Clinical trial NCT01500135: Comparison of Efficacy and Safety of TachoSil® Versus Surgicel® Original for the Secondary Hemostatic Treatment of Needle Hole Bleeding in Vascular Surgery
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
Overall status: COMPLETED
Phase: PHASE3
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
Lead sponsor: Takeda
Sponsor class: INDUSTRY
Collaborators: name: Baxter Healthcare Corporation
First posted: 2011-12-26
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Percentage of Participants With Intra-operative Hemostasis at the Evaluation Site Within 3 Minutes After Application of the Randomized Treatment
timeFrame: Within 3 minutes
Secondary outcomes:
measure: Percentage of Participants With Intra-operative Hemostasis at the Evaluation Site Within 5 Minutes After Application of the Randomized Treatment
timeFrame: Within 5 minutes
measure: Time to Intra-operative Hemostasis Within 10 Minutes at the Evaluation Site After Application of the Randomized Treatment
timeFrame: Within 10 minutes
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Nycomed Investigational Site
state: Alabama
city: Birmingham
country: United States
state: Alabama
city: Little Rock
country: United States
state: Arkansas
city: Long Beach
country: United States
state: California
city: Los Angeles
country: United States
facility: Nycomed Investigational Site
state: California
city: Los Angeles
country: United States
state: California
city: Loveland
country: United States
state: Colorado
city: Jacksonville
country: United States
state: Florida
city: Austell
country: United States
facility: Nycomed Investigational Site
state: Georgia
city: Austell
country: United States
state: Georgia
city: Skokie
country: United States
state: Illinois
city: Springfield
country: United States
facility: Nycomed Investigational Site
state: Illinois
city: Springfield
country: United States
state: Illinois
city: Lexington
country: United States
facility: Nycomed Investigational Site
state: Kentucky
city: Lexington
country: United States
state: Kentucky
city: Worcester
country: United States
state: Massachusetts
city: Southfield
country: United States
state: Michigan
city: St. Louis
country: United States
state: Missouri
city: Hackensack
country: United States
state: New Jersey
city: Bronx
country: United States
state: New York
city: East Setauket
country: United States
state: New York
city: Flushing
country: United States
state: New York
city: New York
country: United States
facility: Nycomed Investigational Site
state: New York
city: New York
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Winston Salem
country: United States
state: North Carolina
city: Toledo
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Galveston
country: United States
facility: Nycomed Investigational Site
state: Texas
city: Galveston
country: United States
state: Texas
city: Houston
country: United States
facility: Nycomed Investigational Site
state: Texas
city: Houston
country: United States
state: Texas
city: Lubbock
country: United States
state: Texas
city: Bellevue
country: United States
facility: Nycomed Investigational Site
state: Washington
city: Bellevue
country: United States
state: Washington
city: Charleston
country: United States
state: West Virginia
Study officials:
affiliation: Takeda
name: Medical Director Clinical Science
role: STUDY_DIRECTOR
References: