Comparison of Efficacy and Safety of TachoSil® Versus Surgicel® Original for the Secondary Hemostatic Treatment of Needle Hole Bleeding in Vascular Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Bleeding

Intervention / Treatment
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* Drug: TachoSil®
* Drug: Surgicel® Original


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TachoSil®<br>TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated. | Drug: TachoSil®<br>* TachoSil® is a sterile, ready-to-use, absorbable patch for intra-operative topical application. It consists of an equine collagen patch coated with fibrin glue components: human fibrinogen and human thrombin.<br>|
| Active Comparator: Surgicel® Original<br>Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated. | Drug: Surgicel® Original<br>* Surgicel® Original is an absorbable hemostat (oxidized regenerated cellulose)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Intra-operative Hemostasis at the Evaluation Site Within 3 Minutes After Application of the Randomized Treatment | 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. | Within 3 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Intra-operative Hemostasis at the Evaluation Site Within 5 Minutes After Application of the Randomized Treatment | 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. | Within 5 minutes | 
| Time to Intra-operative Hemostasis Within 10 Minutes at the Evaluation Site After Application of the Randomized Treatment | 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. | Within 10 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vascular Surgery, Secondary treatment of needle hole bleeding, Subjects undergoing vascular surgery and who need supportive treatment in order to control bleeding