N/A
N=355
Hemostasis With QuikClot® Radial® Pad Versus TR Band® After Transradial Artery Access
Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT03535597 ↗Enrolled (actual)
355
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Initial Successful Hemostasis — 85; 88; 51; 74 Participants — p=0.906
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Quikclot Radial (QC) Pad (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Memorial Healthcare System
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Initial Successful Hemostasis |
85; 88; 51; 74 | 0.906 |
| PRIMARY Total Time to Hemostasis |
131.5; 33.3; 10.9; 37.2 | <0.001 sig |
| SECONDARY Radial Artery Occlusion (RAO) |
5; 4; 4; 3 | 0.744 |
| SECONDARY Forearm Hematoma (EASY Classification) |
6; 9; 5; 8 | 0.594 |
| SECONDARY Incidence of Pain/Numbness of the Forearm |
5; 10; 8; 9 | 0.284 |
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.
Eligibility Criteria
Inclusion Criteria
- Patients undergoing cardiac catheterization (CC) and/or percutaneous coronary intervention (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, edoxaban), patients will be excluded if DOAC taken within 48 hours and eGFR > 30 ml/min or DOAC taken within 72 hours and eGFR 1.5
- Liver Failure
- Life-threatening illness that the 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.
Data sourced from ClinicalTrials.gov (NCT03535597). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.