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

This study has been completed.
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01500135
First received: December 21, 2011
Last updated: December 15, 2016
Last verified: December 2016
  Purpose
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.

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

Study Type: Interventional
Study Design: Allocation: Randomized
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:
  • Percentage of Participants With Intra-operative Hemostasis at the Evaluation Site Within 3 Minutes After Application of the Randomized Treatment [ Time Frame: Within 3 minutes ]
    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.


Secondary Outcome Measures:
  • Percentage of Participants With Intra-operative Hemostasis at the Evaluation Site Within 5 Minutes After Application of the Randomized Treatment [ Time Frame: Within 5 minutes ]
    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.

  • Time to Intra-operative Hemostasis Within 10 Minutes at the Evaluation Site After Application of the Randomized Treatment [ Time Frame: Within 10 minutes ]
    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.


Enrollment: 150
Study Start Date: March 2012
Study Completion Date: December 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TachoSil®
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®
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
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
Surgicel® Original is an absorbable hemostat (oxidized regenerated cellulose)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  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

  Show 37 Study Locations
Sponsors and Collaborators
Takeda
Baxter Healthcare Corporation
Investigators
Study Director: Medical Director Clinical Science Takeda
  More Information

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01500135     History of Changes
Other Study ID Numbers: TC-2402-039-SP
U1111-1163-1653 ( Registry Identifier: WHO )
Study First Received: December 21, 2011
Results First Received: December 15, 2016
Last Updated: December 15, 2016

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

ClinicalTrials.gov processed this record on April 21, 2017