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

Bleeding Clinical Trial

— VASUS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01500135
• Other study ID #: TC-2402-039-SP
• Secondary ID: U1111-1163-1653
• Status: Completed
• Phase: Phase 3
• First received: December 21, 2011
• Last updated: August 19, 2016
• Start date: March 2012
• Est. completion date: December 2015

Study information

• Verified date: August 2016
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bleeding
• Hemorrhage

Intervention

Drug:
• TachoSil®
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.
• Surgicel® Original
Surgicel® Original is an absorbable hemostat (oxidized regenerated cellulose)

Locations

Country	Name	City	State
United States	Nycomed Investigational Site	Austell	Georgia
United States	Nycomed Investigational Site	Bellevue	Washington
United States	Nycomed Investigational Site	Birmingham	Alabama
United States	Nycomed Investigational Site	Galveston	Texas
United States	Nycomed Investigational Site	Houston	Texas
United States	Nycomed Investigational Site	Lexington	Kentucky
United States	Nycomed Investigational Site	Los Angeles	California
United States	Nycomed Investigational Site	New York	New York
United States	Nycomed Investigational Site	Springfield	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Takeda	Baxter Healthcare Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 is applied to the IMP with e.g. gauze pads.; The first assessment of hemostasis is at minute 3: the pressure is carefully relieved, and it is observed if there is visual bleeding at the site of IMP. If no bleeding is visible, hemostasis is obtained and recorded.	At minute 3	No
Secondary	Intra-operative hemostasis at the evaluation site within 5 minutes after application of the randomized treatment	The assessment is performed similarly as for the primary endpoint.; If hemostasis is not obtained at minute 3, pressure is immediately reapplied. Hemostasis is re-assessed at minute 4 and 5.	At minute 4 and 5	No
Secondary	Time to intra-operative hemostasis at the evaluation site within 10 minutes after application of the randomized treatment	The assessment is performed similarly as for the primary endpoint.; If hemostasis is not obtained after 5 minutes a second application of IMP is applied with 3 minutes of light pressure and hemostasis is re-assessed at 8, 9 and 10 minutes after the first application.	At minute 8, 9 and 10	No