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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)

Primary Purpose

Bleeding

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
TachoSil®
Surgicel® Original
Sponsored by
Takeda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bleeding focused on measuring Vascular Surgery, Secondary treatment of needle hole bleeding, Subjects undergoing vascular surgery and who need supportive treatment in order to control bleeding

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nycomed Investigational Site
  • Nycomed Investigational Site
  • Nycomed Investigational Site
  • Nycomed Investigational Site
  • Nycomed Investigational Site
  • Nycomed Investigational Site
  • Nycomed Investigational Site
  • Nycomed Investigational Site
  • Nycomed Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TachoSil®

Surgicel® Original

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
December 21, 2011
Last Updated
December 15, 2016
Sponsor
Takeda
Collaborators
Baxter Healthcare Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01500135
Brief Title
Comparison of Efficacy and Safety of TachoSil® Versus Surgicel® Original for the Secondary Hemostatic Treatment of Needle Hole Bleeding in Vascular Surgery
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda
Collaborators
Baxter Healthcare Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bleeding
Keywords
Vascular Surgery, Secondary treatment of needle hole bleeding, Subjects undergoing vascular surgery and who need supportive treatment in order to control bleeding

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TachoSil®
Arm Type
Experimental
Arm Description
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.
Arm Title
Surgicel® Original
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
TachoSil®
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Surgicel® Original
Intervention Description
Surgicel® Original is an absorbable hemostat (oxidized regenerated cellulose)
Primary Outcome Measure Information:
Title
Percentage of Participants With Intra-operative Hemostasis at the Evaluation Site Within 3 Minutes After Application of the Randomized Treatment
Description
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.
Time Frame
Within 3 minutes
Secondary Outcome Measure Information:
Title
Percentage of Participants With Intra-operative Hemostasis at the Evaluation Site Within 5 Minutes After Application of the Randomized Treatment
Description
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 Frame
Within 5 minutes
Title
Time to Intra-operative Hemostasis Within 10 Minutes at the Evaluation Site After Application of the Randomized Treatment
Description
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.
Time Frame
Within 10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director Clinical Science
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Nycomed Investigational Site
City
Birmingham
State/Province
Alabama
Country
United States
City
Birmingham
State/Province
Alabama
Country
United States
City
Little Rock
State/Province
Arkansas
Country
United States
City
Long Beach
State/Province
California
Country
United States
Facility Name
Nycomed Investigational Site
City
Los Angeles
State/Province
California
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
Loveland
State/Province
Colorado
Country
United States
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Nycomed Investigational Site
City
Austell
State/Province
Georgia
Country
United States
City
Austell
State/Province
Georgia
Country
United States
City
Skokie
State/Province
Illinois
Country
United States
Facility Name
Nycomed Investigational Site
City
Springfield
State/Province
Illinois
Country
United States
City
Springfield
State/Province
Illinois
Country
United States
Facility Name
Nycomed Investigational Site
City
Lexington
State/Province
Kentucky
Country
United States
City
Lexington
State/Province
Kentucky
Country
United States
City
Worcester
State/Province
Massachusetts
Country
United States
City
Southfield
State/Province
Michigan
Country
United States
City
St. Louis
State/Province
Missouri
Country
United States
City
Hackensack
State/Province
New Jersey
Country
United States
City
Bronx
State/Province
New York
Country
United States
City
East Setauket
State/Province
New York
Country
United States
City
Flushing
State/Province
New York
Country
United States
Facility Name
Nycomed Investigational Site
City
New York
State/Province
New York
Country
United States
City
New York
State/Province
New York
Country
United States
City
Durham
State/Province
North Carolina
Country
United States
City
Raleigh
State/Province
North Carolina
Country
United States
City
Winston Salem
State/Province
North Carolina
Country
United States
City
Toledo
State/Province
Ohio
Country
United States
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Nycomed Investigational Site
City
Galveston
State/Province
Texas
Country
United States
City
Galveston
State/Province
Texas
Country
United States
Facility Name
Nycomed Investigational Site
City
Houston
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
Lubbock
State/Province
Texas
Country
United States
Facility Name
Nycomed Investigational Site
City
Bellevue
State/Province
Washington
Country
United States
City
Bellevue
State/Province
Washington
Country
United States
City
Charleston
State/Province
West Virginia
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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