At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 253 enrolled
Drug / intervention
TachoSil® +1 morebiological
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.
A Randomized, Open Label, Parallel-group, Multi-center Trial to Compare the Efficacy and Safety of TachoSil® Versus Surgicel® Original for the Secondary Treatment of Local Bleeding in Adult and Pediatric Patients Undergoing Hepatic Resection Surgery
In Brief
A Phase 3 clinical trial evaluating TachoSil® and Surgicel® Original for Hemorrhage. Completed, enrolled 253 participants across 17 sites.
Detailed Summary
The efficacy and safety of TachoSil® as secondary hemostatic treatment in hepatic resection surgery will be compared to the standard USA licensed hemostatic agent, Surgicel® Original. Hemostatic efficacy will be evaluated intraoperatively after application of randomized treatment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemorrhage
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartAug 2010
First PostedAug 2010
Primary CompletionMay 2013
TodayJul 2026
First PostedAug 31, 2010
Enrollment StartAug 1, 2010
Primary CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 15.8 years ago
Interventions
TachoSil®biological
Intraoperative application as secondary hemostatic treatment
Surgicel® Originaldevice
Intraoperative application as secondary hemostatic treatment