <sub>12</sub> assay reveals two coexisting subpopulations of differentially inhibited platelets, whose relative sizes predict global PRI and distinct PFA-P2Y curve patterns, indicating incomplete clopidogrel efficacy. The detailed analysis of both VASP/P2Y <sub>12</sub> and PFA-P2Y is necessary for optimal detection of HPR.</p>","PeriodicalId":22238,"journal":{"name":"TH Open: Companion Journal to Thrombosis and Haemostasis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10247305/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9612965","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Design of a Real-World Observational Study in Previously Untreated and Minimally Treated Hemophilia A Patients: Protect-NOW. 一项真实世界观察性研究的设计,在以前未治疗和最低限度治疗的a型血友病患者中:Protect-NOW。
TH Open: Companion Journal to Thrombosis and Haemostasis Pub Date : 2023-04-01 DOI: 10.1055/s-0043-1768464
Johannes Oldenburg, Susan Halimeh, Georgina W Hall, Robert Klamroth, Pascual Marco Vera, Martina Jansen, Mary Mathias
{"title":"Design of a Real-World Observational Study in Previously Untreated and Minimally Treated Hemophilia A Patients: Protect-NOW.","authors":"Johannes Oldenburg,&nbsp;Susan Halimeh,&nbsp;Georgina W Hall,&nbsp;Robert Klamroth,&nbsp;Pascual Marco Vera,&nbsp;Martina Jansen,&nbsp;Mary Mathias","doi":"10.1055/s-0043-1768464","DOIUrl":"https://doi.org/10.1055/s-0043-1768464","url":null,"abstract":"<p><p><b>Background</b>  The efficacy, safety, and immunogenicity of each of Octapharma's factor VIII (FVIII) products, Nuwiq, octanate, and wilate, have been investigated in previously untreated patients (PUPs) with severe hemophilia A in prospective clinical trials. The aim of the Protect-NOW study is to evaluate the effectiveness, safety, and utilization patterns of Nuwiq, octanate, and wilate in PUPs and minimally treated patients (MTPs; <5 exposure days [EDs] to FVIII concentrates or other blood products containing FVIII) with severe hemophilia A in a real-world setting. Real-world data provide valuable information that complement data obtained from interventional clinical trials. <b>Methods</b>  Protect-NOW (ClinicalTrials.gov identifier: NCT03695978; ISRCTN identifier: 11492145) is a real-world study in PUPs and MTPs treated with either the human cell line-derived recombinant FVIII Nuwiq (simoctocog alfa) or a plasma-derived FVIII concentrate containing von Willebrand factor (octanate or wilate). It is a prospective and (partly) retrospective, observational, international, noncontrolled, noninterventional study. A total of 140 PUPs and MTPs with severe hemophilia A will be enrolled across around 50 specialized centers worldwide and followed for either 100 EDs or a maximum period of 3 years from ED1. The primary objectives are to assess effectiveness in the prevention and treatment of bleeding episodes and overall safety, including inhibitor development. The secondary objectives are to assess utilization patterns (including dosage and frequency of administration) and the effectiveness in surgical prophylaxis. <b>Conclusions</b>  The Protect-NOW study will provide information on the treatment of PUPs and MTPs in routine clinical practice, which will help guide clinical decision making for treating these patients in the future.</p>","PeriodicalId":22238,"journal":{"name":"TH Open: Companion Journal to Thrombosis and Haemostasis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/d3/aa/10-1055-s-0043-1768464.PMC10171993.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9472956","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Geographical Variation in the Use of Oral Anticoagulation and Clinical Outcomes among Patients with Atrial Fibrillation in Denmark, Sweden, and Finland. 丹麦、瑞典和芬兰房颤患者口服抗凝剂使用和临床结果的地理差异
TH Open: Companion Journal to Thrombosis and Haemostasis Pub Date : 2023-04-01 DOI: 10.1055/a-2080-6171
Lars Frost, Olli Halminen, Mika Lehto, K E Juhani Airaksinen, Tomas Andersson, Per Wändell, Martin Holzmann, Pia Cordsen, Nicklas Vinter, Søren Paaske Johnsen
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