FS VH S/D 500 S-apr in Vascular Surgery
Condition: Hemostasis in Participants Receiving Peripheral Vascular Expanded Polytetrafluoroethylene (ePTFE) Graft Prostheses
Intervention: Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr); Surgical gauze pads
Intervention description: The actual dose of FS VH S/D 500 s-apr will depend on the length of the suture line and the intensity of bleeding (but shall not exceed 4 mL FS VH S/D 500 s-apr).; Manual compression with surgical gauze pads
Intervention MeSH terms: Thrombin; Fibrin Tissue Adhesive; Aprotinin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 176.0
Sex: All
Healthy volunteers: No
Keywords: Vascular Surgery; Arterio-arterial bypasses; Arterio-venous (AV) shunts

Summary:

      The purpose of this study was to compare safety and efficacy of FS VH S/D 500 s-apr (FS)
      versus manual compression in prosthetic expanded polytetrafluoroethylene (ePTFE) graft
      placement.
    

Eligibility criteria:

        Inclusion Criteria:

        Preoperative inclusion criteria:

          -  Subjects undergoing vascular surgery (ie, conduit placement with an ePTFE graft),
             including arterio-arterial bypasses, including:

               -  axillo-femoral

               -  axillo-bifemoral

               -  aorto-bifemoral

               -  ilio-femoral

               -  femoro-femoral

               -  ilio-popliteal

               -  femoro-popliteal (including below knee)

               -  femoro-tibial vessel bypass

               -  arterio-venous shunting for dialysis access in the upper or lower extremity

          -  Signed informed consent

          -  Subject is of childbearing potential, presents with a negative serum or urine
             pregnancy test, and agrees to employ adequate birth control measures for the duration
             of the study.

          -  Subject is willing and able to comply with the requirements of the protocol.

        Intraoperative inclusion criterion:

          -  Suture line bleeding eligible for study treatment is present after surgical hemostasis
             (ie, suturing). (A definition of eligible suture line bleeding is provided in the
             study protocol.)

        Exclusion Criteria:

        Preoperative exclusion criteria:

          -  Other vascular procedures during the same surgical session (stenting and/or
             endarterectomy of the same artery are allowed)

          -  Congenital coagulation disorders

          -  Prior kidney transplantation

          -  Heparin-induced thrombocytopenia

          -  Known hypersensitivity to heparin

          -  Known hypersensitivity to aprotinin or other components of the product

          -  Known severe congenital or acquired immunodeficiency (eg, HIV infection or long-term
             treatment with immunosuppressive drugs (eg, organ transplantation patients)

          -  Prior radiation therapy to the operating field

          -  Severe local inflammation at the operating field

          -  Subject is pregnant or lactating at the time of enrollment

          -  Subject has participated in another clinical study involving an investigational
             product (IP) or investigational device within 30 days prior to enrollment or is
             scheduled to participate in another clinical study involving an IP or investigational
             device during the course of this study

          -  Subject has previously participated in this study (Protocol No.: 550801), ie, each
             subject can only be enrolled once.

        Intraoperative Exclusion Criteria:

          -  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, (eg, abandonment of
             ePTFE graft placement)