Comparison of Efficacy and Safety of TachoSil® Versus Surgicel® Original for the Secondary Hemostatic Treatment in Vascular Surgery
Status: | Completed |
---|---|
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | March 2012 |
End Date: | December 2015 |
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 one of two trials (the other being a trial in hepatic resection surgery
also comparing TachoSil® and Surgicel® Original) targeted toward providing clinical safety
and efficacy data to support a general hemostasis indication across several surgical
procedures and organ systems in the USA. The patient will come for a screening and baseline
visit, the day of surgery and follow up visits after 1 months, 3 months and 6 months. The
enrollment period is planned for 16 months and 6 months of follow up.
also comparing TachoSil® and Surgicel® Original) targeted toward providing clinical safety
and efficacy data to support a general hemostasis indication across several surgical
procedures and organ systems in the USA. The patient will come for a screening and baseline
visit, the day of surgery and follow up visits after 1 months, 3 months and 6 months. The
enrollment period is planned for 16 months and 6 months of follow up.
Main Inclusion Criteria:
- Planned elective and sub acute 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, femoro-popliteal, femoro-crural
bypass grafting) or a PTFE patch angioplasty of the femoral artery
- The evaluation site for the planned femoral anastomosis must be a de novo site
Intra-operatively (before randomization)
- The subject 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)
Intra-operatively (before randomization)
- Severe bleeding at the anastomosis of the arterial bypass using PTFE graft prosthesis
or the PTFE patch angioplasty
- Disseminated intravascular coagulopathy (DIC)
- Application of topical hemostatic material including fibrin sealant/glue on the
evaluation site
We found this trial at
37
sites
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