Peripheral Vascular Surgical Bleeding Clinical Trial
Official title:
A Prospective, Single-blind, Randomized, Phase III Study to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) as an Adjunct to Hemostasis During Peripheral Vascular Surgery
The purpose of this study is to demonstrate that the application of Fibrin Sealant (FS) Grifols provides a measurable benefit when compared to hemostasis achieved through conventional surgical technique (suture) and by standard hemostatic action, such as mechanical pressure through manual compression (MC). This study has a Preliminary Part (I) in which all subjects are treated with FS Grifols and a Primary Part (II) in which subjects will be randomized in a 2:1 ratio to either FS Grifols or MC.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment