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
Description
Brief 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.
Detailed 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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