Comparison of the Hemostatic Patch to Fibrin Sealant (TachoSil®) in Subjects Undergoing Hepatic Surgery
NCT ID: NCT01324349
Last Updated: 2014-03-03
Study Results
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View full resultsBasic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2011-02-28
2011-09-30
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
SINGLE
Study Groups
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Veriset Hemostatic Patch
Veriset Hemostatic Patch
Veriset Hemostatic Patch
Topical hemostat
Fibrin Sealant (TachoSil®)
Fibrin Sealant (TachoSil®)
Fibrin Sealant (TachoSil®)
Topical hemostat
Interventions
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Veriset Hemostatic Patch
Topical hemostat
Fibrin Sealant (TachoSil®)
Topical hemostat
Eligibility Criteria
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Inclusion Criteria
* Presence of an appropriate target bleeding site (TBS) as defined by the protocol
Exclusion Criteria
* In subjects with documented history of cirrhosis, subject has uncorrected platelet count \<60,000 per mm³ as determined by laboratory tests performed immediately prior to surgery
* Subject has severe coagulopathy defined as INR \> 2.0
* Subject has Total Bilirubin \>2.5mg/dL
* Subject has an active local infection at the Target Bleeding Site
* Study procedure involves a liver transplant recipient
18 Years
ALL
No
Sponsors
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Medtronic - MITG
INDUSTRY
Responsible Party
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Principal Investigators
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Amy Pollack, MD
Role: STUDY_DIRECTOR
Medtronic - MITG
Locations
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Innsbruck, , Austria
Ghent, , Belgium
Leuven, , Belgium
Hanover, , Germany
Heidelberg, , Germany
München, , Germany
Countries
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Other Identifiers
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COVEULV0032
Identifier Type: -
Identifier Source: org_study_id
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