Ignite Creation Date:
2024-05-06 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06215378
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-22
First Post:
2023-12-22
Brief Title:
Antagonization of Heparin With Protamine Sulfate After TAVI
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Antagonization of Heparin With Protamine Sulfate to Lower All Neurological Ischemic and Hemorrhagic Events After Transcatheter Aortic Valve Implantation for Aortic Stenosis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
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:
ATLANTIS-Prota
Brief Summary:
Transcatheter aortic valve replacement TAVR is now the first therapeutic option offered to high and intermediate risk patients with symptomatic aortic stenosis but even to low-risk when the aortic valve is tricuspid and the transfemoral approach is suitable Vascular and bleeding complications are the most frequent procedure-related unwanted events associated with increased short-term morbidity and mortality Selection of the appropriate vascular access site and pre-closing devices as well as stent implantation mitigate these complications
ACT-guided heparin reaching a target of 300 seconds or more is recommended prior to the placement of the guiding sheath in the common femoral artery Protamine sulfate is the heparin antidote which antagonizes 100 of its anti-IIa activity and 60 of its anti-Xa activity Reversal of heparin using protamine sulfate is recommended for transapical and complicated transfemoral aortic valve placementHowever there is a great heterogeneity of protamine use in daily practice and supportive evidence for the prevention of bleeding complications as well as its safety is lacking In addition the radial approach for the second vascular access is more commonly used as well as the use of echo-guided femoral puncture further questioning reversal of heparin when the procedure has been successfully completed without overt bleeding complications
Our study aims to demonstrate the superiority of a strategy of systematic ACT-guided heparin administration followed by systematic antagonization with protamine sulfate over usual of care to reduce in-hospital mortality vascularbleeding complications stroke and transcient ischemic attack myocardial infarction or red blood cell transfusion from randomization to hospital discharge
ACT-guided heparin reaching a target of 300 seconds or more is recommended prior to the placement of the guiding sheath in the common femoral artery Protamine sulfate is the heparin antidote which antagonizes 100 of its anti-IIa activity and 60 of its anti-Xa activity Reversal of heparin using protamine sulfate is recommended for transapical and complicated transfemoral aortic valve placementHowever there is a great heterogeneity of protamine use in daily practice and supportive evidence for the prevention of bleeding complications as well as its safety is lacking In addition the radial approach for the second vascular access is more commonly used as well as the use of echo-guided femoral puncture further questioning reversal of heparin when the procedure has been successfully completed without overt bleeding complications
Our study aims to demonstrate the superiority of a strategy of systematic ACT-guided heparin administration followed by systematic antagonization with protamine sulfate over usual of care to reduce in-hospital mortality vascularbleeding complications stroke and transcient ischemic attack myocardial infarction or red blood cell transfusion from randomization to hospital discharge
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?:
False
Is an FDA AA801 Violation?:
None