Back to resultsTachoSil® Versus Surgicel® Original for the Secondary Treatment of Local Bleeding in Adult and Pediatric Patients Undergoing Hepatic Resection Surgery
Primary Purpose
Hemorrhage
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
TachoSil®
Surgicel® Original
Sponsored by
About this trial
This is an interventional treatment trial for Hemorrhage focused on measuring Liver resection, Liver transplantation, Liver surgery, Secondary hemostasis
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
TachoSil®
Surgicel® Original
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Percentage of Participants With Intraoperative Hemostasis at Target Bleeding Site 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.
Time to Intraoperative Hemostasis at Target Bleeding Site
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01192022
Brief Title
TachoSil® Versus Surgicel® Original for the Secondary Treatment of Local Bleeding in Adult and Pediatric Patients Undergoing Hepatic Resection Surgery
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 Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhage
Keywords
Liver resection, Liver transplantation, Liver surgery, Secondary hemostasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
253 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TachoSil®
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Surgicel® Original
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
TachoSil®
Intervention Description
Intraoperative application as secondary hemostatic treatment
Intervention Type
Device
Intervention Name(s)
Surgicel® Original
Intervention Description
Intraoperative application as secondary hemostatic treatment
Primary Outcome Measure Information:
Title
Percentage of Participants With Intraoperative Hemostasis at Target Bleeding Site Within 3 Minutes
Description
3 Minutes after the patch was applied to the target bleeding area, the area was observed to see if the bleeding stopped.
Time Frame
within 3 minutes
Secondary Outcome Measure Information:
Title
Percentage of Participants With Intraoperative Hemostasis at Target Bleeding Site Within 5 Minutes
Description
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.
Time Frame
within 5 minutes
Title
Time to Intraoperative Hemostasis at Target Bleeding Site
Description
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.
Time Frame
10 minutes
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
City
Los Angeles
State/Province
California
Country
United States
City
Washington
State/Province
District of Columbia
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Louisville
State/Province
Kentucky
Country
United States
City
New Orleans
State/Province
Louisiana
Country
United States
City
Burlington
State/Province
Massachusetts
Country
United States
City
St. Louis
State/Province
Missouri
Country
United States
City
Newark
State/Province
New Jersey
Country
United States
City
New York
State/Province
New York
Country
United States
City
Charlotte
State/Province
North Carolina
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Charleston
State/Province
South Carolina
Country
United States
City
Memphis
State/Province
Tennessee
Country
United States
City
Nashville
State/Province
Tennessee
Country
United States
City
Charlottesville
State/Province
Virginia
Country
United States
City
Madison
State/Province
Wisconsin
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
26776356
Citation
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.
Results Reference
derived
Learn more about this trial
TachoSil® Versus Surgicel® Original for the Secondary Treatment of Local Bleeding in Adult and Pediatric Patients Undergoing Hepatic Resection Surgery
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