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NCT01192022 · ClinicalTrials.gov registry record · Phase 3
TachoSil® Versus Surgicel® Original for the Secondary Treatment of Local Bleeding in Adult and Pediatric Patients Undergoing Hepatic Resection Surgery
A Phase 3 study of Hemorrhage, sponsored by Takeda.
- Completed
- Registry status
- Phase 3
- Development phase
- 253
- Enrollment target
- 17
- Study locations
NCT01192022: Completed Phase 3 study of Hemorrhage, sponsored by Takeda.
NCT01192022 is a Phase 3 study of Hemorrhage that has completed, run by Takeda. The registered enrollment target is 253 participants, roughly in line with the 254-participant average among 20 other Hemorrhage trials with a reported enrollment target. The trial reports 17 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01192022, a Phase 3 study of Hemorrhage, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 253 participants
- Enrollment target
- 17
- Study locations
Study 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.
Primary Outcome
3 Minutes after the patch was applied to the target bleeding area, the area was observed to see if the bleeding stopped.
Conditions Studied
Interventions
- BIOLOGICAL TachoSil®
- DEVICE Surgicel® Original
Study Locations (17)
Tennessee
- - Memphis
- - Nashville
California
- - Los Angeles
District of Columbia
- - Washington D.C.
Illinois
- - Chicago
Kentucky
- - Louisville
Louisiana
- - New Orleans
Massachusetts
- - Burlington
Missouri
- - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 253 participants |
| Start Date | 2010-08 |
| Est. Completion | 2013-05 |
| Phase | Phase 3 |
What the finished NCT01192022 record still lists
NCT01192022 is an interventional study that assigns participants to a tested intervention. The registered 253 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 254-participant average among 20 other Hemorrhage trials with a reported enrollment target.
The record links to 1 condition, with Hemorrhage appearing as the primary indexed condition, and to 2 interventions - of which TachoSil® is the first listed.
NCT01192022 lists 17 locations in 16 states (Tennessee, California, District of Columbia).
Frequently Asked Questions
What is clinical trial NCT01192022 about?
NCT01192022 is a clinical study titled "TachoSil® Versus Surgicel® Original for the Secondary Treatment of Local Bleeding in Adult and Pediatric Patients Undergoing Hepatic Resection Surgery". 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.
What is the current status of trial NCT01192022?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 253 participants. The study started on 2010-08. Estimated completion is 2013-05.
What conditions does trial NCT01192022 study?
This clinical trial studies the following conditions: Hemorrhage.
What interventions are being tested in trial NCT01192022?
The interventions under investigation include: TachoSil® (BIOLOGICAL), Surgicel® Original (DEVICE).
Who is sponsoring clinical trial NCT01192022?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01192022 being conducted?
This trial has 17 study locations across California, District of Columbia, Illinois, Kentucky, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hemorrhage
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01192022's enrollment target sits among peer trials
253 7th of 20 higher than 14 of 20 other Hemorrhage trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hemorrhage trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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