TachoSil® Versus Surgicel® Original for the Secondary Treatment of Local Bleeding in Adult and Pediatric Patients Undergoing Hepatic Resection Surgery

October 22, 2015 updated by: Takeda

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

253

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States
    • District of Columbia
      • Washington, District of Columbia, United States
    • Illinois
      • Chicago, Illinois, United States
    • Kentucky
      • Louisville, Kentucky, United States
    • Louisiana
      • New Orleans, Louisiana, United States
    • Massachusetts
      • Burlington, Massachusetts, United States
    • Missouri
      • St. Louis, Missouri, United States
    • New Jersey
      • Newark, New Jersey, United States
    • New York
      • New York, New York, United States
    • North Carolina
      • Charlotte, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
    • South Carolina
      • Charleston, South Carolina, United States
    • Tennessee
      • Memphis, Tennessee, United States
      • Nashville, Tennessee, United States
    • Virginia
      • Charlottesville, Virginia, United States
    • Wisconsin
      • Madison, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Resection of at least the equivalent tissue volume of 1 anatomical segment of the liver
  • Minor to moderate (oozing/diffuse) bleeding from the resection area persisting after conventional resection procedure and primary control of arterial pulsating bleeding or major venous hemorrhage by sutures, ligations, clips, vascular stapler, point electrocautery or focal radiofrequency ablation
  • Need for additional supportive hemostatic treatment
  • Expected ability to lightly press the trial treatment to the liver resection wound for 3 minutes

Exclusion Criteria:

  • Indication for emergency surgery
  • Known coagulopathy (as judged relevant by the investigator)
  • Known or suspected hypersensitivity to any ingredient of the investigational medicinal products (e.g. human fibrinogen, human thrombin and/or collagen of any origin)
  • Patient unwilling to receive blood products
  • Known current alcohol or drug abuse
  • Pregnancy, breastfeeding, no use of acceptable contraceptive method in females of childbearing potential
  • Dry surgical field of the targeted application area
  • Occurrence of any serious surgical complication
  • Disseminated intravascular coagulopathy (DIC), i.e. microvascular bleeding
  • Application of topical hemostatic material on the liver resection wound
  • Radiofrequency precoagulation of the liver resection wound except focal radiofrequency ablation of vessels as primary hemostatic treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: TachoSil®
TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
Biological: TachoSil®
Intraoperative application as secondary hemostatic treatment
ACTIVE_COMPARATOR: Surgicel® Original
Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
Device: Surgicel® Original
Intraoperative application as secondary hemostatic treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Intraoperative Hemostasis at Target Bleeding Site Within 3 Minutes
Time Frame: within 3 minutes
3 Minutes after the patch was applied to the target bleeding area, the area was observed to see if the bleeding stopped.
within 3 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Intraoperative Hemostasis at Target Bleeding Site Within 5 Minutes
Time Frame: within 5 minutes
3, 4 and 5 minutes after the patch was applied to the target bleeding area, the area was observed to see if the bleeding stopped.
within 5 minutes
Time to Intraoperative Hemostasis at Target Bleeding Site
Time Frame: 10 minutes
The target bleeding area was observed at 3, 4, 5, 8, 9, and 10 minutes after the patch was applied to see if the bleeding stopped, and time in minutes until bleeding stopped was recorded.
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Takeda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (ACTUAL)

May 1, 2013

Study Completion (ACTUAL)

May 1, 2013

Study Registration Dates

First Submitted

August 27, 2010

First Submitted That Met QC Criteria

August 30, 2010

First Posted (ESTIMATE)

August 31, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

November 25, 2015

Last Update Submitted That Met QC Criteria

October 22, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TC-2402-040-SP
  • U1111-1130-9121 (REGISTRY: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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