Ignite Creation Date:
2024-05-06 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05774691
Status:
RECRUITING
Last Update Posted:
2024-05-31
First Post:
2023-03-03
Brief Title:
Routine Versus Selective Protamine Administration to Reduce Bleeding Complications After Transcatheter Aortic Valve Implantation POPular ACE TAVI
Sponsor:
St Antonius Hospital
Organization:
St Antonius Hospital
Study Overview
Official Title:
Routine Versus Selective Protamine Administration to Reduce Bleeding Complications After Transcatheter Aortic Valve Implantation
Status:
RECRUITING
Status Verified Date:
2024-05
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:
Heparin reversal by protamine administration after transcatheter aortic valve implantation TAVI may reduce bleeding events However protamine can also cause life-threatening allergic reactions High-quality evidence regarding the clinical safety and efficacy of routine protamine administration after TAVI is lacking
The aim of this clinical trial is to determine if routine protamine administration compared with selective protamine administration reduces the risk of cardiovascular mortality or bleeding within 30 days after transcatheter aortic valve implantation
The aim of this clinical trial is to determine if routine protamine administration compared with selective protamine administration reduces the risk of cardiovascular mortality or bleeding within 30 days after transcatheter aortic valve implantation
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None