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

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda
• Collaborator: Baxter Healthcare Corporation
• Treatments: Hemostatics

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.