TachoSil® Versus Surgicel® Original for the Secondary Treatment of Local Bleeding in Adult and Pediatric Patients Undergoing Hepatic Resection Surgery
NCT ID: NCT01192022
Last Updated: 2015-11-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
253 participants
INTERVENTIONAL
2010-08-31
2013-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
TachoSil®
Intraoperative application as secondary hemostatic treatment
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.
Surgicel® Original
Intraoperative application as secondary hemostatic treatment
Interventions
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TachoSil®
Intraoperative application as secondary hemostatic treatment
Surgicel® Original
Intraoperative application as secondary hemostatic treatment
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Los Angeles, California, United States
Washington D.C., District of Columbia, United States
Chicago, Illinois, United States
Louisville, Kentucky, United States
New Orleans, Louisiana, United States
Burlington, Massachusetts, United States
St Louis, Missouri, United States
Newark, New Jersey, United States
New York, New York, United States
Charlotte, North Carolina, United States
Cincinnati, Ohio, United States
Philadelphia, Pennsylvania, United States
Charleston, South Carolina, United States
Memphis, Tennessee, United States
Nashville, Tennessee, United States
Charlottesville, Virginia, United States
Madison, Wisconsin, United States
Countries
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References
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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.
Other Identifiers
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U1111-1130-9121
Identifier Type: REGISTRY
Identifier Source: secondary_id
TC-2402-040-SP
Identifier Type: -
Identifier Source: org_study_id