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A randomized, open label, parallel-group, multi-center trial to compareefficacy and safety of TachoSil® versus Surgicel® Original for the secondaryhemostatic treatment of needle hole bleeding in vascular surgery.

Description

The drug being tested in this study is called TachoSil®. TachoSil® was used to treat people undergoing scheduled subacute vascular surgery. This study looked at how well TachoSil® patches stopped bleeding at the surgical site compared to Surgicel® Original patches. The study enrolled 150 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the two open label treatment groups in a 2:1 ratio: - TachoSil® - Surgicel® Original This multi-center trial was conducted in the United States. The overall time to participate in this study was approximately 6 months. Participants made multiple visits to the clinic, including safety follow-up visits at 1, 3 and 6 months after surgery.

Phase

Phase 3 - a treatment has shown activity against a particular disease, where it is either added to existing treatment or compared to the standard treatment.

Inclusion and Exclusion 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

  • 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.

Sites

Please contact Karen Manrique to learn more about where you can participate in this trial. Please use the contact form on the right side.

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