Status:
COMPLETED
Comparison of Efficacy and Safety of TachoSil® Versus Surgicel® Original for the Secondary Hemostatic Treatment of Needle Hole Bleeding in Vascular Surgery
Lead Sponsor:
Takeda
Collaborating Sponsors:
Baxter Healthcare Corporation
Conditions:
Bleeding
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 providi...
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 blee...
Eligibility Criteria
Inclusion
- Main
- 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
- 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.
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01500135
Start Date
March 1 2012
End Date
December 1 2015
Last Update
February 8 2017
Active Locations (37)
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1
Nycomed Investigational Site
Birmingham, Alabama, United States
2
Birmingham, Alabama, United States
3
Little Rock, Arkansas, United States
4
Long Beach, California, United States