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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01192022
First received: August 27, 2010
Last updated: June 14, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Hemorrhage
Biological: secondary hemostatic treatment
Device: Surgicel® Original
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Proportion of patients with intraoperative hemostasis at target bleeding site within 3 min of application of randomized treatment [ Time Frame: within 3 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients with intraoperative hemostasis at target bleeding site within 5 min [ Time Frame: within 5 min ] [ Designated as safety issue: No ]
  • Time to intraoperative hemostasis at target bleeding site within 10 min [ Time Frame: within 10 min ] [ Designated as safety issue: No ]

Enrollment: 253
Study Start Date: August 2010
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: TachoSil® Biological: secondary hemostatic treatment
Intraoperative application
Active Comparator: Surgicel® Original Device: Surgicel® Original
Intraoperative application as secondary hemostatic treatment

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01192022

Locations
United States, California
Los Angeles, California, United States
United States, District of Columbia
Washington, District of Columbia, United States
United States, Illinois
Chicago, Illinois, United States
United States, Kentucky
Louisville, Kentucky, United States
United States, Louisiana
New Orleans, Louisiana, United States
United States, Massachusetts
Burlington, Massachusetts, United States
United States, Missouri
St. Louis, Missouri, United States
United States, New Jersey
Newark, New Jersey, United States
United States, New York
New York, New York, United States
United States, North Carolina
Charlotte, North Carolina, United States
United States, Ohio
Cincinnati, Ohio, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, South Carolina
Charleston, South Carolina, United States
United States, Tennessee
Memphis, Tennessee, United States
Nashville, Tennessee, United States
United States, Virginia
Charlottesville, Virginia, United States
United States, Wisconsin
Madison, Wisconsin, United States
Sponsors and Collaborators
Takeda
Investigators
Study Director: Medical Director Takeda
  More Information

No publications provided

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01192022     History of Changes
Other Study ID Numbers: TC-2402-040-SP, U1111-1130-9121
Study First Received: August 27, 2010
Last Updated: June 14, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Takeda:
Liver resection
Liver transplantation
Liver surgery
Secondary hemostasis

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014