Clinical trial NCT01192022: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hemorrhage
Keywords: Liver resection
Liver transplantation
Liver surgery
Secondary hemostasis
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2010-08-31
Enrollment: 253
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of Participants With Intraoperative Hemostasis at Target Bleeding Site Within 3 Minutes
timeFrame: within 3 minutes
Secondary outcomes:
measure: Percentage of Participants With Intraoperative Hemostasis at Target Bleeding Site Within 5 Minutes
timeFrame: within 5 minutes
measure: Time to Intraoperative Hemostasis at Target Bleeding Site
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: Washington
country: United States
state: District of Columbia
city: Chicago
country: United States
state: Illinois
city: Louisville
country: United States
state: Kentucky
city: New Orleans
country: United States
state: Louisiana
city: Burlington
country: United States
state: Massachusetts
city: St. Louis
country: United States
state: Missouri
city: Newark
country: United States
state: New Jersey
city: New York
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Memphis
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Charlottesville
country: United States
state: Virginia
city: Madison
country: United States
state: Wisconsin
Study officials:
affiliation: Takeda
name: Medical Director
role: STUDY_DIRECTOR
References:
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.