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

Lakshman, Shankar; Aqua, Keith; Stefanović, Aleksandar; Djurdjevic, Srdjan; Nyírády, Péter; Osváth, Péter; Davis, Ronald L.; Bullock, Arnold; Chen, Junliang; Ibanez, J Julian; Barrera, Gladis; Navarro-Puerto, Jordi

doi:10.1080/08941939.2018.1489917

Cited by 7 publications

(10 citation statements)

References 25 publications

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“…Fibrin Sealant Grifols with a ratio of 6 IU thrombin/mg fibrinogen has demonstrated efficacy in clinical studies in cardiovascular, liver, and soft tissue surgeries. [17][18][19][20] If compared with other marketed fibrin sealants (Table 5). The ratio of thrombin/fibrinogen for Fibrin Sealant Grifols is in the range (3-15 IU thrombin/ mg fibrinogen) of other marketed fibrin sealants.…”

Section: Discussionmentioning

confidence: 99%

Characterization of the Components and Functional Properties of a Plasma-Derived Fibrin Sealant

Ramaiola,

Lopez,

Moron

et al. 2023

Clin Med�Insights�Blood�Disord

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Background The activity and purity of Fibrin Sealant Grifols are described in this article. This fibrin sealant contains two components (fibrinogen and thrombin) that mimic the final stages of clotting. Fibrin sealants are primarily used as an adjunct to hemostasis for mild to moderate surgical bleeding in adults when standard surgical techniques are ineffective or impractical. Objective The aim of these studies was to assess the biochemical and functional characteristics of Fibrin Sealant Grifols. Methods Total protein, plasma protein impurities, and molecular forms were analyzed for both components. Clottable fibrinogen and thrombin activity were also measured. Both components were analyzed by SDS-PAGE and Western blot. The fibrin sealant clot was functionally characterized. Results The components had minimal contamination by other plasma proteins and no aggregates or degradation products. The fibrinogen component was almost completely clottable fibrinogen. The thrombin component contains albumin. The fibrinogen component formed a fibrin polymer and clots with tensile strength similar to literature values. The application device applied the components in a 1:1 volume ratio. Clotting time was ∼ 5 s when applied with the drip tip and nearly instantaneous when applied with the airless spray apparatus. Conclusion This fibrin sealant was shown to contain highly purified fibrinogen and thrombin delivered in a 1:1 volume ratio. These properties contribute to the clinical safety and efficacy of this product for many applications.

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Section: Discussionmentioning

confidence: 99%

Characterization of the Components and Functional Properties of a Plasma-Derived Fibrin Sealant

Ramaiola,

Lopez,

Moron

et al. 2023

Clin Med�Insights�Blood�Disord

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“…More recently, Fibrin Sealant Grifols (FS Grifols), a liquid HA composed of purified frozen solutions of human thrombin and human fibrinogen with calcium chloride, was launched. The efficiency and safety of FS Grifols as hemostatic aid in soft tissues surgeries was recently evaluated by comparison with the widely used Surgicel®, where promising results regarding the safety and hemostatic efficiency were obtained (Lakshman, Aqua, Stefanovic, et al, 2018). Moreover, a clinical trial is under development, with the aim to evaluate the hemostatic potential of FS Grifols in comparison with another fibrin sealant, EVICEL®, in pediatric patients (http://ClinicalTrials.gov identifier: NCT03461406; Grifols Therapeutics LLC, 2020).…”

Section: Has and Their Mechanisms Of Actionmentioning

confidence: 99%

Use of hemostatic agents for surgical bleeding in laparoscopic partial nephrectomy: Biomaterials perspective

et al. 2020

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In recent years, there was an abrupt increase in the incidence of renal tumors, which prompt up the appearance of cutting-edge technology, including minimally invasive and organ-preserving approaches, such as laparoscopic partial nephrectomy (LPN). LPN is an innovative technique used to treat small renal masses that have been gaining popularity in the last few decades due to its promissory results. However, the bleeding control remains the main challenge since the majority of currently available hemostatic agents (HAs) used in other surgical specialities are inefficient in LPN. This hurried the search for effective HAs adapted for LPN surgical peculiarities, which resulted on the emergence of different types of topical HAs. The most promising are the natural origin HAs because of their inherent biodegradability, biocompatibility, and lowest toxicity. These properties turn them top interests' candidates as HAs in LPN. In this review, we present a deep overview on the progress achieved in the design of HAs based on natural origin polymers, highlighting their distinguishable characteristics and providing a clear understanding of their hemostat's role in LPN. This way it may be possible to establish a structure-composition properties relation, so that novel HAs for LPN can be designed to explore current unmet medical needs. K E Y W O R D S biodegradable hemostatic agents, hemostasis, laparoscopic partial nephrectomy, minimally invasive surgeries, renal cell carcinoma 1 | BACKGROUND Kidney cancer is a serious condition, in accordance with the International Agency for Research on Cancer (IARC) it is the 16th most common cause of cancer death and the prevalence has been increasing every year, making kidney cancer considered as a clinically signifi

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“…Surgical bleeding is a common complication in almost all forms of surgeries, and prompt bleeding control and appropriate hemostasis are vital for successful operation and to prevent complications, such as hematomas or excessive bleeding that can endanger the patient’s life 1 , 2 , 3 . Surgical bleeding can cause higher infection rates and ventilator use and prolong hospitalization and operative time 4 , 5 , 6 causing considerable clinical and financial burdens 4 , 7 , 8 .…”

Section: Introductionmentioning

confidence: 99%

“…The standard techniques of bleeding control include mechanical compression, suturing, and electrocautery; however, recently, new adjunctive hemostatic agents have been introduced. These include sponge products, non-active oxidized cellulose pads, infrared-sapphire coagulation, and polyvinyl alcohol sponge 1 , 9 . One of the more advanced hemostatic agents is the active fibrin sealant, which has been recently introduced and is commercially available.…”

Section: Introductionmentioning

confidence: 99%

“…One of the more advanced hemostatic agents is the active fibrin sealant, which has been recently introduced and is commercially available. It provides improved hemostasis and wound repair and enables sealing of wounded surfaces and tissues 1 , 10 , 11 , 12 , 13 . Such sealants possess several beneficial properties, namely quick activation, natural clotting process simulation, favorable safety profile, and reabsorbability 3 , 5 , 14 .…”

Section: Introductionmentioning

confidence: 99%

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Safety and efficacy of sFilm-FS, a novel biodegradable fibrin sealant, in Göttingen minipigs

Ramot

Steiner²,

Lavie³

et al. 2021

J Toxicol Pathol

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Bleeding during surgical procedures is a common complication. Therefore, hemostatic agents have been developed to control bleeding, and fibrin sealants have several benefits. sFilm-FS is a novel fibrin sealant that comprises a biodegradable copolymeric film embedded with human fibrinogen and thrombin. Herein, the safety and efficacy of sFilm-FS were compared using a liver and spleen puncture model of Göttingen minipigs with those of the standard hemostatic techniques (control animals) and EVARREST ® , a reference fibrin sealant. Hemostasis and reduced blood loss were more effectively achieved with sFilm-FS than with the standard techniques in the control animals and comparable to those achieved with EVARREST ® . No treatmentrelated adverse effects were observed in any of the groups. Histopathological evaluation indicated that sFilm-FS was slightly and moderately reactive at the liver puncture site and spleen, respectively, compared with the standard techniques in the control animals. These changes are expected degradation reactions of the copolymeric film and are not considered as adverse events. No treatment-related abnormalities were noted in the other evaluated organs. Additionally, no evidence of local or systemic thromboses was noted. These results support the use of sFilm-FS for hemostasis in humans.

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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

Cited by 7 publications

References 25 publications

Characterization of the Components and Functional Properties of a Plasma-Derived Fibrin Sealant

Characterization of the Components and Functional Properties of a Plasma-Derived Fibrin Sealant

Use of hemostatic agents for surgical bleeding in laparoscopic partial nephrectomy: Biomaterials perspective

Safety and efficacy of sFilm-FS, a novel biodegradable fibrin sealant, in Göttingen minipigs

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