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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Takeda
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01500135
First received: December 21, 2011
Last updated: October 30, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Bleeding
Drug: TachoSil®
Drug: Surgicel® Original
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Intra-operative hemostasis at the evaluation site within 3 minutes after application of the randomized treatment [ Time Frame: At minute 3 ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Intra-operative hemostasis at the evaluation site within 5 minutes after application of the randomized treatment [ Time Frame: At minute 4 and 5 ] [ Designated as safety issue: No ]

    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.


  • Time to intra-operative hemostasis at the evaluation site within 10 minutes after application of the randomized treatment [ Time Frame: At minute 8, 9 and 10 ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 150
Study Start Date: March 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TachoSil® 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.
Active Comparator: Surgicel® Original Drug: Surgicel® Original
Surgicel® Original is an absorbable hemostat (oxidized regenerated cellulose)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01500135

Contacts
Contact: Takeda Study Registration Call Center +1-800-778-2860 ext 0 medicalinformation@tpna.com

  Show 37 Study Locations
Sponsors and Collaborators
Takeda
Baxter Healthcare Corporation
  More Information

No publications provided

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01500135     History of Changes
Other Study ID Numbers: TC-2402-039-SP, U1111-1163-1653
Study First Received: December 21, 2011
Last Updated: October 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Takeda:
Vascular Surgery
Secondary treatment of needle hole bleeding
Subjects undergoing vascular surgery and who need supportive treatment in order to control bleeding

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
Hemostatics
Coagulants
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014