Comparison of Efficacy and Safety of TachoSil® Versus Surgicel® Original for the Secondary Hemostatic Treatment of Needle Hole Bleeding in Vascular Surgery
Condition: Bleeding
MeSH terms: Hemorrhage
Intervention: TachoSil®; Surgicel® Original
Intervention description: TachoSil® is a sterile, ready-to-use, absorbable patch for intra-operative topical application. It consists of an equine collagen patch coated with fibrin glue components: human fibrinogen and human thrombin.; Surgicel® Original is an absorbable hemostat (oxidized regenerated cellulose)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Vascular Surgery; Secondary treatment of needle hole bleeding; Subjects undergoing vascular surgery and who need supportive treatment in order to control bleeding

Summary:

      Present trial is the third study that in combination with two completed studies (one being a
      trial in hepatic resection surgery also comparing TachoSil® and Surgicel® Original) targeted
      toward providing clinical safety and efficacy data to support extending the current label of
      TachoSil® to a general hemostasis indication across several surgical procedures and organ
      systems in the USA.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  Planned elective and subacute procedures with a polytetrafluoroethylene (PTFE) graft
             including at least one expected end-to-side anastomosis of a PTFE graft to the femoral
             artery (e.g. femoral-femoral cross-over, aorto-(bi)femoral, axillo-(bi)femoral,
             femoro-popliteal, femoro-crural bypass grafting), a PTFE patch angioplasty of the
             femoral artery, or an end-to-side anastomosis of a PTFE graft to an upper extremity
             artery in connection with arteriovenous bypass grafting for dialysis access.

          -  The evaluation site for the planned femoral anastomosis must be a de novo site.

          -  The participant must be heparinized during surgery.

        Intra-operatively (before randomization)

          -  The participant has a need for secondary hemostatic treatment

          -  Verification of the evaluation site being a de novo site

          -  Verification of the surgical procedure performed as being either an end-to-side or
             PTFE patch angioplasty.

        Main Exclusion Criteria:

          -  Thrombolytic therapy administered within 12 hours before surgery (e.g. the recombinant
             tissue plasminogen activator (rt-PA) Alteplase).

          -  Liver cirrhosis.

        Intra-operatively (before randomization)

          -  Severe bleeding at the anastomosis of the arterial bypass using PTFE graft prosthesis
             or the PTFE patch angioplasty

          -  No bleeding (dry surgical field) at the targeted application area

          -  Disseminated intravascular coagulopathy (DIC)

          -  Application of topical hemostatic material including fibrin sealant/glue on the
             evaluation site.