Comparison of Efficacy and Safety of TachoSil® Versus Surgicel® Original for the Secondary Hemostatic Treatment of Needle Hole Bleeding in Vascular Surgery

A Randomized, Open Label, Parallel-group, Multi-center Trial to Compare Efficacy and Safety of TachoSil® Versus Surgicel® Original for the Secondary Hemostatic Treatment of Needle Hole Bleeding in Vascular Surgery

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.

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.

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.