Phase 3
N=150
Comparison of Efficacy and Safety of TachoSil® Versus Surgicel® Original for the Secondary Hemostatic Treatment of Needle Hole Bleeding in Vascular Surgery
Bleeding
Bottom Line
View on ClinicalTrials.gov: NCT01500135 ↗Enrolled (actual)
150
Serious AEs
45.6%
Results posted
Feb 2017
Primary outcome: Primary: Percentage of Participants With Intra-operative Hemostasis at the Evaluation Site Within 3 Minutes After Application of the Randomized Treatment — 26.0; 18.0 percentage of participants — p=0.276
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- TachoSil® (Drug); Surgicel® Original (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Intra-operative Hemostasis at the Evaluation Site Within 3 Minutes After Application of the Randomized Treatment |
26.0; 18.0 | 0.276 |
| SECONDARY Percentage of Participants With Intra-operative Hemostasis at the Evaluation Site Within 5 Minutes After Application of the Randomized Treatment |
39.0; 42.0 | 0.684 |
| SECONDARY Time to Intra-operative Hemostasis Within 10 Minutes at the Evaluation Site After Application of the Randomized Treatment |
8.0; 8.0 | 0.684 |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01500135). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.