A prospective, single-blind, randomized, phase III study to evaluate the safety and efficacy of Fibrin Sealant Grifols as an adjunct to hemostasis compared with manual compression in vascular surgery

Nenezić, Dragoslav; Ayguasanosa, Jaume; Menyhei, Gábor; Tamás, Holjencsik; Mátyás, Lajos; Muluk, Satish C.; Courtney, Kecia; Ibanez, J Julian; Chen, Junliang; Segura-Vasi, Alvaro M.; Sokurenko, German; Paramesh, Anil; Minkowitz, Harold S.; Sonkin, I.N.; Lal, Brajesh K.; Ihnat, Daniel M.; Brooke, Benjamin S.; Popović, Vladan; Eslami, Mohammad H.; Farber, Alik; Saha, Sibu P.; Greenstein, Stuart; Карпенко, А. А.; Katelnitskiy, Ivan; Tran, Nam; Hoch, John R.; Amin, Ali Hama; White, Paul; Rajani, Ravi R.; Griffin, Joseph; Yurvati, Albert; Matsuura, John H.; Navarro-Puerto, Jordi; Barrera, Gladis; Hames, Carrie; Lloyd, Valerie; Zhang, Yanmei; Lin, Jiang; Li, Henry; Covington, Deborah L.; Henriquez, Waleska; C, Soucheiron; Beck, Susan; Casamiquela, Romà

doi:10.1016/j.jvs.2018.12.051

Cited by 16 publications

(12 citation statements)

References 23 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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“…In this example, we consider a phase III, randomized, prospective, single‐blinded clinical study for evaluating the efficacy and safety of a fibrin sealant (FS) product for supporting local hemostasis and sutures in vascular surgery (Nenezić et al., 2019).…”

Section: Illustrative Examplesmentioning

confidence: 99%

A Bayesian Model with Application for Adaptive Platform Trials Having Temporal Changes

et al. 2022

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Temporal changes exist in clinical trials. Over time, shifts in patients' characteristics, trial conduct, and other features of a clinical trial may occur. In typical randomized clinical trials, temporal effects, that is, the impact of temporal changes on clinical outcomes and study analysis, are largely mitigated by randomization and usually need not be explicitly addressed. However, temporal effects can be a serious obstacle for conducting clinical trials with complex designs, including the adaptive platform trials that are gaining popularity in recent medical product development. In this paper, we introduce a Bayesian robust prior for mitigating temporal effects based on a hidden Markov model, and propose a particle filtering algorithm for computation. We conduct simulation studies to evaluate the performance of the proposed method and provide illustration examples based on trials of Ebola virus disease therapeutics and hemostat in vascular surgery.

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“…Polysaccharide compounds include chitosan, alginates, and chondroitin sulfates [69,70]. A recent phase III clinical trial revealed that a fibrin-based sealant can provide excellent hemostasis, potentially superior to manual compression in patients undergoing open arterial surgery [71]. Interestingly, some of the well-known fibrinbased hemostats which leverage the coagulation cascade as the primary mechanism of action also exhibit a sealant function via covalent interactions with the surrounding tissues [56].…”

Section: Sealant Hemostatsmentioning

confidence: 99%

Operative Hemostasis in Trauma and Acute Care Surgery: The Role of Biosurgical Agents

Dammann¹,

Gifford²,

Kelley³

et al. 2020

Contemporary Applications of Biologic Hemostatic Agents Across Surgical Specialties - Volume 2 [Working Title]

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Trauma and acute care surgery (TACS) constitutes the foundation of emergency surgical services in the United States. Blunt and penetrating traumatic injuries are a leading cause of death worldwide. Non-trauma general surgical emergencies are also a major source of morbidity and mortality. Operative interventions performed within the scope of TACS often revolve around the core principles of contamination control, hemostasis, surgical repair, and subsequent functional restoration. Hemorrhage control is an integral part of emergent operative interventions, and while most instances of surgical bleeding require direct suture ligation or some other form of direct tissue intervention, some circumstances call for the use of adjunctive means of hemostasis. This is especially applicable to situations and settings where direct applications of surgical energy, suture ligation, or direct compression are not possible. Difficult-to-control bleeding can be highly lethal and operative control can be very challenging when confounded by the lethal triad of acidosis, coagulopathy and hypothermia. Topical biosurgical materials (BSM) are of great value in such scenarios, and their use across a variety of settings, from pre-hospital trauma application to emergency general surgery operations, represents an important adjunct to improve patient outcomes. Here we present the different BSMs, discuss their various uses, and provide insight on future applications and developments in this important area.

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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 compared with manual compression in vascular surgery

Cited by 16 publications

References 23 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

A Bayesian Model with Application for Adaptive Platform Trials Having Temporal Changes

Operative Hemostasis in Trauma and Acute Care Surgery: The Role of Biosurgical Agents

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