CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 150 enrolled
Drug / intervention
TachoSil® +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01500135
NCT01500135Phase 3Completed
CompareCT.gov

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

Takeda·interventional·Posted Dec 26, 2011·Updated Feb 8, 2017

In Brief

A Phase 3 clinical trial evaluating TachoSil® and Surgicel® Original for Bleeding. Completed, enrolled 150 participants across 37 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBleeding
CountriesUnited States
CollaboratorsBaxter Healthcare Corporation

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 26, 2011
Enrollment StartMar 1, 2012
Primary CompletionJun 1, 2015
Study CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 14.5 years ago

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.

Surgicel® Originaldrug

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