Safety and Efficacy Study of Fibrin Sealant Grifols as an Adjunct to Hemostasis During Peripheral Vascular Surgery
Condition: Vascular Surgical Bleeding
Intervention: Fibrin Sealant Grifols; Manual Compression
Intervention description: Combination of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total).; Direct manual compression of target bleeding site with gauze/laparotomy pads.
Intervention MeSH terms: Fibrin Tissue Adhesive
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Enrollment: 225.0
Sex: All
Healthy volunteers: No
Keywords: Vascular Surgery; Fibrin Sealant; Polytetrafluoroethylene (PTFE) grafts

Summary:

      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.
    

Eligibility criteria:

        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.