Keywords: Vascular surgery , hemostasis , fibrin sealant , stop bleeding , bypass graft , hemodialysis access graft , peripheral arterial disease
IRB Number: 00070635
Specialty: Nephrology and Hypertension, Vascular Surgery, Surgery, General
Sub Specialties: Dialysis,
The purpose of this clinical trial is to obtain data to support licensure of a new human plasma-derived
FS (FS Grifols), manufactured by Instituto Grifols, S.A., Barcelona, Spain, by demonstrating that FS
Grifols is both safe and effective in achieving hemostasis during parenchymous tissue open surgeries.
Safety objectives include clinical safety, viral safety and immunogenicity.
The efficacy objective is to evaluate the hemostatic efficacy of FS Grifols in parenchymous tissue