Ignite Creation Date:
2024-05-05 @ 10:14 PM
Last Modification Date:
2024-10-26 @ 10:15 AM
Study NCT ID:
NCT01060189
Status:
COMPLETED
Last Update Posted:
2019-02-05
First Post:
2010-01-28
Brief Title:
Hemostatic Effects of Ulinastatin and Tranexamic Acid in Cardiac Surgery
Sponsor:
Chinese Academy of Medical Sciences Fuwai Hospital
Organization:
Chinese Academy of Medical Sciences Fuwai Hospital
Study Overview
Official Title:
Hemostatic Effects of Ulinastatin and Tranexamic Acid in Cardiac Surgery With Cardiopulmonary Bypass A Pilot Study
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Antifibrinolytic drugs are used to decrease perioperative bleeding and allogeneic transfusions The extensively studied antifibrinolytic drug aprotinin is efficacious but expensive and has been proved to link to higher risks of serious side effects including renal problems myocardial events and strokes in patients undergoing CABG After the secession of aprotinin in 2007 a marked increase of blood loss and transfusions in cardiac surgery took place An effective and secure hemostatic agent is badly needed Ulinastatin urinary trypsin inhibitorUTI is a secreted Kunitz-type protease inhibitor with a wide inhibition spectrum including plasmin Limited studies offered clues to its antifibrinolytic effect Tranexamic acid has been applied for years with convinced efficacy and safety The objective of the study is to evaluate the hemostatic effect of ulinastatin and tranexamic acid in cardiac surgery
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