Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00161733
Status:
COMPLETED
Last Update Posted:
2017-04-05
First Post:
2005-09-08
Brief Title:
Safety and Hemostatic Efficacy of Fibrin Sealant Vapor Heated SolventDetergent Treated FS VH SD Compared With Currently Licensed TISSEEL VH Fibrin Sealant in Subjects Undergoing Cardiac Surgery
Sponsor:
Baxter Healthcare Corporation
Organization:
Baxter Healthcare Corporation
Study Overview
Official Title:
Evaluation of the Topical Hemostatic Efficacy and Safety of Fibrin Sealant Vapor Heated SolventDetergent Treated Compared With Currently Licensed TISSEEL VH Fibrin Sealant in Subjects Undergoing Cardiac Surgery
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to demonstrate equivalent hemostatic efficacy and safety between FS VH SD and TISSEEL VH fibrin sealant in subjects undergoing cardiac surgery requiring cardiopulmonary bypass If bleeding is still present after conventional surgical methods to achieve hemostasis have been applied FS VH SD or Tisseel VH are applied Achievement of hemostasis within 5 minutes is compared between the study groups
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None