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Fibrin Sealant Vapor-Heated Solvent/Detergent-treated

Phase 3

Cardiac Surgery Requiring Cardiopulmonary Bypass and Median Sternotomy | Small molecule | Cardiovascular |Baxter International Inc.|Last Updated: Apr 5, 2017

Success Probability

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment -

FDA Designations

No designations recorded

Clinical trial landscape

Fibrin Sealant Vapor-Heated Solvent/Detergent-treated · 2 trials · 4 indications

Phase 3 2
NCT00161733Safety and Hemostatic Efficacy of Fibrin Sealant Vapor Heated, Solvent/Detergent Treated (FS VH S/D) Compared With Currently Licensed TISSEEL VH Fibrin Sealant in Subjects Undergoing Cardiac SurgeryCardiac Surgery Requiring Cardiopulmonary Bypass and Median Sternotomy
COMPLETED- Analytics
NCT00161902Efficacy and Safety of Fibrin Sealant Vapor Heated Solvent/Detergent Treated (FS VH S/D) for Hemostasis in Subjects Undergoing Total Hip ReplacementHip Replacement Surgery
COMPLETED- Analytics
PHASE3COMPLETED
Safety and Hemostatic Efficacy of Fibrin Sealant Vapor Heated, Solvent/Detergent Treated (FS VH S/D) Compared With Currently Licensed TISSEEL VH Fibrin Sealant in Subjects Undergoing Cardiac Surgery
Cardiac Surgery Requiring Cardiopulmonary Bypass and Median Sternotomy
NCT00161733-
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PHASE3COMPLETED
Efficacy and Safety of Fibrin Sealant Vapor Heated Solvent/Detergent Treated (FS VH S/D) for Hemostasis in Subjects Undergoing Total Hip Replacement
Hip Replacement Surgery
NCT00161902-
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
Fibrin Sealant Vapor Heated Solvent/Detergent Treated (FS VH S/D)DRUG -
TISSEEL VH fibrin sealantDRUG -
Fibrin Sealant Vapor-Heated Solvent/Detergent-treatedDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites22

Inclusion Criteria: All subjects accepted for this study must be: * Informed of the nature of the study and have provided written informed consent * \>= 18 years of age * Scheduled to undergo cardiac surgery requiring CPB and median sternotomy * Able and willing to comply with the procedures requi...

Countries:United StatesAustriaGermanyNetherlands
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