Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06549842
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-06
Brief Title:
Safe and Fast Radial Hemostasis Using Synergistic Strategies SAFE FAST Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Safe and Fast Radial Hemostasis Using Synergistic Strategies SAFE FAST Trial
Status:
RECRUITING
Status Verified Date:
2024-08
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 Safe and Fast Radial Hemostasis using Synergistic Strategies SAFE amp FAST trial is an interventional study aimed at reducing the incidence of radial artery occlusion RAO rebound bleeding and the required compression time after transradial approach TRA procedures which have become the default access for coronary procedures globally The hypothesis is that combining lower-dose heparin and radial hemostasis with simultaneous ipsilateral ulnar artery compression could achieve these improved outcomes
Detailed Description:
Patients referred for diagnostic trans-radial cardiac catheterization who meet the inclusion criteria will be randomized into two groups Group 1 will receive a standard heparin dose 50 UKg with a total compression time of 2 hours using the TR band Group 2 will receive a reduced heparin dose 25 UKg and a compression time of 60 minutes using the VASOBand with simultaneous ipsilateral ulnar artery compression
The studys primary endpoint is a composite of rebound bleeding post-procedural RAO and hematoma formation Radial artery patency will be evaluated using ultrasonography
With an expected complication rate of 82 in Group 1 and 45 in Group 2 a sample size of 207 patients per group will provide an 80 power to demonstrate non-inferiority for the treatment group at the alpha 25 level The statistical analysis plan will use descriptive statistics for baseline data and 95 confidence intervals for outcome variables If non-inferiority is demonstrated there will be a superiority test performed to examine if Group 2 is superior
In conclusion the SAFE FAST trial intends to establish a safer quicker protocol for hemostasis after TRA procedures with the potential to reduce patient recovery time and improve procedure throughput in cardiac catheterization laboratories
The studys primary endpoint is a composite of rebound bleeding post-procedural RAO and hematoma formation Radial artery patency will be evaluated using ultrasonography
With an expected complication rate of 82 in Group 1 and 45 in Group 2 a sample size of 207 patients per group will provide an 80 power to demonstrate non-inferiority for the treatment group at the alpha 25 level The statistical analysis plan will use descriptive statistics for baseline data and 95 confidence intervals for outcome variables If non-inferiority is demonstrated there will be a superiority test performed to examine if Group 2 is superior
In conclusion the SAFE FAST trial intends to establish a safer quicker protocol for hemostasis after TRA procedures with the potential to reduce patient recovery time and improve procedure throughput in cardiac catheterization laboratories
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