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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 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.

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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.

Conditions Studied

Hemorrhage

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

FieldValue
Enrollment Target 253 participants
Start Date 2010-08
Est. Completion 2013-05
Phase Phase 3

Sponsor

Takeda

408 total trials

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What the Registry Record Tells You About NCT01192022

The ClinicalTrials.gov registry entry for NCT01192022 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 253 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 254-participant average among 20 other Hemorrhage trials with a reported enrollment target. The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.

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 reports 17 study locations spanning 16 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.