A Randomized Comparison of the QuikClot® Radial® Pad Versus the Standard of Care TR Band® on Hemostasis After Transradial Artery Access (TRA)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Memorial Healthcare System
- Enrollment
- 300
- Locations
- 2
- Primary Endpoint
- Initial Successful Hemostasis
Study Overview
Brief Summary
To evaluate the efficacy and safety of the QuikClot® Radial® pad on hemostasis after TRA, compared to the standard of care TR Band®, with the goal 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® 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 QuikClot® Radial® 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 the following three arms:
Arm 1 - Standard of Care with a TR Band® Arm 2 - QuikClot® Radial® pad combined with a Coban™ bandage Arm 3 - QuikClot® Radial® pad combined with a Tegaderm™ dressing
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients undergoing CC and/or PCI via the radial artery as part of their standard of care treatment
- •Patients able and willing to give written informed consent
- •Patient > 18 years of age
Exclusion Criteria
- •Patients presenting with acute ST segment elevation myocardial infarction (STEMI)
- •Oral anticoagulation therapy as described below:
- •If on a DOAC (direct acting oral anticoagulants - ie dabigatran, rivaroxaban, apixaban, endoxaban), patients will be excluded if DOAC taken within 48 hours and eGFR > 30 ml/min or DOAC taken within 72 hours and eGFR < 30 ml/min.
- •If patient is on warfarin, excluded if INR > 1.5
- •Liver Failure
- •Life threatening illness that patient would not be expected to live more than 6 months post procedure
- •Major unanticipated event in the cardiac cath lab (i.e. cardiac arrest) of an already consented patient, but before randomization, where the operator believes participation in this trial is now inappropriate.
- •Thrombocytopenia, with a platelet count of < 75,000.
Outcomes
Primary Outcomes
Initial Successful Hemostasis
Time Frame: 3 hours
Initial successful hemostasis is defined as no evidence of external bleeding from the TRA puncture site or expanding hematoma of the forearm after completion of the above described TR Band® and QuikClot® Radial® pad protocols, without the need for reinflation of air in the TR Band® or reapplication of manual pressure over the QuikClot® Radial® pad secured with either a Coban™ bandage or Tegaderm™ dressing, or use of manual compression over the arteriotomy site.
Total Time to Hemostasis
Time Frame: 3 hours
Total time to hemostasis was calculated as the time needed from sheath removal to achieving complete hemostasis. All additional protocol-directed recompression and/or weaning times needed to obtain complete hemostasis were added to calculate the total time to hemostasis.
Secondary Outcomes
- Radial Artery Occlusion (RAO)(1 hour)
- Forearm Hematoma (EASY Classification)(3 hours)
- Incidence of Pain/Numbness of the Forearm(1 hour)