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

Completed · Phase 3

Conditions studied: Bleeding

In brief

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.

Key facts

Study ID

NCT01500135

Run by

Takeda

People needed

150

Starts

2012-03-01

Expected to finish

2015-12-01

Last updated by the study team

2017-02-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Nycomed Investigational Site — Birmingham, Alabama, United States
• Study site — Birmingham, Alabama, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Long Beach, California, United States
• Nycomed Investigational Site — Los Angeles, California, United States
• Study site — Los Angeles, California, United States
• Study site — Loveland, Colorado, United States
• Study site — Jacksonville, Florida, United States
• Nycomed Investigational Site — Austell, Georgia, United States
• Study site — Austell, Georgia, United States
• Study site — Skokie, Illinois, United States
• Nycomed Investigational Site — Springfield, Illinois, United States
• Study site — Springfield, Illinois, United States
• Nycomed Investigational Site — Lexington, Kentucky, United States
• Study site — Lexington, Kentucky, United States
• Study site — Worcester, Massachusetts, United States
• Study site — Southfield, Michigan, United States
• Study site — St Louis, Missouri, United States
• Study site — Hackensack, New Jersey, United States
• Study site — East Setauket, New York, United States
• Study site — Flushing, New York, United States
• Nycomed Investigational Site — New York, New York, United States
• Study site — New York, New York, United States
• Study site — The Bronx, New York, United States
• Study site — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.