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

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ClinicalTrials.gov Identifier: NCT01192022
Recruitment Status : Completed
First Posted : August 31, 2010
Results First Posted : November 25, 2015
Last Update Posted : November 25, 2015
Sponsor:
Information provided by (Responsible Party):
Takeda

Brief 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.

Condition or disease Intervention/treatment Phase
Hemorrhage Biological: TachoSil® Device: Surgicel® Original Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 253 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : August 2010
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
Drug Information available for: TachoSil
U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01192022     History of Changes
Other Study ID Numbers: TC-2402-040-SP
U1111-1130-9121 ( Registry Identifier: WHO )
First Posted: August 31, 2010    Key Record Dates
Results First Posted: November 25, 2015
Last Update Posted: November 25, 2015
Last Verified: October 2015

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

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes