Fibrin Sealant Vascular Surgery Study
Condition: Adjunct to Hemostasis in Vascular Surgery (Synthetic Vascular Grafts)
Intervention: FS VH S/D 500 s-apr, 60-seconds polymerization time; FS VH S/D 500 s-apr, 120-seconds polymerization time; Manual compression with surgical gauze pads
Intervention description: FS VH S/D 500 s-apr (FS) is applied to the study suture line. The actual dose of FS VH S/D 500 s-apr depends on the length of the suture line and the intensity of bleeding and is to be decided by the surgeon, but the maximum dose per suture line shall not exceed 4 mL FS VH S/D 500 s apr. After application of FS VH S/D 500 s-apr to the study suture line is completed, the surgeon will wait for 1 minute to allow polymerization of FS VH S/D 500 s-apr.; Treatment will be identical to the FS VH S/D 500 s-apr Group, 60 seconds polymerization time, except that the surgeons will wait 2 minutes to allow polymerization and will then open the cross clamps.; Treatment of the study suture line with manual compression with surgical gauze pads.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 101.0
Sex: All
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy and safety of Fibrin Sealant, Vapor
      Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D
      500 s-apr) for hemostasis in participants receiving prosthetic expanded
      polytetrafluoroethylene (ePTFE) conduits as compared to a control group treated by manual
      compression with surgical gauze pads.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female of all ages

          -  Subject undergoing peripheral vascular surgery, ie, conduit placement with an ePTFE
             graft such as arterio-arterial bypasses [including: axillo-femoral, ilio-femoral,
             femoro-femoral, ilio-popliteal, femoro-popliteal (including below knee), femoro-tibial
             vessel bypass], or arteriovenous dialysis access shunt in the upper or lower
             extremity.

          -  Signed informed consent

        Intraoperative inclusion criterion:

        - Suture line bleeding eligible for study treatment is present after surgical hemostasis
        (i.e., suturing).

        Suture line bleeding eligible for study treatment is defined as: any suture line bleeding
        that would prevent immediate closure of the wound and require treatment of the bleeding
        first, and on a scale of mild, moderate, and severe, the suture line bleeding is assessed
        as moderate or severe. (Moderate is defined as: either more than 25% of the suture line
        bleeds, or at least 5 suture line bleedings are present, if counting of suture line
        bleedings is possible, or one pulsatile suture line bleeding is present. Severe is defined
        as: either more than 50% of the suture line bleeds, or at least 10 suture line bleedings
        present, if counting of suture line bleedings is possible, or more than one pulsatile
        suture line bleedings are present, or at least one spurting suture line bleeding is
        present.)

        Note: Bleedings that can be treated with additional sutures are not appropriate for the
        study. Such anastomoses should receive additional sutures, be re-categorized, and if they
        still comply with the inclusion criteria, be randomized.

        Exclusion Criteria:

          -  Subjects concurrently participating in another clinical study treatment with another
             investigational drug or device within the last 30 days

          -  Other vascular procedures during the same surgical session (stenting and/or
             endarterectomy of the same artery are allowed)

          -  Arterio-arterial bypasses with more than 2 anastomoses (e.g., aorto-bifemoral,
             axillo-bifemoral etc.)

          -  Pregnant or lactating women

          -  Congenital coagulation disorders

          -  Prior kidney transplantation

          -  Heparin-induced thrombocytopenia

          -  Known prior exposure to aprotinin within the last 12 months

          -  Known hypersensitivity to aprotinin or other components of the product

          -  Known severe congenital or acquired immunodeficiency (e.g., HIV infection or long term
             treatment with immunosuppressive drugs)

          -  Prior radiation therapy to the operating field

          -  Severe local inflammation at the operating field.

        Intraoperative exclusion criterion:

          -  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, (e.g. abandonment of
             ePTFE graft placement).