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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT01500135

Public ClinicalTrials.gov record NCT01500135. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 18, 2026, 5:37 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01500135
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Takeda
Industry
Enrollment
150 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 2012 (Type not available)
Primary completion
Jun 2015 (Actual)
Completion
Dec 2015 (Actual)
Last update posted
Feb 8, 2017

2012 – 2015

United States locations

U.S. sites
37
U.S. states
19
U.S. cities
28
Facility City State ZIP Site status
Nycomed Investigational Site Birmingham Alabama — —
Not listed Birmingham Alabama — —
Not listed Little Rock Arkansas — —
Not listed Long Beach California — —
Nycomed Investigational Site Los Angeles California — —
Not listed Los Angeles California — —
Not listed Loveland Colorado — —
Not listed Jacksonville Florida — —
Nycomed Investigational Site Austell Georgia — —
Not listed Austell Georgia — —
Not listed Skokie Illinois — —
Nycomed Investigational Site Springfield Illinois — —
Not listed Springfield Illinois — —
Nycomed Investigational Site Lexington Kentucky — —
Not listed Lexington Kentucky — —
Not listed Worcester Massachusetts — —
Not listed Southfield Michigan — —
Not listed St Louis Missouri — —
Not listed Hackensack New Jersey — —
Not listed East Setauket New York — —
Not listed Flushing New York — —
Nycomed Investigational Site New York New York — —
Not listed New York New York — —
Not listed The Bronx New York — —
Not listed Durham North Carolina — —
Not listed Raleigh North Carolina — —
Not listed Winston-Salem North Carolina — —
Not listed Toledo Ohio — —
Not listed Portland Oregon — —
Nycomed Investigational Site Galveston Texas — —
Not listed Galveston Texas — —
Nycomed Investigational Site Houston Texas — —
Not listed Houston Texas — —
Not listed Lubbock Texas — —
Nycomed Investigational Site Bellevue Washington — —
Not listed Bellevue Washington — —
Not listed Charleston West Virginia — —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01500135, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 8, 2017 · Synced Oct 18, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01500135 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →