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

The objective of the study is to evaluate if FS Grifols is non-inferior to EVICEL® in terms of the percentage of participants achieving hemostasis at the target bleeding site (TBS) by 4 minutes (T4) from the start of treatment application (TStart) with no occurrence of rebleeding until the completion of the surgical closure by layers of the exposed surgical field containing the TBS (TClosure).

开始日期2019-01-18

申办/合作机构

Instituto Grifols SA

EUCTR2016-004489-24-BG

/ Unknown status临床3期

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.

开始日期2018-09-13

申办/合作机构

Instituto Grifols SA

EUCTR2016-004489-24-HU

/ Unknown status临床3期

开始日期2018-06-21

申办/合作机构

Instituto Grifols SA

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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项与纤维蛋白粘合剂（Grifols）相关的文献（医药）

2024-11-01·JOURNAL OF PEDIATRIC SURGERY

A Phase 3, Randomized, Active-controlled, Single-blind Clinical Trial to Evaluate the Efficacy of Fibrin Sealant Grifols in Achieving Hemostasis in Pediatric Surgery

Article

作者: Balanescu, Laura ; Slavkovic, Andjelka ; Camprubí, Sandra ; Hanna, Kim ; James, Michael K. ; Jenovari, Zoltan ; Querolt, Montse ; Gajdobranski, Djordje ; Mikickovic, Maja ; Bozzo, Jordi ; Vajda, Péter ; Camprubí, Sandra ; Kamenov, Krasimir ; Querolt, Montse ; Irtan, Sabine ; Mondou, Elsa ; Mondou, Elsa ; Kalinova, Krasimira ; Ninov, Borislav ; Sharif, Khalid ; Simeonov, Simeon ; Sretenović, Aleksandar ; Wiener, Isodoro ; Hanna, Kim

BACKGROUND:

In this study, two fibrin sealant products, Fibrin Sealant Grifols (FS Grifols 80 mg/mL fibrinogen; 500 IU/mL thrombin) and Evicel (fibrinogen 55-85 mg/mL; thrombin 800-1200 IU/mL) were studied for efficacy in achieving hemostasis at a targeted bleeding site (TBS) on parenchymous or soft tissue in pediatric surgeries.

METHODS:

This phase 3, single-blind, active comparator, non-inferiority trial compared the number of patients achieving hemostasis at a TBS at four (T₄ - primary endpoint), seven (T₇) and 10 (T₁₀) minutes after application, Safety and tolerability were assessed by recording adverse events during and after procedures. Eligible patients were <18 years old undergoing elective, open, non-cardiac thoracic, abdominal or pelvic surgeries. Preterm (<37 weeks gestation) and newborn (0-27 days) infants were eligible.

RESULTS:

At T₄, 98.7% of FS Grifols group (n = 91) and 95.4% of the Evicel group (n = 87) achieved hemostasis. All patients with residual bleeding at T₄ were undergoing soft tissue surgery. All patients achieved hemostasis by T₇. At T₁₀, all patients achieved hemostasis except one (FS Grifols (no observation recorded)). There were no incidents of persistent bleeding. For FS Grifols, 26.5% of patients had treatment-emergent adverse events (TEAEs) and 18.4% for Evicel. One TEAE (moderate procedural pain - FS Grifols group) was considered possibly related to study treatment. Three patients died for reasons unrelated to the study medications.

CONCLUSIONS:

FS Grifols was safe and effective at achieving hemostasis in pediatric patients having parenchymous or soft tissue surgeries. The efficacy of FS Grifols was non-inferior to Evicel.

LEVEL OF EVIDENCE:

2024-06-01·Cartilage

Mechanical Evaluation of Commercially Available Fibrin Sealants for Cartilage Repair

Article

作者: Amirhekmat, Arya ; Salinas, Evelia Y. ; Wang, Dean ; Hu, Jerry C. ; Brown, Wendy E. ; Athanasiou, Kyriacos A.

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.

2020-03-15·Journal of investigative surgery : the official journal of the Academy of Surgical Research4区 · 医学

A Prospective, Single-Blind, Randomized, Phase III Study to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols as an Adjunct to Hemostasis During Soft Tissue Open Surgery

4区 · 医学

Article

作者: Lakshman, Shankar ; Davis, Ronald ; Navarro-Puerto, Jordi ; Ibañez, Julia ; Stefanovic, Aleksandar ; Barrera, Gladis ; Djurdjevic, Srdjan ; Chen, Junliang ; Osváth, Péter ; Nyirády, Péter ; Bullock, Arnold ; Aqua, Keith

BACKGROUND/PURPOSE:

Rapid hemostasis, an essential prerequisite of good surgical practice during surgical bleeding, including soft tissue open surgery, often requires adjunctive treatment. We evaluated the safety and hemostatic effectiveness of a human plasma-derived fibrin sealant (FS Grifols) in soft tissue open surgery.

METHODS:

Patients with moderate soft tissue bleeding during open, urologic, gynecologic or general surgery were studied. The trial consisted of a preliminary phase (to familiarize investigators with the technique for FS Grifols application and the intraoperative procedures required by the clinical protocol) and a primary phase: in both phases, patients were randomized 1:1 to FS Grifols or Surgicel^®. The primary efficacy endpoint, based on analysis of subjects in the primary phase of the study, was to evaluate whether FS Grifols was non-inferior to Surgicel^® in achieving hemostasis, based on the proportion of subjects in both treatment groups who achieved hemostasis at the target bleeding site (TBS) by 4 min (T₄) following the start of treatment application. Safety assessments included adverse events (AEs), vital signs, physical assessments, common clinical laboratory tests, viral markers, and immunogenicity.

RESULTS:

A total of 224 subjects were randomized (primary phase): FS Grifols (N = 116), Surgicel^® (N = 108). The 95% CI at T₄ for the ratio of the proportion of patients achieving hemostasis in the two treatment groups was 1.064 (0.934, 1.213), indicating non-inferiority for FS Grifols vs. Surgicel^®. The rate of hemostasis at the TBS by T₄ in both phases of the study was higher in the FS Grifols treatment group (preliminary phase: 90.2%; primary phase: 82.8%) than in the Surgicel^® treatment group (preliminary phase: 78.8%; primary phase: 77.8%). Overall, reported AEs were as expected in surgical patients and were similar between the two treatment groups.

CONCLUSIONS:

This study shows the non-inferiority in time to hemostasis of FS Grifols vs. Surgicel as an adjunct to hemostasis in patients undergoing soft tissue open surgery, and a similar rate of AEs.

项与纤维蛋白粘合剂（Grifols）相关的新闻（医药）

2024-10-29

·GlobeNewswire-Health Care

Grifols Receives FDA Approval to Treat Surgical Bleeding in Pediatric Patients With its Fibrin Sealant Solution

Younger patients in the U.S. can now benefit from Grifols Fibrin Sealant (FS) and its positive effect on surgical outcomes, including a fast time to hemostasisGrifols surgical bleeding management treatments form part of an increasingly robust portfolio of innovative therapeutics enhancing the health and well-being of patients BARCELONA, Spain, Oct. 29, 2024 (GLOBE NEWSWIRE) -- Grifols (MCE:GRF, MCE:GRF.P, NASDAQ:GRFS), a global healthcare company and leading manufacturer of plasma-derived medicines, today announced that its plasma-protein based fibrin sealant (FS) for controlling surgical bleeding has received approval from the United States Food and Drug Administration (FDA) for pediatric patients. The U.S. indication for children and adolescents extends the availability of FS, which is already approved for this patient segment in Europe, in addition to adults. During surgery Grifols FS promotes hemostasis and tissue sealing, resulting in reduced blood loss and potentially fewer complications. Grifols FS biosurgery treatment is commercialized as VISTASEAL™ in the U.S. and Canada, and VERASEAL™ in Europe and elsewhere. Both brands are marketed and distributed by Johnson & Johnson MedTech, as part of a strategic collaboration between the two companies announced in 2019. Grifols FS combines two plasma proteins, fibrinogen and thrombin, and is applied with Johnson & Johnson MedTech’s airless spray technology to rapidly form clots. The FS solution is now available in 18 countries. In early 2023, Grifols announced that it had met all primary and secondary endpoints of its phase 3b study evaluating the administration of Grifols FS to pediatric patients, defined as those not having reached 18 years of age. Researchers conducted a global prospective, randomized, active-controlled, single-blind, parallel group clinical trial designed to evaluate the safety and efficacy of the FS as an adjunct to hemostasis during surgery in pediatric patients (compared with an active control). The study included a total of 178 patients enrolled and treated across 18 recruitment centers. A greater than 95% efficacy rate was achieved in both treatment arms, with hemostasis within four minutes of application. In addition, Grifols FS demonstrated a good safety and tolerability profile, as the distribution of adverse events was comparable between arms. “Developing innovative biosurgery solutions reflects Grifols’ ability to provide patients with more medicines across many therapeutic areas to enhance their well-being,” said Joerg Schuettrumpf, Grifols Chief Scientific Innovation Officer. It’s estimated that between roughly one-third and two-thirds of open surgeries experience disruptive bleeding,1 while challenging and uncontrollable bleeding during surgery is associated with high mortality rates.1,2 About VISTASEAL VISTASEAL is a single-use product that uses a combination of human fibrinogen and human thrombin to assist with mild to moderate bleeding control when standard surgical techniques such as suture or cautery are ineffective. The sealant is applied in a thin layer over the bleeding tissue in order to generate a cross-linked fibrin clot to achieve hemostasis. VISTASEAL can be utilized in high-risk patients when there are concerns regarding coagulopathy, antiplatelets, anticoagulants, and friable tissue. VISTASEAL™ Fibrin Sealant (Human) IMPORTANT SAFETY INFORMATION INDICATIONVISTASEAL™, a fibrin sealant, is indicated as an adjunct to hemostasis for mild to moderate bleeding in patients undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. VISTASEAL™ is effective in heparinized patients. CONTRAINDICATIONSDo not inject directly into the circulatory system. Do not use for the treatment of severe or brisk arterial bleeding.Do not use in patients with history of anaphylaxis or severe systemic reactions to human blood products.Do not use VISTASEAL™ for spraying unless the minimum recommended distance from the applicator tip to the bleeding site can be achieved. WARNINGS AND PRECAUTIONS Thromboembolic events may occur if VISTASEAL™ is administered intravascularly. Hypersensitivity reactions can occur. May carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. ADVERSE REACTIONSThe most common adverse reactions (reported in >1% of patients) were procedural pain, and nausea. For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert.MEDIA CONTACTS: Grifols Press Office media@grifols.comTel. +34 93 571 00 02 SpainDuomo ComunicaciónTel.: +34 91 311 92 89 – +34 91 311 92 90Raquel Lumbreras (Tel. +34 659 572 185)Raquel_lumbreras@duomocomunicacion.comBorja Gómez (Tel. + 34 659 572 185)Borja_gomez@duomocomunicacion.com InvestorsInvestors Relations & Sustainabilityinversores@grifols.com - investors@grifols.comTel. +34 93 571 02 21 About Grifols Grifols is a global healthcare company founded in Barcelona in 1909 committed to improving the health and well-being of people around the world. A leader in essential plasma-derived medicines and transfusion medicine, the company develops, produces, and provides innovative healthcare services and solutions in more than 110 countries. Patient needs and Grifols’ ever-growing knowledge of many chronic, rare and prevalent conditions, at times life-threatening, drive the company’s innovation in both plasma and other biopharmaceuticals. Grifols is focused on treating conditions across a broad range of therapeutic areas: immunology, hepatology and intensive care, pulmonology, hematology, neurology, and infectious diseases. A pioneer in the plasma industry, Grifols continues to grow its network of donation centers, the world’s largest with over 390 across North America, Europe, Africa and the Middle East, and China. As a recognized leader in transfusion medicine, Grifols offers a comprehensive portfolio of solutions designed to enhance safety from donation to transfusion, in addition to clinical diagnostic technologies. It provides high-quality biological supplies for life-science research, clinical trials, and for manufacturing pharmaceutical and diagnostic products. The company also supplies tools, information and services that enable hospitals, pharmacies and healthcare professionals to efficiently deliver expert medical care. Grifols, with more than 23,000 employees in more than 30 countries and regions, is committed to a sustainable business model that sets the standard for continuous innovation, quality, safety, and ethical leadership. The company’s class A shares are listed on the Spanish Stock Exchange, where they are part of the Ibex-35 (MCE:GRF). Grifols non-voting class B shares are listed on the Mercado Continuo (MCE:GRF.P) and on the U.S. NASDAQ through ADRs (NASDAQ:GRFS). For more information about Grifols, please visit grifols.com LEGAL DISCLAIMERThe facts and figures contained in this report that do not refer to historical data are “future projections and assumptions.” Words and expressions such as “believe,” “hope,” “anticipate,” “predict,” “expect,” “intend,” “should,” “will seek to achieve,” “it is estimated,” “future” and similar expressions, in so far as they relate to the Grifols group, are used to identify future projections and assumptions. These expressions reflect the assumptions, hypotheses, expectations and predictions of the management team at the time of writing this report, and these are subject to a number of factors that mean that the actual results may be materially different. The future results of the Grifols group could be affected by events relating to its own activities, such as a shortage of supplies of raw materials for the manufacture of its products, the appearance of competitor products on the market, or changes to the regulatory framework of the markets in which it operates, among others. At the date of compiling this report, the Grifols group has adopted the necessary measures to mitigate the potential impact of these events. Grifols, S.A. does not accept any obligation to publicly report, revise or update future projections or assumptions to adapt them to events or circumstances subsequent to the date of writing this report, except where expressly required by the applicable legislation. This document does not constitute an offer or invitation to buy or subscribe shares in accordance with the provisions of the following Spanish legislation: Royal Legislative Decree 4/2015, of 23 October, approving recast text of Securities Market Law; Royal Decree Law 5/2005, of 11 March and/or Royal Decree 1310/2005, of 4 November, and any regulations developing this legislation. In addition, this document does not constitute an offer of purchase, sale or exchange, or a request for an offer of purchase, sale or exchange of securities, or a request for any vote or approval in any other jurisdiction. The information included in this document has not been verified nor reviewed by the external auditors of the Grifols group. 1 Corral M, Ferko N, Hollmann S, Broder MS, Chang E. Health and economic outcomes associated with uncontrolled surgical bleeding: a retrospective analysis of the Premier Perspectives Database. Clinicoecon Outcomes Res. 2015;7:409-421. doi:10.2147/CEOR.S863692 Marietta M, Facchini L, Pedrazzi P, Busani S, Torelli G. Pathophysiology of bleeding in surgery. Transplant Proc. 2006;38(3):812-814. doi:10.1016/j.transproceed.2006.01.047

临床3期临床结果上市批准

2024-02-28

·Pharmaceutical Technology

Grifols prepares for late-stage plans with plasma-derived medicines in 2024

In an exclusive interview with Pharmaceutical Technology, Grifols declared plans for multiple Phase III readouts in 2024. Credit: Bloomberg via Getty Images Grifols plans to release Phase III results of its long-term albumin treatment designed to increase survival time in patients with decompensated cirrhosis and ascites in 2024, says chief scientific innovations officer Jorg Schüttrumpf. Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success. 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Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Thank you. You will receive an email shortly. Please check for download the Report. Related Company Profiles Grifols SA Ethicon US LLC Johnson & Johnson Biotest AG View all In an exclusive interview with Pharmaceutical Technology, Schüttrumpf outlined the plasma derived-medicines company’s 2024 goals for its late-stage candidates as several trials come to a head. The aforementioned Preciosa trial (NCT03451292) studying human albumin is focused on patients awaiting a suitable transplant. Grifols also plans to release data from its Phase III ESsCAPE study (NCT05722938), investigating trimodulin, triple action immunoglobulin with IgM, IgA and IgG, at some point this year. In February, the company reported positive efficacy results from a trial investigating Grifols’ fibrinogen concentrate (FC), BT524, for the treatment of acquired fibrinogen deficiency (AFD). The company now plans to complete European Medicines Agency (EMA) and US Food and Drug Administration (FDA) regulatory submissions, in pursuit of approval. “We are working with different partners. In the immunology, and pulmonary disease space, to support their growth,” says Schüttrumpf. Additionally, the Spain-headquartered company is exploring partnerships similar to the one it has with Ethicon, says Schüttrumpf. Grifols began its collaboration with Ethicon, a subsidiary of Johnson & Johnson , in 2017, wherein Grifols agreed to exclusively manufacture and supply plasma-derived products for use in the biosurgery field for 10 years. See Also: Pelage secures funds to develop regenerative medicine for hair loss Praxis Precision Medicines sees highest patent filings and grants during November in Q4 2023 In 2021, Grifols announced the acquisition of Tiancheng (Germany) Pharmaceutical Holding s, which owned 89.88% of another plasma products specialist Biotest . Grifols is developing trimodulin and B524 with Biotest. Before the acquisition, Grifols had already explored fibrinogen concentrate for the development of Vistaseal (fibrinogen (human) + thrombin (human), commercialised as Veraseal in Europe. Schüttrumpf highlights Grifol’s ability to complete in-house manufacturing for plasma-derived therapeutics like BT524. He said that this gave the company a major advantage in its operations, also allowing it to offer its manufacturing services to other pharmaceutical companies. Grifols has plans to release its 2023 annual financial report on 29 February. 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临床3期并购临床结果

2023-12-25

·SYNAPSE

Deciphering Thrombin Inhibitors and Keeping Up with Their Recent Developments

Thrombin is a crucial enzyme in the human body that plays a vital role in the blood clotting process, known as coagulation. It is produced from its precursor, prothrombin, and is activated in response to injury or damage to blood vessels. Thrombin acts as a catalyst in the conversion of fibrinogen to fibrin, forming a mesh-like structure that helps in the formation of blood clots to prevent excessive bleeding. Additionally, thrombin also activates other factors involved in the coagulation cascade, amplifying the clotting response. Its precise regulation is essential to maintain the delicate balance between clot formation and prevention of unwanted clotting within the body. The development of thrombin inhibitors has been a significant advancement in the field of medicine. The first direct thrombin inhibitor (DTI) was hirudin, which became more easily available with genetic engineering. DTIs have undergone rapid development since the 90s. Before the use of DTIs, the therapy and prophylaxis for anticoagulation had stayed the same for over 50 years with the use of heparin derivatives and warfarin. The analysis of the current competitive landscape and future development of target thrombin reveals several key findings. Grifols SA, China National Pharmaceutical Group Co., Ltd., and Hualan Biological Engineering, Inc. are among the companies growing fastest under this target, with Grifols SA having the highest stage of development. Hemorrhage is the most common indication for approved drugs, followed by indications such as hemophilia B, thrombosis, and venous thromboembolism. Non-recombinant coagulation factors are progressing rapidly, indicating intense competition around innovative drugs. China is developing rapidly under this target, with the highest number of approved drugs. However, further research and development are needed to explore the potential of inactive drugs in various countries/locations. Overall, the target thrombin presents opportunities for companies and researchers to develop effective treatments for various indications related to blood clotting disorders. How do they work?Thrombin inhibitors are a type of medication that specifically target and inhibit the activity of thrombin, which is a key enzyme involved in blood clotting. Thrombin is responsible for converting fibrinogen into fibrin, which forms a mesh-like structure to help stop bleeding by forming blood clots. However, excessive or inappropriate blood clotting can lead to serious conditions such as deep vein thrombosis, pulmonary embolism, or stroke. Thrombin inhibitors work by binding to thrombin and preventing its enzymatic activity, thereby reducing the formation of blood clots. They can be classified into two main types: direct thrombin inhibitors and indirect thrombin inhibitors. Direct thrombin inhibitors directly bind to and inhibit the active site of thrombin, preventing its ability to convert fibrinogen into fibrin. Examples of direct thrombin inhibitors include dabigatran and argatroban. Indirect thrombin inhibitors, on the other hand, work by targeting other molecules in the blood clotting cascade to indirectly inhibit thrombin activity. One example of an indirect thrombin inhibitor is heparin, which enhances the activity of antithrombin III, a natural inhibitor of thrombin. Thrombin inhibitors are commonly used in the prevention and treatment of various thrombotic disorders, such as deep vein thrombosis, atrial fibrillation, and pulmonary embolism. They can also be used during certain surgical procedures to reduce the risk of blood clots. However, it is important to closely monitor patients receiving thrombin inhibitors, as they can increase the risk of bleeding. List of thrombin InhibitorsThe currently marketed thrombin inhibitors include: Human prothrombin complex (Guangdong Shuanglin)Human prothrombin complex (Tonrol)Human prothrombin complex (Chengdu Rongsheng)Human prothrombin complex (Boya Bio)Human Prothrombin Complex (Guangdong Wellen Biological Pharmaceutical)Human prothrombin complex(Sinopharm Group Shanghai Blood Products)Human Antithrombin III(Hemarus Therapeutics Ltd.)Human prothrombin complex(CSL bering)Human prothrombin complex(LFB Biotechnologies SASU)Human Prothrombin Complex(Harbin Pacific Biopharmaceutical)For more information, please click on the image below. What are thrombin inhibitors used for?Thrombin inhibitors are commonly used in the prevention and treatment of various thrombotic disorders, such as deep vein thrombosis, atrial fibrillation, and pulmonary embolism. For more information, please click on the image below to log in and search. How to obtain the latest development progress of thrombin inhibitors?In the Synapse database, you can keep abreast of the latest research and development advances of thrombin inhibitors anywhere and anytime, daily or weekly, through the "Set Alert" function. Click on the image below to embark on a brand new journey of drug discovery!

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

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
凝血障碍	欧盟	Instituto Grifols SA	2017-11-10
凝血障碍	冰岛	Instituto Grifols SA	2017-11-10
凝血障碍	列支敦士登	Instituto Grifols SA	2017-11-10
凝血障碍	挪威	Instituto Grifols SA	2017-11-10
出血	美国	Instituto Grifols SA	2017-11-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03461406 (CTgov)	临床3期	出血	186	Fibrin Sealant Grifols (Fibrin Sealant Grifols)	簾糧製憲鏇範鹹醖範獵 = 範鏇壓獵獵襯鹽鏇鏇築淵醖窪憲憲觸鏇淵壓窪 (鑰糧衊範遞築鑰鏇鹹糧, 顧膚襯衊餘艱繭夢構醖 ~ 積餘顧鑰憲選鬱構積願) 更多	-	2023-04-07
				EVICEL (EVICEL)	簾糧製憲鏇範鹹醖範獵 = 壓糧膚鑰積壓繭糧積壓淵醖窪憲憲觸鏇淵壓窪 (鑰糧衊範遞築鑰鏇鹹糧, 顧襯築鬱壓繭鏇廠鬱膚 ~ 齋壓獵壓製糧衊範夢鹽) 更多
NCT01662856 (CTgov)	临床3期	出血	225	Fibrin Sealant Grifols (Fibrin Sealant Grifols)	鹽醖願鬱廠構淵積憲鏇 = 衊襯鏇鹽範製窪壓選夢鹹壓廠蓋鹹鹹願鏇積淵 (鹽簾廠鏇醖鏇繭醖糧構, 觸鹹蓋憲淵鹽願顧製網 ~ 淵醖築艱醖構顧夢觸壓) 更多	-	2017-04-06
				Manual Compression (Manual Compression)	鹽醖願鬱廠構淵積憲鏇 = 蓋壓廠餘簾蓋築夢鹹鬱鹹壓廠蓋鹹鹹願鏇積淵 (鹽簾廠鏇醖鏇繭醖糧構, 蓋壓餘網鬱憲觸構築夢 ~ 積膚築簾淵遞簾壓齋艱) 更多
NCT01731938 (CTgov)	临床3期	出血	327	Fibrin Sealant (FS) Grifols (Fibrin Sealant (FS) Grifols)	鏇淵網繭衊壓夢網壓願 = 壓膚鏇鬱醖鏇願築鑰願鑰壓憲蓋顧築築艱憲觸 (蓋糧積簾範鏇衊網積糧, 襯鬱廠膚艱蓋廠齋鹽選 ~ 網築蓋鏇醖簾觸蓋簾廠) 更多	-	2017-02-23
				Surgicel® (Surgicel®)	鏇淵網繭衊壓夢網壓願 = 鹽壓願糧製顧範遞襯壓鑰壓憲蓋顧築築艱憲觸 (蓋糧積簾範鏇衊網積糧, 鹽觸餘構築膚衊襯築衊 ~ 鑰壓淵選選衊淵憲顧積) 更多
NCT01754480 (CTgov)	临床3期	出血	325	Fibrin Sealant Grifols (Fibrin Sealant Grifols)	遞範夢鏇顧蓋膚鹹構襯 = 醖顧窪積簾選廠觸壓簾簾艱餘構鹹獵網餘願夢 (齋齋衊獵積願網簾鬱壓, 襯獵鏇膚夢襯膚獵獵製 ~ 鏇鬱構觸鬱鹽夢觸蓋繭) 更多	-	2017-02-08
				Surgicel® (Surgicel®)	遞範夢鏇顧蓋膚鹹構襯 = 願衊齋網糧顧遞淵範餘簾艱餘構鹹獵網餘願夢 (齋齋衊獵積願網簾鬱壓, 夢繭積願鑰製襯膚襯顧 ~ 餘顧糧憲蓋淵壓膚醖積) 更多
NCT00684047 (CTgov)	临床2/3期	出血	239	FS Grifols (FS Grifols Primary Part (II))	築簾繭積顧窪簾構糧窪 = 憲獵顧壓築遞廠鏇淵鏇網構糧選築簾簾鏇構獵 (網淵遞醖鬱窪膚糧遞製, 繭鑰夢淵觸觸積鬱鑰願 ~ 構鏇衊繭觸積醖網築衊) 更多	-	2016-01-25
				Manual Compression (Manual Compression Primary Part (II))	築簾繭積顧窪簾構糧窪 = 繭餘積遞鹹鹹顧鏇繭鏇網構糧選築簾簾鏇構獵 (網淵遞醖鬱窪膚糧遞製, 齋鏇顧齋築網鬱鏇遞窪 ~ 願襯願蓋顧襯鏇積願鏇) 更多