Safety and Efficacy Study of Fibrin Sealant Grifols as an Adjunct to Hemostasis During Peripheral Vascular Surgery

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 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. This study has a Preliminary Part (I) in which all subjects are treated with Fibrin Sealant Grifols and a Primary Part (II) in which subjects are randomized in a 2:1 ratio to either Fibrin Sealant Grifols or manual compression.

Inclusion Criteria:

• Hemoglobin (Hgb) ≥ 8.0 g/dL at Baseline (within 24 hours prior to surgical procedure).
• Require elective (non-emergency), primary, open (non-laparoscopic; non-endovascular) peripheral vascular surgery.
• Require one of the following peripheral vascular procedures involving proximal end-to-side arterial anastomosis utilizing coated or uncoated Polytetrafluoroethylene grafts: a) Femoral-femoral bypass grafting, b) Femoral-popliteal bypass grafting, c) Femoral-distal bypass grafting, d) Ilio-iliac bypass grafting, e) Ilio-femoral bypass grafting, f) Ilio-popliteal bypass grafting, g) Aorto-iliac bypass grafting, h) Aorto-femoral bypass grafting, i)Axillo-femoral bypass grafting, and j) Upper extremity vascular access for hemodialysis.
• A target bleeding site can be identified.
• Target bleeding site has moderate arterial bleeding.

Exclusion Criteria:

• Undergoing a re-operative procedure.
• Undergoing other vascular procedures during the same surgical session (stenting and/or endarterectomy of the same artery are allowed).
• Have an infection in the anatomic surgical area.
• Have a history of severe (e.g. anaphylactic) reactions to blood or to any blood-derived product.
• Have previous known sensitivity to any Fibrin Sealant Grifols, heparin, or protamine component.
• Females who are pregnant or nursing a child at Baseline (within 24 hours prior to surgical procedure).
• Have undergone a therapeutic surgical procedure within 30 days from the screening visit.
• Target bleeding site cannot be identified.
• Target bleeding site has mild or severe arterial bleeding.
• Occurrence of major intraoperative complications that require resuscitation or deviation from the planned surgical procedure.
• Intraoperative change in planned surgical procedure, which results in subject no longer meeting preoperative inclusion and/or exclusion criteria.