A Prospective, Randomized, Multicenter Clinical Trial on the Safety and Efficacy of a Ready-to-Use Fibrin Sealant as an Adjunct to Hemostasis during Vascular Surgery

Abstract

FS Grifols was efficacious and safe as an adjunct to anastomotic hemostasis in patients undergoing arterial surgery using prosthetic material with mild to moderate bleeding.

Recent Advances in Hemostasis at the Nanoscale

“…The final stage of the physiological coagulation cascade results in the production of thrombin, which converts fibrinogen to fibrin and eventually forms a semi‐rigid fibrin clot that blocks the bleeding port. Chetter et al found that fibrin Grifols has better hemostatic effect than manual pressurization and is safe and effective for patients with mild to moderate bleeding …”

A Prospective, Randomized, Phase III Study to Evaluate the Efficacy and Safety of Fibrin Sealant Grifols as an Adjunct to Hemostasis as Compared to Cellulose Sheets in Hepatic Surgery Resections

“…FS Grifols is a product composed of frozen solutions of highly purified human fibrinogen (80 mg/mL) and human thrombin (500 IU/mL) with calcium chloride (5.9 mg/mL) supplied as a ready-to-use kit, in pre-loaded glass syringes assembled on a syringe holder. 13 For the specific use on the surface of hepatic resections, FS Grifols was delivered using spray applicator tips [Gas Assisted Applicator Kit, 5 cm 3 . Micromedics, Inc. Eagan, MN, USA].…”

“…The primary efficacy endpoint of the study was the proportion of patients in both treatment groups who achieved hemostasis at the TBS by 4 min (T 4 ) following the T Start without occurrence of re-bleeding until the completion of the surgical closure. The 4-min time point was chosen based on efficacy results observed in previous studies with other FS products and previous data, 8,[13][14][15][16][17][18][19][20][21][22] as well as on the US FDA feedback provided to the sponsor in discussing the protocol design and its adequacy for the aim of supporting a marketing application in the claimed indication. Hemostasis was defined as a cessation of bleeding at the TBS.…”

“…[8][9][10] Fibrin sealant patches have demonstrated superior efficacy to argon beam coagulator treatment 11 or to Surgicel® for achieving hemostasis in patients undergoing hepatic resection. 12 Fibrin Sealant Grifols (FS Grifols; Instituto Grifols S.A., Barcelona, Spain) is composed of highly purified human fibrinogen and human thrombin and supplied as a ready-to-use kit that can be applied directly on vascular injuries 13 or conveniently sprayed on open raw surfaces. The present study has evaluated the effectiveness and safety of FS Grifols applied as a spray in comparison with standard Surgicel® sheets in the control of bleeding following open hepatic resections.…”

Analysis of structure and properties of antibacterial vascular patch used in abdominal aorta aneurysm surgeries

“…The biocompatibility of polytetrafluoroethylene and Dacron has been proved in many in vivo and clinical tests. [12][13][14][15][16][17] Apart from biologically stable materials (practically non-degraded in an organism), biodegradable materials are increasingly being used. The best known are: polylactic acid and its copolymers, poly-ε-caprolactone, poly(glycolic acid), alginates, or chitin derivatives.…”