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

NCT01500135 | Completed Phase 3 Results DMC

• 2 other identifiers: TC-2402-039-SPU1111-1163-1653
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 37

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.

Conditions

Bleeding

Keywords

Vascular Surgery; Secondary treatment of needle hole bleeding; Subjects undergoing vascular surgery and who need supportive treatment in order to control bleeding

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Percentage of Participants With Intra-operative Hemostasis at the Evaluation Site Within 5 Minutes After Application of the Randomized Treatment

  Within 5 minutes

• Time to Intra-operative Hemostasis Within 10 Minutes at the Evaluation Site After Application of the Randomized Treatment

  Within 10 minutes

Study Arms (2)

TachoSil®

EXPERIMENTAL

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®

Surgicel® Original

ACTIVE COMPARATOR

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

Interventions

TachoSil® DRUG

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.

TachoSil®

Surgicel® Original DRUG

Surgicel® Original is an absorbable hemostat (oxidized regenerated cellulose)

Surgicel® Original

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Takeda: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (37)

Nycomed Investigational Site

Birmingham, Alabama, United States

Location

Unknown Facility

Birmingham, Alabama, United States

Location

Unknown Facility

Little Rock, Arkansas, United States

Location

Unknown Facility

Long Beach, California, United States

Location

Nycomed Investigational Site

Los Angeles, California, United States

Location

Unknown Facility

Los Angeles, California, United States

Location

Unknown Facility

Loveland, Colorado, United States

Location

Unknown Facility

Jacksonville, Florida, United States

Location

Nycomed Investigational Site

Austell, Georgia, United States

Location

Unknown Facility

Austell, Georgia, United States

Location

Unknown Facility

Skokie, Illinois, United States

Location

Nycomed Investigational Site

Springfield, Illinois, United States

Location

Unknown Facility

Springfield, Illinois, United States

Location

Nycomed Investigational Site

Lexington, Kentucky, United States

Location

Unknown Facility

Lexington, Kentucky, United States

Location

Unknown Facility

Worcester, Massachusetts, United States

Location

Unknown Facility

Southfield, Michigan, United States

Location

Unknown Facility

St Louis, Missouri, United States

Location

Unknown Facility

Hackensack, New Jersey, United States

Location

Unknown Facility

East Setauket, New York, United States

Location

Unknown Facility

Flushing, New York, United States

Location

Nycomed Investigational Site

New York, New York, United States

Location

Unknown Facility

New York, New York, United States

Location

Unknown Facility

The Bronx, New York, United States

Location

Unknown Facility

Durham, North Carolina, United States

Location

Unknown Facility

Raleigh, North Carolina, United States

Location

Unknown Facility

Winston-Salem, North Carolina, United States

Location

Unknown Facility

Toledo, Ohio, United States

Location

Unknown Facility

Portland, Oregon, United States

Location

Nycomed Investigational Site

Galveston, Texas, United States

Location

Unknown Facility

Galveston, Texas, United States

Location

Nycomed Investigational Site

Houston, Texas, United States

Location

Unknown Facility

Houston, Texas, United States

Location

Unknown Facility

Lubbock, Texas, United States

Location

Nycomed Investigational Site

Bellevue, Washington, United States

Location

Unknown Facility

Bellevue, Washington, United States

Location

Unknown Facility

Charleston, West Virginia, United States

Location

MeSH Terms

Conditions

Hemorrhage

Interventions

TachoSil

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Director Clinical Science

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2011
• First Posted: December 26, 2011
• Study Start: March 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 8, 2017
• Results First Posted: February 8, 2017

Record last verified: 2016-12

Locations

US (37)