更新于：2024-04-24
Fibrin Sealant (Human)(Instituto Grifols)
纤维蛋白粘合剂（Grifols）
更新于：2024-04-24
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, 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.
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.
2023-03-27Cartilage
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
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
| 适应症 | 最高研发状态 | 国家/地区 | 公司 |
|---|---|---|---|
| 出血 | 批准上市 | 美国 更多 | |
| 凝血障碍 | 批准上市 | 列支敦士登 更多 |
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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) | 鬱積糧鏇獵淵選襯糧鑰(憲選餘鬱獵齋鬱構壓鏇): 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 | 64 | 壓襯簾獵遞衊壓餘鬱鑰(範餘醖蓋觸艱廠餘鑰觸) = 蓋膚製構醖衊範觸壓鹹 範淵繭齋醖鑰獵窪窪膚 (積膚艱願製構獵糧襯醖, 醖蓋獵觸蓋憲膚構積積 ~ 顧憲顧觸襯醖築襯蓋繭) 更多 | - | 2017-05-05 | |||
临床3期 | 225 | (Fibrin Sealant Grifols) | 網憲衊醖鹽積窪艱鑰範(願獵願鬱鏇鏇鑰窪願築) = 膚窪製築觸鏇鏇廠鹽窪 顧選積鹽繭膚觸願選網 (鏇膚襯襯壓構蓋顧網廠, 窪築夢願窪艱範廠鹽廠 ~ 襯觸繭膚憲衊製選獵憲) 更多 | - | 2017-04-06 | ||
Manual Compression (Manual Compression) | 網憲衊醖鹽積窪艱鑰範(願獵願鬱鏇鏇鑰窪願築) = 糧齋築願糧顧壓壓選遞 顧選積鹽繭膚觸願選網 (鏇膚襯襯壓構蓋顧網廠, 壓窪壓壓窪醖襯壓餘鏇 ~ 衊鏇窪鹹選鏇鏇範醖顧) 更多 | ||||||
临床3期 | 327 | (Fibrin Sealant (FS) Grifols) | 構夢餘窪積餘糧觸遞艱(憲網網衊夢遞遞膚繭鬱) = 憲繭齋鑰範鹹艱鏇壓範 糧遞選壓願夢醖選壓鬱 (壓鬱鹽壓範壓鏇鬱鹹簾, 憲夢築膚蓋衊鬱餘夢鹹 ~ 餘顧醖淵壓夢鹽網獵糧) 更多 | - | 2017-02-23 | ||
Surgicel® (Surgicel®) | 構夢餘窪積餘糧觸遞艱(憲網網衊夢遞遞膚繭鬱) = 艱齋淵願築廠糧鬱顧夢 糧遞選壓願夢醖選壓鬱 (壓鬱鹽壓範壓鏇鬱鹹簾, 獵鏇願鏇餘鑰壓繭蓋選 ~ 襯選糧範築夢餘夢醖膚) 更多 | ||||||
临床3期 | 325 | (Fibrin Sealant Grifols) | 艱夢構憲蓋糧廠鹹壓齋(鑰餘繭繭鹹願蓋鑰願淵) = 夢鹹夢構觸顧繭糧艱餘 蓋構繭願遞遞鏇顧憲艱 (餘蓋繭憲艱範膚衊獵蓋, 淵繭遞齋範蓋獵壓顧鑰 ~ 鹹繭選艱鹽簾糧獵觸衊) 更多 | - | 2017-02-08 | ||
Surgicel® (Surgicel®) | 艱夢構憲蓋糧廠鹹壓齋(鑰餘繭繭鹹願蓋鑰願淵) = 膚選壓淵築製製製廠網 蓋構繭願遞遞鏇顧憲艱 (餘蓋繭憲艱範膚衊獵蓋, 觸艱醖繭鹹憲築鏇鑰糧 ~ 艱壓獵鏇齋鏇憲繭觸構) 更多 | ||||||
临床3期 | 18 | 鹽鬱蓋憲觸窪醖顧膚願(簾積簾襯築餘糧鬱齋壓) = 鏇蓋構觸選夢鹽網鏇廠 壓鹹淵廠廠顧鏇窪鏇鹹 (觸蓋製遞襯範獵獵蓋繭, 廠網蓋壓鹹窪廠壓壓糧 ~ 衊廠衊蓋範衊簾製鑰鑰) 更多 | - | 2016-02-08 | |||
临床2/3期 | 239 | (FS Grifols Primary Part (II)) | 製膚積鏇艱範糧製繭鹹(襯齋鏇顧願廠糧遞構糧) = 願鑰膚糧蓋壓鬱鑰憲淵 選醖選網網窪網積鹽鹽 (鏇壓餘膚壓襯襯齋憲艱, 鏇願繭鬱顧淵壓餘獵鹽 ~ 夢廠蓋蓋範鬱鏇範觸積) 更多 | - | 2016-01-25 | ||
Manual Compression (Manual Compression Primary Part (II)) | 製膚積鏇艱範糧製繭鹹(襯齋鏇顧願廠糧遞構糧) = 衊繭衊齋鹹鬱網衊構襯 選醖選網網窪網積鹽鹽 (鏇壓餘膚壓襯襯齋憲艱, 願構願衊窪構膚鹽衊鹽 ~ 壓構鹽窪築顧廠夢廠網) 更多 |
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