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

Authors: Nenezic, D, Ayguasanosa, J, Menyhei, G., Tamas, H, Matyas, L, Muluk, S, Courtney, K, Ibanez, J, Chen, J, and the Investigators of the Fibrin Sealant Grifols in Vascular Surgery Clinical Investigation Study Group.

Publication: Journal of Vascular Surgery; 70,5:1642-1651.

Affiliations: Institute for Cardiovascular Diseases “Dedinje”, Clinic for Vascular Surgery, Belgrade, Serbia; Grifols Bioscience Research Group, Grifols, Barcelona, Spain; Department of Vascular Surgery, Pecs University Clinical Center, Pecs, Hungary; Department of Vascular Surgery, Csolnoky Ferenc County Hospital, Veszprem, Hungary; Department of Vascular and Endovascular Surgery, Borsod Teaching County Hospital Miskolc, Borsod, Hungary; Division of Vascular Surgery, Allegheny General Hospital, Pittsburgh, Pa.

Abstract: OBJECTIVE: New formulations and applications of hemostatic adjuncts such as fibrin sealant (FS) to support local hemostasis and sutures continue to be developed. In a pivotal, confirmatory, controlled, prospective, single-blinded, randomized, multicenter phase III clinical trial, the efficacy and safety of FS Grifols during vascular surgeries were evaluated.