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

Launched by TAKEDA · Dec 23, 2011

Keywords

ClinConnect Summary

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 mont...

Gender

ALL

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.