NCT01192022

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
253

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Aug 2010

Typical duration for phase_3

Geographic Reach
1 country

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

August 27, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 31, 2010

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

November 25, 2015

Completed
Last Updated

November 25, 2015

Status Verified

October 1, 2015

Enrollment Period

2.8 years

First QC Date

August 27, 2010

Results QC Date

August 13, 2015

Last Update Submit

October 22, 2015

Conditions

Hemorrhage

Keywords

Liver resectionLiver transplantationLiver surgerySecondary hemostasis

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Intraoperative Hemostasis at Target Bleeding Site 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 Outcomes (2)

  • Percentage of Participants With Intraoperative Hemostasis at Target Bleeding Site Within 5 Minutes

    within 5 minutes

  • Time to Intraoperative Hemostasis at Target Bleeding Site

    10 minutes

Study Arms (2)

TachoSil®

ACTIVE COMPARATOR

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®

Surgicel® Original

ACTIVE COMPARATOR

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

Interventions

TachoSil®BIOLOGICAL

Intraoperative application as secondary hemostatic treatment

TachoSil®
Surgicel® OriginalDEVICE

Intraoperative application as secondary hemostatic treatment

Surgicel® Original

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Unknown Facility

Los Angeles, California, United States

Location

Unknown Facility

Washington D.C., District of Columbia, United States

Location

Unknown Facility

Chicago, Illinois, United States

Location

Unknown Facility

Louisville, Kentucky, United States

Location

Unknown Facility

New Orleans, Louisiana, United States

Location

Unknown Facility

Burlington, Massachusetts, United States

Location

Unknown Facility

St Louis, Missouri, United States

Location

Unknown Facility

Newark, New Jersey, United States

Location

Unknown Facility

New York, New York, United States

Location

Unknown Facility

Charlotte, North Carolina, United States

Location

Unknown Facility

Cincinnati, Ohio, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, United States

Location

Unknown Facility

Charleston, South Carolina, United States

Location

Unknown Facility

Memphis, Tennessee, United States

Location

Unknown Facility

Nashville, Tennessee, United States

Location

Unknown Facility

Charlottesville, Virginia, United States

Location

Unknown Facility

Madison, Wisconsin, United States

Location

Related Publications (1)

  • Genyk Y, Kato T, Pomposelli JJ, Wright JK Jr, Sher LS, Tetens V, Chapman WC. Fibrin Sealant Patch (TachoSil) vs Oxidized Regenerated Cellulose Patch (Surgicel Original) for the Secondary Treatment of Local Bleeding in Patients Undergoing Hepatic Resection: A Randomized Controlled Trial. J Am Coll Surg. 2016 Mar;222(3):261-8. doi: 10.1016/j.jamcollsurg.2015.12.007. Epub 2015 Dec 18.

    PMID: 26776356DERIVED

MeSH Terms

Conditions

Hemorrhage

Interventions

TachoSil

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Medical Director, Clinical Science
Organization
Takeda
clinicaltrialregistry@tpna.com
800-778-2860

Study Officials

  • Medical Director

    Takeda

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2010

First Posted

August 31, 2010

Study Start

August 1, 2010

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

November 25, 2015

Results First Posted

November 25, 2015

Record last verified: 2015-10

Locations

US(17)