NCT03535597

Hemostasis With QuikClot® Radial® Pad Versus TR Band® After Transradial Artery Access

A Randomized Comparison of the QuikClot® Radial® Pad Versus the Standard of Care TR Band® on Hemostasis After Transradial Artery Access

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 355 (actual)
• Sponsor: Memorial Healthcare System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 QC/TR 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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Quikclot Radial (QC) Pad	The QC pad will be applied over the radial artery access site covered with either a Coban™ bandage, a Tegaderm™ dressing, or a TR Band after TRA.

Timeline

• Start date: 2018-08-01
• Primary completion: 2022-12-28
• Completion: 2022-12-28
• First posted: 2018-05-24
• Last updated: 2024-09-24
• Results posted: 2024-09-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study