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Keywords = conventional factor VIII

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11 pages, 523 KiB  
Article
Altuvoct: Innovative Medicinal Products Benefit from Innovative Approaches to Regulatory Assessment
by Essam Kerwash, Maria Malamatari and John D. Johnston
Life 2025, 15(6), 848; https://doi.org/10.3390/life15060848 - 24 May 2025
Viewed by 564
Abstract
Efanesoctocog alfa (Altuvoct; BIVV001) is a fusion protein comprising domains of (i) factor VIII, (ii) the von Willebrand factor, and (iii) IgG1 coupled to two polypeptide linkers. The half-life of efanesoctocog alfa in plasma is about 40 h. The polypeptide linkers are released [...] Read more.
Efanesoctocog alfa (Altuvoct; BIVV001) is a fusion protein comprising domains of (i) factor VIII, (ii) the von Willebrand factor, and (iii) IgG1 coupled to two polypeptide linkers. The half-life of efanesoctocog alfa in plasma is about 40 h. The polypeptide linkers are released by thrombin activation, resulting in an active form of efanesoctocog alfa that results in the formation of a fibrin clot. Data from two single-arm ongoing studies were submitted: the XTEND-1 study enrolled 159 subjects aged 12–72 years, and the XTEND-kids study enrolled 74 subjects aged <12 years; all subjects had severe haemophilia A. Single-arm studies are not amenable to conventional statistical analysis of ‘effect of cause’, and so a supplementary analysis was conducted on the basis of ‘cause of effect’, making use of the scheme described by Toulmin coupled to an analysis of causal inference. Overall, the claim that Altuvoct is indicated to treat people aged ≥2 years with severe (and moderate) haemophilia A was considered to be supported by the results of the submitted studies and associated modelling exercises; the benefit–risk evaluation of Altuvoct was found to be positive in the target population. Full article
(This article belongs to the Section Medical Research)
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10 pages, 479 KiB  
Article
Evaluation of Coagulation Factors and Platelet Activation in Patients Undergoing Complex Endovascular Para-Renal and Thoraco-Abdominal Aneurysm Repair: The Protocol of a Prospective Observational Study
by Maria P. Ntalouka, Konstantinos Spanos, Paraskevi Kotsi, Aikaterini Bouzia, Georgios Kouvelos, Diamanto Aretha, Efthymia Petinaki, Athanasios Giannnoukas, Miltiadis Matsagkas and Eleni M. Arnaoutoglou
J. Clin. Med. 2025, 14(9), 3105; https://doi.org/10.3390/jcm14093105 - 30 Apr 2025
Cited by 2 | Viewed by 415
Abstract
Background/Objectives: Endovascular aneurysm repair (EVAR) of the aorta may trigger an inflammatory response that affects coagulation. In the EVAR of para-renal and thoraco-abdominal aortic aneurysms, the implants are more complex and the duration of surgery is longer. However, the exact pathophysiological mechanisms of [...] Read more.
Background/Objectives: Endovascular aneurysm repair (EVAR) of the aorta may trigger an inflammatory response that affects coagulation. In the EVAR of para-renal and thoraco-abdominal aortic aneurysms, the implants are more complex and the duration of surgery is longer. However, the exact pathophysiological mechanisms of coagulation activation are not yet well understood. The primary aim of this study is to investigate the effects of complex EVAR of para-renal and thoraco-abdominal aortic aneurysms on the coagulation status of patients. Methods: This prospective observational study (STROBE), approved and registered by the Ethics Committee of the University Hospital of Larissa (UHL) (NCT06432387), will enroll consecutive patients undergoing elective EVAR of para-renal and thoraco-abdominal aortic aneurysms. Exclusion criteria: Refusal to participate, previous surgery within 3 months, American Society of Anesthesiologists physical status (ASA PS) > 3, known history of thrombophilia or functional platelet dysfunction. Perioperative laboratory tests will be performed according to institutional guidelines. These include a complete blood count, conventional coagulation tests, and kidney and liver function tests. In addition, the following parameters will be determined: von Willebrand factor, factors VIII and XI, D-dimers, fibrinogen, Adamts-13, anti-Xa, platelet activation (multiplate), and high-sensitivity troponin. Blood samples will be taken pre-operatively before induction of anesthesia (01), on postoperative day 1 (02), and on postoperative day 3–4 (03). During hospitalization, myocardial injury after non-cardiac surgery (MINS), major adverse cardiovascular events after non-cardiac surgery (MACE), acute kidney injury (AKI), post-implantation syndrome (PIS), and death from any cause will be recorded. In addition, our patients will be reviewed at 30 days, 3, 6, and 12 months for MACE, implant failure, or death from any cause. All enrolled patients will be treated by the same medical team at UHL according to the indications. According to our power analysis, for a cohort of patients with three consecutive measurements, 58 patients should be included in the study. To compensate for possible dropouts, the sample size was increased to 65 patients. Conclusions: The results of the present study could help physicians to better understand the effects of complex EVAR of para-renal and thoraco-abdominal aortic aneurysms on blood coagulation and platelet activation. Full article
(This article belongs to the Section Anesthesiology)
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19 pages, 10070 KiB  
Article
MCPSHA: A New Tool for Probabilistic Seismic Hazard Analysis Based on Monte Carlo Simulation
by Xiaoyi Shao, Xiaoqing Wang, Chong Xu and Siyuan Ma
Appl. Sci. 2024, 14(3), 1079; https://doi.org/10.3390/app14031079 - 26 Jan 2024
Viewed by 2385
Abstract
The utilization of the Monte Carlo method in conjunction with probabilistic seismic hazard analysis (PSHA) constitutes a compelling avenue for exploration. This approach presents itself as an efficient and adaptable alternative to conventional PSHA, particularly when confronted with intricate factors such as parameter [...] Read more.
The utilization of the Monte Carlo method in conjunction with probabilistic seismic hazard analysis (PSHA) constitutes a compelling avenue for exploration. This approach presents itself as an efficient and adaptable alternative to conventional PSHA, particularly when confronted with intricate factors such as parameter uncertainties and diverse earthquake source models. Leveraging the Monte Carlo method and drawing from the widely adopted Cornell-type seismicity model in engineering seismology and disaster mitigation, as well as a seismicity model capturing temporal, spatial, and magnitude inhomogeneity, we have derived a formula for the probability of earthquake intensity occurrence and the mean rate of intensity occurrence over a specified time period. This effort has culminated in the development of a MATLAB-based program named MCPSHA. To assess the model’s efficacy, we selected Baoji City, Shaanxi Province, China, as our research site. Our investigation delves into the disparity between occurrence probability and extreme probability (a surrogate commonly employed for occurrence probability) in the Baoji region over the next 50 years. The findings reveal that the Western region of Baoji exhibits a heightened hazard level, as depicted in the maps, which illustrate a 10% probability of exceedance within a 50-year timeframe. The probability of earthquake occurrence under various intensities (VI, VII, and VIII) over 50 years follows a declining trend from west to east. Furthermore, the likelihood of seismic intensity exceeding VI, VII, and VIII indicates the lowest exceeding probability in the northeast and the highest in the northwest. Notably, for intensities VI-VII, the difference between occurrence probability and extreme probability approaches twice, gradually diminishing with increasing intensity. This study underscores the MCPSHA model’s efficacy in providing robust technical support for mitigating earthquake risk and enhancing the precision of earthquake insurance premium rate calculations. Full article
(This article belongs to the Section Earth Sciences)
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23 pages, 6444 KiB  
Article
Reverse Micellar Dyeing of Cotton Fabric with Reactive Dye Using Biodegradable Non-Ionic Surfactant as Nanoscale Carrier: An Optimisation Study by One-Factor-at-One-Time Approach
by Yiu Lun Alan Tang, Shixin Jin, Cheng Hao Lee, Ho Shing Law, Jiali Yu, Yanming Wang and Chi-wai Kan
Polymers 2023, 15(20), 4175; https://doi.org/10.3390/polym15204175 - 20 Oct 2023
Cited by 8 | Viewed by 2578
Abstract
This study investigates the feasibility of using biodegradable secondary alcohol ethoxylate (SAE) non-ionic surfactant as a building block for the formation of reverse micelles, functioning as reactive dye carriers for the dyeing of cotton fabric in non-aqueous octane medium. Ten dyeing parameters were [...] Read more.
This study investigates the feasibility of using biodegradable secondary alcohol ethoxylate (SAE) non-ionic surfactant as a building block for the formation of reverse micelles, functioning as reactive dye carriers for the dyeing of cotton fabric in non-aqueous octane medium. Ten dyeing parameters were optimised, by a one-factor-at-a-time approach, namely: (i) effect of colour fixation agent; (ii) surfactant-to-water mole ratio; (iii) surfactant-to-co-surfactant mole ratio; (iv) volume of soda ash; (v) volume of dye; (vi) solvent-to-cotton ratio; (vii) dyeing temperature; (viii) dyeing time; (ix) fixation time; (x) soda-ash-to-cotton ratio. The colour properties, fastness properties and physical properties of SAE-dyed samples were experimentally compared with the conventional water-dyed samples. The optimised condition was found when SAE samples were dyed as follows: (a) 1:20 surfactant-to-water ratio; (b) 1:8 surfactant-to-co-surfactant ratio; (c) 10:1 solvent ratio; (d) 40 min dyeing time; (e) 60 min fixation time; and (f) 70 °C dyeing and fixation temperature. The results showed that SAE-dyed samples have better colour strength, lower reflectance percentage and comparable levelness, fastness and physical properties than that of water-dyed samples. SEM images revealed that the dyed cotton fibres had no severe surface damage caused by an SAE-based reverse micellar dyeing system. The TEM image depicts that the reverse micelle was of nanoscale, spherical-shaped and had a core–shell structure, validating the presence of reverse micelle as a reactive dye carrier and the potential of an SAE-based reverse micellar system for dyeing of cotton fabrics. Full article
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12 pages, 3590 KiB  
Article
Influence of Three Different Surgical Techniques on Microscopic Damage of Saphenous Vein Grafts—A Randomized Study
by Igor Zivkovic, Stasa Krasic, Milica Stankovic, Petar Milacic, Aleksandar Milutinovic, Djordje Zdravkovic, Zoran Tabakovic, Miodrag Peric, Miljan Krstic, Milovan Bojic, Dragan Milic and Slobodan Micovic
Medicina 2023, 59(2), 217; https://doi.org/10.3390/medicina59020217 - 23 Jan 2023
Cited by 5 | Viewed by 2564
Abstract
Background and Objectives: The saphenous vein is one of the most common used grafts (SVG) for surgical revascularization. The mechanism of the SVGs occlusion is still unknown. Surgical preparation techniques have an important role in the early and late graft occlusion. Our study [...] Read more.
Background and Objectives: The saphenous vein is one of the most common used grafts (SVG) for surgical revascularization. The mechanism of the SVGs occlusion is still unknown. Surgical preparation techniques have an important role in the early and late graft occlusion. Our study analyzed the influence of the three different surgical techniques on the histological and immunohistochemical characteristics of the vein grafts. Methods: Between June 2019 and December 2020, 83 patients who underwent surgical revascularization were prospectively randomly assigned to one of the three groups, according to saphenous vein graft harvesting (conventional (CVH), no-touch (NT) and endoscopic (EVH)) technique. The vein graft samples were sent on the histological (hematoxylin-eosin staining) and immunohistochemical (CD31, Factor VIII, Caveolin and eNOS) examinations. Results: The CVH, NT, and EVH groups included 27 patients (mean age 67.66 ± 5.6), 31 patients (mean age 66.5 ± 7.4) and 25 patients (mean age 66 ± 5.5), respectively. Hematoxylin-eosin staining revealed a lower grade of microstructural vein damage in the NT group (2, IQR 1-2) in comparison with CVH and EVH (3, IQR 2-4), (4, IQR 2-4) respectively (p < 0.001). Immunohistochemical examination revealed a high grade of staining in the NT group compared to the CVH and EVH group (CD 31 antibody p = 0.02, FVIII, p < 0.001, Caveolin, p = 0.001, and eNOS, p = 0.003). Conclusion: The best preservation of the structural vein integrity was in the NT group, while the lowest rate of leg wound complication was in the EVH group. These facts increase the interest in developing and implementing the endoscopic no-touch technique. Full article
(This article belongs to the Section Surgery)
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33 pages, 3829 KiB  
Article
FLISR Approach for Smart Distribution Networks Using E-Terra Software—A Case Study
by Duy Phuc Le, Duong Minh Bui, Cao Cuong Ngo and Anh My Thi Le
Energies 2018, 11(12), 3333; https://doi.org/10.3390/en11123333 - 29 Nov 2018
Cited by 30 | Viewed by 7751
Abstract
A smart grid concept has been defined in recent years, which emphasizes the importance on smart protection and measurement devices, reliable data communication and high security, optimal energy management system, and fault detection, location, isolation and service restoration (FLISR) of distribution networks (DNs). [...] Read more.
A smart grid concept has been defined in recent years, which emphasizes the importance on smart protection and measurement devices, reliable data communication and high security, optimal energy management system, and fault detection, location, isolation and service restoration (FLISR) of distribution networks (DNs). The main objectives of the FLISR approach are to achieve fast fault processing time, reduce the minimum number of interrupted customers, and improve the power supply reliability of the distribution. The conventional FLISR approach is to use signals of fault indicators (FIs) with distribution network states. The discrete installation of FIs to switches or reclosers may slow the processing time of fault detection and location, so it is necessary to develop a more efficient FLISR approach for smart distribution networks using functions of feeder terminal units (FTUs). In this paper, pick-up and tripping signals of overcurrent (OC) relays in combination with distribution grid states (e.g., switching status of devices, loss of voltage…) sent from feeder terminal units (FTUs) are used to detect and locate different fault types. Fault isolation and service restoration of black-out areas are then performed by solving an objective function with two main constraints, including (i) restoring the possible maximum number of out-of-service loads; and (ii) limiting the minimum number of switching operation. Thirteen performance factors (PF) are used for the post-fault service restoration process, consisting of: (i) Power Flow Violations (PFV), (ii) Bus Voltage Violations (BVV), (iii) Total Operation Cost (TOC), (iv) Lost Power (LP), (v) Outage Customer (OC), (vi) Number of Switching Steps (NSS), (vii) Power Losses (LOSS); (viii) Customer Minutes Interruption (CMI), (ix) Load Minutes Interruption (LMI), (x) MAIFI, (xi) SAIFI, (xii) SAIDI, and (xiii) Protection Validation (PRV). E-Terra platform of a distribution management system (DMS) is used to implement the proposed FLISR approach. Simulation and experiment results from a real 22 kV distribution network are also analysed to validate this FLISR approach. As a result, the novel FLISR approach has the ability to identify effectively the over-reaching of OC relays, indicate a mis-coordination risk of adjacent protection devices on the same feeder, and get the total processing time of fault detection, location and isolation as well as ranking all possible service restoration plans in distribution network at less than two minutes. Full article
(This article belongs to the Special Issue Operation and Control of Power Distribution Systems)
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11 pages, 2956 KiB  
Article
Anticoagulant Activities of Indobufen, an Antiplatelet Drug
by Jia Liu, Dan Xu, Nian Xia, Kai Hou, Shijie Chen, Yu Wang and Yunman Li
Molecules 2018, 23(6), 1452; https://doi.org/10.3390/molecules23061452 - 15 Jun 2018
Cited by 32 | Viewed by 6600
Abstract
Indobufen is a new generation of anti-platelet aggregation drug, but studies were not sufficient on its anticoagulant effects. In the present study, the anticoagulant activity of indobufen was determined by monitoring the activated partial thromboplastin time (APTT), prothrombin time (PT), and thrombin time [...] Read more.
Indobufen is a new generation of anti-platelet aggregation drug, but studies were not sufficient on its anticoagulant effects. In the present study, the anticoagulant activity of indobufen was determined by monitoring the activated partial thromboplastin time (APTT), prothrombin time (PT), and thrombin time (TT) in rabbit plasma. We evaluated the anticoagulant mechanisms on the content of the platelet factor 3,4 (PF3,4), and the coagulation factor 1, 2, 5, 8, 10 (FI, II, V, VIII, X) in rabbits, as well as the in vivo bleeding time and clotting time in mice. The pharmacodynamic differences between indobufen and warfarin sodium, rivaroxaban, and dabigatran were further studied on thrombus formation and the content of FII and FX in rats. Animal experiments showed that intragastric-administrated indobufen can significantly reduce the APTT, PT, TT, PF3, FI, II, V, VIII, and X plasma contents. Its inhibitory effect on plasma FII was better than thrombin inhibitor dabigatran with effect on FX better than FXa inhibitor rivaroxaban. These results suggest that indobufen has some anticoagulant effects as strong as some conventional anticoagulants. The mechanism may be related to both exogenous and endogenous coagulation system. Full article
(This article belongs to the Section Medicinal Chemistry)
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12 pages, 1203 KiB  
Article
Modeling of Body Weight Metrics for Effective and Cost-Efficient Conventional Factor VIII Dosing in Hemophilia A Prophylaxis
by Alanna McEneny-King, Pierre Chelle, Severine Henrard, Cedric Hermans, Alfonso Iorio and Andrea N. Edginton
Pharmaceutics 2017, 9(4), 47; https://doi.org/10.3390/pharmaceutics9040047 - 17 Oct 2017
Cited by 18 | Viewed by 5918
Abstract
The total body weight-based dosing strategy currently used in the prophylactic treatment of hemophilia A may not be appropriate for all populations. The assumptions that guide weight-based dosing are not valid in overweight and obese populations, resulting in overdosing and ineffective resource utilization. [...] Read more.
The total body weight-based dosing strategy currently used in the prophylactic treatment of hemophilia A may not be appropriate for all populations. The assumptions that guide weight-based dosing are not valid in overweight and obese populations, resulting in overdosing and ineffective resource utilization. We explored different weight metrics including lean body weight, ideal body weight, and adjusted body weight to determine an alternative dosing strategy that is both safe and resource-efficient in normal and overweight/obese adult patients. Using a validated population pharmacokinetic model, we simulated a variety of dosing regimens using different doses, weight metrics, and frequencies; we also investigated the implications of assuming various levels of endogenous factor production. Ideal body weight performed the best across all of the regimens explored, maintaining safety while moderating resource consumption for overweight and obese patients. Full article
(This article belongs to the Special Issue Pharmacokinetics and Drug Metabolism in Canada: The Current Landscape)
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