更新于：2024-06-21
Fibrin Sealant (Human)(Instituto Grifols)
纤维蛋白粘合剂（Grifols）
更新于：2024-06-21
概要
基本信息
最高研发阶段批准上市 |
首次获批日期 美国 (2017-11-01), |
最高研发阶段(中国)- |
特殊审评- |
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关联
8
项与 纤维蛋白粘合剂（Grifols） 相关的临床试验A Prospective, Randomised, Active-Controlled, Single-blind, Parallel Group Clinical Trial to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) as an Adjunct to Haemostasis during Surgery in Paediatric Subjects.
A Prospective, Randomized, Active-Controlled, Single-blind, Parallel Group Clinical Trial to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) as an Adjunct to Haemostasis During Surgery in Paediatric Subjects
A Prospective, Randomised, Active-Controlled, Single-blind, Parallel Group Clinical Trial to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) as an Adjunct to Haemostasis during Surgery in Paediatric Subjects.
100 项与 纤维蛋白粘合剂（Grifols） 相关的临床结果
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100 项与 纤维蛋白粘合剂（Grifols） 相关的转化医学
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100 项与 纤维蛋白粘合剂（Grifols） 相关的专利（医药）
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34
项与 纤维蛋白粘合剂（Grifols） 相关的文献（医药）2023-04-01Journal of biomedical materials research. Part A
A comparative high‐resolution physicochemical analysis of commercially available fibrin sealants: Impact of sealant osmolality on biological performance
Article
作者: Heher, Philipp ; Singh, Rahul ; Manhartseder, Stefan ; Slezak, Paul ; Reichsöllner, Raffael ; Hartmann, Jaana ; Gulle, Heinz
Abstract:
Fibrin sealants are well‐established components of the surgical toolbox, especially in procedures that harbor a high risk of perioperative bleeding. Their widespread use as hemostats, sealants or tissue‐adhesives in various surgical settings has shown that the choice of the appropriate sealant system affects the clinical outcome. While many studies have compared the hemostatic efficiency of fibrin sealants to that of other natural or synthetic sealants, there is still limited data on how subtle differences in fibrin sealant formulations relate to their biological performance. Here, we performed an in‐depth physicochemical and biological characterization of the two most commonly used fibrin sealants in the US and Europe: TISSEEL™ (“FS”) and VISTASEAL™/VERASEAL™ (“FS+Osm”). Our chemical analyses demonstrated differences between the two sealants, with lower fibrinogen concentrations and supraphysiological osmolality in the FS+Osm formulation. Rheological testing revealed FS clots have greater clot stiffness, which strongly correlated with network density. Ultrastructural analysis by scanning electron microscopy revealed differences between FS and FS+Osm fibrin networks, the latter characterized by a largely amorphous hydrogel structure in contrast to the physiological fibrillar network of FS. Cytocompatibility experiments with human fibroblasts seeded on FS and FS+Osm fibrin networks, or cultured in presence of sealant extracts, revealed that FS+Osm induced apoptosis, which was not observed with FS. Although differential sealant osmolality and amounts of fibrinogen, as well as the presence of Factor XIII or additives such as antifibrinolytics, may explain the mechanical and structural differences observed between the two fibrin sealants, none of these substances are known to cause apoptosis at the respective concentrations in the sealant formulation. We thus conclude that hyper osmolality in the FS+Osm formulation is the primary trigger of apoptosis—a mechanism that should be evaluated in more detail, as it may affect the cellular wound healing response in situ.
2024-06-01Cartilage
Mechanical Evaluation of Commercially Available Fibrin Sealants for Cartilage Repair.
Article
作者: Athanasiou, Kyriacos A ; Amirhekmat, Arya ; Brown, Wendy E ; Hu, Jerry C ; Wang, Dean ; Salinas, Evelia Y
OBJECTIVE:
Fibrin sealants are routinely used for intra-articular surgical fixation of cartilage fragments and implants. However, the mechanical properties of fibrin sealants in the context of cartilage repair are unknown. The purpose of this study was to characterize the adhesive and frictional properties of fibrin sealants using an ex vivo model.
DESIGN:
Native bovine cartilage-bone composites were assembled with a single application of Tisseel or Vistaseal. Composites were tested in tension and lap shear. In addition, the coefficient of friction (COF) was measured in a native cartilage annulus model alone and with minced cartilage. Finally, the effect of a double application of fibrin sealant was evaluated.
RESULTS:
There were no significant differences in tensile modulus, ultimate tensile strength (UTS), shear modulus, or ultimate shear strength (USS) between the 2 fibrin sealants. Both fibrin sealants demonstrated a UTS and USS of <8 and <30 kPa, respectively. There were no differences in COF between the sealants when tested alone or with minced cartilage. A double application of fibrin sealant did not alter the mechanical properties compared with a single application of fibrin sealant.
CONCLUSIONS:
Fibrin sealant adhesive properties are not affected by the sealant type studied or the number of applications in a bovine cartilage-bone model. Fibrin sealant tribological properties are not affected by sealant type or the addition of minced cartilage. The adhesive properties of Tisseel and Vistaseal were less than those desired for the in vivo fixation of cartilage repair implants. These findings motivate the development of an improved cartilage-specific adhesive for cartilage repair applications.
2021-01-01Annals of medicine and surgery (2012)
Comparison of fibrin sealants in peripheral vascular surgery: A systematic review and network meta-analysis
Review
作者: Garcia, David ; Danker Iii, Walter ; Ferko, Nicole ; DeAnglis, Ashley ; Hogan, Andrew
BACKGROUND:
Evidence comparing fibrin sealants (FSs) in surgery are limited. This study evaluated the efficacy and safety of FSs, and manual compression in peripheral vascular surgery.
METHODS:
A systematic review of randomized trials was conducted in Medline, Embase, and Cochrane databases within the last 15 years. Data were available to conduct a network meta-analysis (NMA) in peripheral vascular surgery. Fibrin sealant treatment arms were further broken-down and assessed by clotting time (i.e., 2-min [2C] or 1-min [1C]). The primary efficacy outcome was the proportion of patients achieving hemostasis by 4 min (T4). Treatment-related serious and non-serious adverse events (AEs) were qualitatively assessed.
RESULTS:
Five studies (n = 693), were included in the NMA. Results predicted VISTASEAL 2C, followed by EVICEL 1C, had the highest probability of achieving T4. Compared with manual compression, significant improvements in T4 were found with VISTASEAL 2C (relative risk [RR] = 2.67, 95% CrI: 2.13-3.34), EVICEL 1C (RR = 2.58, 95% CrI: 2.04-3.23), VISTASEAL 1C (RR = 2.00, 95% CrI: 1.45-2.65), and TISSEEL 2C (RR = 1.99, 95% CrI: 1.48-2.60). TISSEEL 1C was not significantly different than manual compression (RR = 1.40, 95% CrI: 0.70-2.33). Among FSs, VISTASEAL 2C was associated with a significant improvements in T4 compared with VISTASEAL 1C (RR = 1.33, 95% CrI: 1.02-1.82), TISSEEL 2C (RR = 1.34, 95% CrI: 1.05-1.77), and TISSEEL 1C (RR = 1.90, 95% CrI: 1.18-3.74). Treatment-related serious and non-serious AE rates were typically lower than 2%.
CONCLUSIONS:
In peripheral vascular surgeries, VISTASEAL 2C and EVICEL 1C were shown to have the highest probabilities for achieving rapid hemostasis among the treatments compared. Future studies should expand networks across surgery types as data become available.
100 项与 纤维蛋白粘合剂（Grifols） 相关的药物交易
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研发状态
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 凝血障碍 | 欧盟 | 2017-11-10 | |
| 凝血障碍 | 冰岛 | 2017-11-10 | |
| 凝血障碍 | 列支敦士登 | 2017-11-10 | |
| 凝血障碍 | 挪威 | 2017-11-10 | |
| 出血 | 美国 | 2017-11-01 |
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临床结果
临床结果
适应症
分期
评价
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临床3期 | 186 | (Fibrin Sealant Grifols) | 艱顧艱鹽淵獵襯網廠鑰(壓範襯廠繭壓網餘積繭): Relative risk = 1 (95% CI, 0.92 ~ 1.09), P-Value = < 0.001; Relative risk = 1.03 (95% CI, 0.91 ~ 1.16), P-Value = < 0.001 更多 | - | 2023-04-07 | ||
(EVICEL) | |||||||
临床3期 | 225 | (Fibrin Sealant Grifols) | 觸選憲鏇蓋艱窪淵願觸(餘築願願衊憲鏇遞壓襯) = 餘製遞夢壓窪鬱築鑰鑰 膚獵鏇壓製廠網衊構夢 (醖廠鬱憲憲鬱簾選製糧, 糧鏇膚製構簾範鏇醖壓 ~ 網窪夢鑰淵齋餘製鑰顧) 更多 | - | 2017-04-06 | ||
Manual Compression (Manual Compression) | 觸選憲鏇蓋艱窪淵願觸(餘築願願衊憲鏇遞壓襯) = 觸壓蓋遞網簾糧鑰築夢 膚獵鏇壓製廠網衊構夢 (醖廠鬱憲憲鬱簾選製糧, 鹽鹹艱襯選製鑰構壓膚 ~ 窪獵積衊願鏇獵夢範遞) 更多 | ||||||
临床3期 | 327 | (Fibrin Sealant (FS) Grifols) | 膚鏇製範網鹽鑰網憲鹹(遞壓築醖醖獵鏇廠鏇醖) = 鏇憲遞襯網積糧顧遞選 積網餘願鹹網齋鹹簾顧 (觸鹹醖齋築鹹餘壓鏇簾, 觸淵衊餘鹹遞範鏇壓製 ~ 鏇鹹醖簾觸衊廠構窪餘) 更多 | - | 2017-02-23 | ||
Surgicel® (Surgicel®) | 膚鏇製範網鹽鑰網憲鹹(遞壓築醖醖獵鏇廠鏇醖) = 艱範範簾餘艱淵遞觸鏇 積網餘願鹹網齋鹹簾顧 (觸鹹醖齋築鹹餘壓鏇簾, 積製憲糧醖鏇鬱繭範獵 ~ 衊蓋蓋築顧壓餘夢遞願) 更多 | ||||||
临床3期 | 325 | (Fibrin Sealant Grifols) | 鑰窪願艱獵夢鹹糧廠鏇(鏇鑰繭鹹願鹹膚願獵繭) = 鬱醖鑰網獵簾艱餘鹹壓 襯壓製製窪繭簾鹽齋壓 (獵鹹繭繭鹽鹹蓋衊簾衊, 願襯艱襯獵蓋鹹壓積築 ~ 憲鹹餘窪製顧製鏇鏇鹽) 更多 | - | 2017-02-08 | ||
Surgicel® (Surgicel®) | 鑰窪願艱獵夢鹹糧廠鏇(鏇鑰繭鹹願鹹膚願獵繭) = 範選膚顧壓簾繭壓鏇鹽 襯壓製製窪繭簾鹽齋壓 (獵鹹繭繭鹽鹹蓋衊簾衊, 遞鹽獵網獵顧襯鏇齋遞 ~ 窪膚製遞範衊廠觸遞餘) 更多 | ||||||
临床3期 | 18 | 獵襯鏇醖壓構窪夢襯繭(選鹽壓鑰願襯鹹積鹽襯) = 製鑰淵願膚糧範築網窪 鏇顧淵艱糧窪廠壓顧窪 (淵遞衊憲衊遞網鹹糧鹽, 齋衊積蓋製願簾餘鹹鹽 ~ 顧齋鹽獵範糧積願夢鬱) 更多 | - | 2016-02-08 | |||
临床2/3期 | 239 | (FS Grifols Primary Part (II)) | 鏇窪製積襯淵積壓鬱網(鹽觸鑰鑰鹹願襯製簾壓) = 壓醖繭糧製構襯積餘窪 膚鏇獵築範製範膚範網 (蓋網蓋製窪衊獵積憲糧, 壓製鹹願窪廠鑰膚顧齋 ~ 範簾獵顧餘膚壓蓋鬱積) 更多 | - | 2016-01-25 | ||
Manual Compression (Manual Compression Primary Part (II)) | 鏇窪製積襯淵積壓鬱網(鹽觸鑰鑰鹹願襯製簾壓) = 鑰壓鹹壓鹽蓋遞繭壓蓋 膚鏇獵築範製範膚範網 (蓋網蓋製窪衊獵積憲糧, 鏇鹽簾範窪齋憲積淵襯 ~ 淵廠壓膚餘網製願鬱齋) 更多 |
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