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.
Brief Title
Comparison of Efficacy and Safety of TachoSil® Versus Surgicel® Original for the Secondary Hemostatic Treatment of Needle Hole Bleeding in Vascular Surgery
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.
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Bleeding
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.
* 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.
Inclusion Criteria
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.
* 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.
Gender
All
Gender Based
false
Keywords
Vascular Surgery
Secondary treatment of needle hole bleeding
Subjects undergoing vascular surgery and who need supportive treatment in order to control bleeding
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT01500135
Org Class
Industry
Org Full Name
Takeda
Org Study Id
TC-2402-039-SP
Overall Status
Completed
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
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
Primary Outcomes
Outcome Description
After application of Investigational Medicinal Product (IMP) light pressure was applied to the IMP with e.g. gauze pads. The first assessment of hemostasis was at minute 3: the pressure was carefully relieved, and the area was observed for visual bleeding at the site of the IMP. If no bleeding was visible, hemostasis was obtained and recorded.
Outcome Measure
Percentage of Participants With Intra-operative Hemostasis at the Evaluation Site Within 3 Minutes After Application of the Randomized Treatment
Outcome Time Frame
Within 3 minutes
Secondary Ids
Secondary Id
U1111-1163-1653
Secondary Outcomes
Outcome Description
After application of Investigational Medicinal Product (IMP) light pressure was applied to the IMP with e.g. gauze pads. If hemostasis was not obtained at minute 3, pressure was immediately reapplied. Hemostasis was re-assessed at minutes 4 and 5.
Outcome Time Frame
Within 5 minutes
Outcome Measure
Percentage of Participants With Intra-operative Hemostasis at the Evaluation Site Within 5 Minutes After Application of the Randomized Treatment
Outcome Description
After application of Investigational Medicinal Product (IMP) light pressure was applied to the IMP with e.g. gauze pads. Hemostasis was assessed at 3, 4, and 5 minutes. If hemostasis was not obtained after 5 minutes a second application of IMP was applied with 3 minutes of light pressure and hemostasis was re-assessed at 8, 9 and 10 minutes.
Outcome Time Frame
Within 10 minutes
Outcome Measure
Time to Intra-operative Hemostasis Within 10 Minutes at the Evaluation Site After Application of the Randomized Treatment
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Stuart Greenstein
Investigator Email
sgreenst@montefiore.org
Investigator Phone
718-920-8269