Ignite Creation Date:
2024-05-06 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 12:46 PM
Study NCT ID:
NCT03535597
Status:
COMPLETED
Last Update Posted:
2023-01-10
First Post:
2018-05-02
Brief Title:
Hemostasis With QuikClot Radial Pad Versus TR Band After Transradial Artery Access
Sponsor:
Memorial Healthcare System
Organization:
Memorial Healthcare System
Study Overview
Official Title:
A Randomized Comparison of the QuikClot Radial Pad Versus the Standard of Care TR Band on Hemostasis After Transradial Artery Access
Status:
COMPLETED
Status Verified Date:
2024-07
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:
To evaluate the efficacy and safety of the QuikClot Radial pad on hemostasis after transradial access TRA compared to the standard of care TR Band to hopefully develop a safe and efficacious technique to achieve more rapid patent hemostasis after TRA and improve patient care by optimizing radial hemostasis management
Detailed Description:
The QuikClot Radial QC pad will be applied over the radial artery access site covered with either a Coban bandage or a Tegaderm dressing after TRA Firm manual compression will then be applied over the QC pad after the sheath is removed for 5 minutes The Coban cohort will then have the Coban bandage removed after an additional 25 minutes then be covered with a Tegaderm dressing The Tegaderm only cohort will be closely observed for 25 minutes after release of manual pressure Both cohorts will remove the Tegaderm dressing the following morning
Consented subjects will be randomly assigned in the cardiac cath lab upon completion of their procedure into one of the following arms
Arm 1 - Standard of Care with a TR Band
Arm 2 - QC pad combined with a Coban bandage
Arm 3 - QC pad combined with a Tegaderm dressing This arm was stopped after the enrollment of 73 patients and replaced by the QCTR Band arm
Arm 4- QC pad was applied on the radial arterial access site with 30 minutes of compression under a TR Band inflated with 8-10 mL of air Then the TR Band was removed leaving the QC pad covered with a Tegaderm dressing
Consented subjects will be randomly assigned in the cardiac cath lab upon completion of their procedure into one of the following arms
Arm 1 - Standard of Care with a TR Band
Arm 2 - QC pad combined with a Coban bandage
Arm 3 - QC pad combined with a Tegaderm dressing This arm was stopped after the enrollment of 73 patients and replaced by the QCTR Band arm
Arm 4- QC pad was applied on the radial arterial access site with 30 minutes of compression under a TR Band inflated with 8-10 mL of air Then the TR Band was removed leaving the QC pad covered with a Tegaderm dressing
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