MedTrace Logo

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

NCT01500135 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2017-02-08

Study results available
· View outcomes & findings →

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

Interventions

DRUG

TachoSil®

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.

DRUG

Surgicel® Original

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

Sponsors & Collaborators

  • Baxter Healthcare Corporation

    collaborator INDUSTRY

  • Takeda

    lead INDUSTRY

Principal Investigators

  • Medical Director Clinical Science · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2015-06-30
Completion
2015-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01500135 on ClinicalTrials.gov